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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

No studies are available for C12 AO, however data are available for C12-14 AO, which contains approximately 60-80% of the C12 AO with the remainder being analogues differing only in the carbon chainlength. Based on read-across to these studies, the substance is expected to be irritating to the skin and corrosive to the eyes of rabbits.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
supporting study
Study period:
No data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
according to guideline
Guideline:
other: No data
Deviations:
not applicable
Principles of method if other than guideline:
The test material was evaluated for skin irritation to normal and abraded skin of eight New Zealand white rabbits as a 2 % aqueous solution. Observations were recorded at 24- and 72 h.
GLP compliance:
no
Remarks:
Study pre-dates GLP.
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
occlusive
Preparation of test site:
other: Abraded and non-abraded.
Vehicle:
water
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): 0.6 % AO in water

Duration of treatment / exposure:
24 h
Observation period:
72 h
Number of animals:
Eight
Details on study design:
TEST SITE
- Area of exposure: 1.5x2 inches
- % coverage: no data
- Type of wrap if used: test material applied to a plastic coverlet, secured in place using plastic tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data


SCORING SYSTEM: Draize
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: Mean of 24 & 72 hrs
Score:
0.5
Max. score:
4
Reversibility:
other: 1/8 animals had a score of 1 at 72 hrs
Remarks on result:
other: maximum score observed at 72 hrs = 1
Irritation parameter:
edema score
Basis:
mean
Time point:
other: Mean of 24 & 72 hrs
Score:
0.125
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: Maximum score at 24 h = 1
Other effects:
Throughout the treatment and observation period all animals appeared clinically normal. No evidence of pain was observed. All animals thrived and responded normally to external stimuli.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
A 2 % solution of the test material caused slight erythema and occasional oedema on the abraded and non-abraded skin over the 72 h observation period. The 2 % solution of the test material (equivalent to 0.6 % AO) showed a primary irritation index of 0.93.
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
24-05-1982 to 26-05-1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
according to guideline
Guideline:
other: U.S. Federal Register, Vol. 41 (188): 42572 (27th September 1976). US CFR 49(173).
Deviations:
not specified
GLP compliance:
no
Remarks:
Study pre-dates GLP.
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
occlusive
Preparation of test site:
other: Clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): 30 %w/w
Duration of treatment / exposure:
4 h
Observation period:
48 h
Number of animals:
Six
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 4 h
Score:
0.33
Max. score:
4
Reversibility:
no data
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 4 h
Score:
0
Max. score:
4
Reversibility:
other: Not applicable
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 48 h
Score:
2.33
Max. score:
4
Reversibility:
no data
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 48 h
Score:
0.66
Max. score:
4
Reversibility:
no data
Other effects:
No data
Interpretation of results:
other: Not corrosive
Remarks:
Criteria used for interpretation of results: other: US Federal Register.
Conclusions:
The study indicates that the test substance does not have a corrosive action on the skin following a 4 h exposure period.
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
10-1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
according to guideline
Guideline:
other: US Federal Register Vol. 38 (187): 1500:41, 1973.
Deviations:
not specified
GLP compliance:
no
Remarks:
Study pre-dates GLP.
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: stated as 'recognised breeders'
- Age at study initiation: 12-14 weeks
- Weight at study initiation: average bw 2.15 kg
- Housing: caged singly
- Diet: Rank Hovis MacDougal rabbit diet, ad libitum
- Water: filtered water ad libitum
- Acclimation period:

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 +/- 2
- Humidity (%): 50-70
- Air changes (per hr): not stated
- Photoperiod: natural lighting conditions

Type of coverage:
occlusive
Preparation of test site:
other: intact and abraded
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): 6.5 % as supplied
Duration of treatment / exposure:
24 hours
Observation period:
72 h
Number of animals:
Six
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: 10 %
- Type of wrap if used: Smith & Nephew Elastic bandage (occlusive).

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not done
- Time after start of exposure:

SCORING SYSTEM: Draize
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: mean of 24 & 72 hours
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: intact skin
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: mean of 24 & 72 hours
Score:
1.5
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: intact skin
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: mean of 24 & 72 hours
Score:
1.5
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: intact skin
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
other: mean of 24 & 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: intact skin
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
other: mean of 24 & 72 hours
Score:
1.5
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: intact skin
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
other: mean of 24 & 72 hours
Score:
1.5
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: mean of 24 & 72 hours
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: mean of 24 & 72 hours
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: mean of 24 & 72 hours
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
animal #4
Time point:
other: mean of 24 & 72 hours
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
animal #5
Time point:
other: mean of 25 & 72 hours
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
animal #6
Time point:
other: mean of 24 & 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: intact skin
Other effects:
No data
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance gave a primary irritation score of 2.07 over 72 h which is classed as a moderate irritant to the skin of the rabbit according to the author of the study report. Based on EU classification criteria, the test substance is not classified as irritating to skin.
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
01-06-1981 to 03-06-1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
according to guideline
Guideline:
other: US Federal Register Vol. 41 (188): 42572 (27th September 1976). US CFR 49 (173).
Deviations:
not specified
GLP compliance:
no
Remarks:
Study pre-dates GLP.
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
occlusive
Preparation of test site:
other: Clipped
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): 30 %w/w

Duration of treatment / exposure:
4 h
Observation period:
48 h
Number of animals:
6
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 48 h
Score:
2
Max. score:
4
Reversibility:
no data
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 48 h
Score:
0.66
Max. score:
4
Reversibility:
no data
Other effects:
No data
Interpretation of results:
other: Not Corrosive
Remarks:
Criteria used for interpretation of results: other: US Federal Register
Conclusions:
No reactions were apparent at the 4 h observation. Well-defined erythema was apparent at all 6 treated sites at the 48 h observation and very slight oedema was apparent at 4 treated sites at this time. The test substance did not cause destruction of intact skin of the albino rabbit and based on this result would not be regarded as a corrosive agent according to the Definitions in the US Federal Register Test. The Class 8 classification of the UN Economics and Social Council was slightly corrosive.
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1978-02-22
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
- Treatment time is 24 hours instead of 4 hours. 0.4ml of test substance dosed instead of 0.5ml. Systemic toxicity, body weight and histopathology results are not given.
Principles of method if other than guideline:
None
GLP compliance:
no
Remarks:
pre-GLP
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Kuiper's rabbit ranch, Gary, Indiana
- Age at study initiation: Not available
- Weight at study initiation: 2103 - 2781 gm
- Housing: Individually in hanging wire-mesh cages in temperature and humidity controlled quarters
- Diet (e.g. ad libitum): Purina rabbit chow, ad libitum
- Water (e.g. ad libitum): Water, ad libitum
- Acclimation period: 16 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): As per S.O.P.
- Humidity (%): As per S.O.P.
- Air changes (per hr): As per S.O.P.
- Photoperiod (hrs dark / hrs light): As per S.O.P.


IN-LIFE DATES: 1978-02-22
Type of coverage:
occlusive
Preparation of test site:
abraded
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.4 ml of test substance
- Concentration (if solution): Undiluted


VEHICLE
- Amount(s) applied (volume or weight with unit): Not applicable
- Concentration (if solution): Not applicable
- Lot/batch no. (if required): Not applicable
- Purity: Not applicable
Duration of treatment / exposure:
0.4 ml of undiluted P7270 was applied to one abraded and one intact test site on each of the three New Zealand white rabbits (2 male and 1 female)
using 38x38 mmParke Davis Readi-bandage with a 20x20 mm felt pad secured with wrappings of 75 mm elastoplast tape for 24 hours. After 24 hours the test sites were wiped with a damp cloth. The sites were examined for erythema and edema using Draize method of scoring at 24 and 72 hours.
Observation period:
24 and 72 hours
Number of animals:
3 animals (2 male and 1 female)
Details on study design:
TEST SITE
- Area of exposure: Back of animals (intact and abraded skin site)
- % coverage: Test substance applied using 38x38 mmParke Davis Readi-bandage with a 20x20 mm felt pad
- Type of wrap if used: 75 mm elastoplast tape


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Test substance removed with a damp cloth
- Time after start of exposure: 24 hours


SCORING SYSTEM:
Erythema and eschar scoring from 0-4 with 0 = no erythema, 1 = very slight erythema (barely perceptible), 2 = well defined erythema, 3 = moderate to severe erythema, 4 = severe erythema (beet redness) to slight eschar formation (injuries in depth).
Edema scoring from 0-4 with 0 = no edema, 1 = very slight edema (barely perceptible), 2 = slight edema (edges of area well defined by definite raising), 3 = moderate edema (raised approximately 1mm), 4 = severe edema (raised more than 1 mm nd extending beyond the area of exposure).
Primary irritation index: 0-2 = mild, 2-5 = moderately irritating, 5-6 = moderately to severely irritating, 6-8 = severely irritating
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24 hours
Score:
2
Max. score:
8
Reversibility:
not reversible
Remarks:
in 72 hrs
Remarks on result:
other: Intact and abraded skin site
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 hours
Score:
1
Max. score:
4
Reversibility:
not reversible
Remarks:
in 72 hours
Remarks on result:
other: Intact and abraded skin site
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 hours
Score:
1
Max. score:
4
Reversibility:
not reversible
Remarks:
in 72 hours
Remarks on result:
other: Intact and abraded skin site
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 72 hours
Score:
8
Max. score:
8
Reversibility:
not reversible
Remarks:
in 72 hours
Remarks on result:
other: Intact and abraded skin site
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 hours
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks:
in 72 hours
Remarks on result:
other: Intact and abraded skin site
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72 hours
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks:
in 72 hours
Remarks on result:
other: Intact and abraded skin site
Irritant / corrosive response data:
For Intact and Abraded skin site- PII at 24 hours: 2.0, PII at 72 hours: 8.0
Other effects:
One animal showed blanching at 24 hours at abraded skin site.

 Animal No.

 Skin site

Degree of erythema after---- [Observation time]

 Degree of edema after---- [Observation time]  

 Ø 24/72 h >= 2.3 but < 4.0   

 

 

 24 h

 72 h

 24 h

 72 h

 Erythema

 Edema

 

 Intact

 

 

 

 

 

 

 30970

 

 1

 4

 1

 4

Yes 

 Yes  

 

 

Ø 24/ 72 h = 2.5

 Ø 24/ 72 h = 2.5

  => Positive responder

 30979

 

 1

 4

 1

 4

  Yes

  Yes

 

 

 Ø 24/ 72 h = 2.5

 Ø 24/ 72 h = 2.5

  => Positive responder

 31017

 

 1

 4

 1

 4

  Yes

  Yes

 

 

Ø 24/ 72 h = 2.5

Ø 24/ 72 h = 2.5     

  => Positive responder

 

 Abraded

 

 

 

 

 

 

 30970

 

 1

 4

 1

 4

  Yes

  Yes

 

 

  Ø 24/ 72 h = 2.5

  Ø 24/ 72 h = 2.5

  => Positive responder

 30979

 

 1

 4

 1

 4

  Yes

  Yes

 

 

  Ø 24/ 72 h = 2.5

  Ø 24/ 72 h = 2.5

  => Positive responder

31017

 

 1

 4

 1

 4

  Yes

  Yes

 

 

  Ø 24/ 72 h = 2.5

  Ø 24/ 72 h = 2.5  

=> Positive responder    
Interpretation of results:
Category 2 (irritant)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
P7270 (28% DDAO) is classified as a Category 2 skin irritant according to EU GHS classification.
Executive summary:

0.4 ml of undiluted P7270 (28% DDAO) was applied to one abraded and one intact test site on each of the three New Zealand white rabbits (2 male and 1 female) using 38x38 mmParke Davis Readi-bandage with a 20x20 mm felt pad secured with wrappings of 75 mm elastoplast tape for 24 hours. After 24 hours the test sites were wiped with a damp cloth. The sites were examined for erythema and edema using Draize method of scoring at 24 and 72 hours.

Occlusive 24 hour exposure to 0.4 ml of undiluted DDAO produced very slight erythema and very slight edema at the intact and abraded sites of all the test animals at 24 hours. At 72 hours severe erythema (beet redness) to slight eschar formation (injuries in depth) and severe edema (raised more than 1 mm extending beyond the area of exposure) was served at the intact and abraded of all the test animals.

One animal showed blanching at 24 hours at abraded skin site.

Thus, 28% DDAO/ C10-C16 alkyldimethyl, N-Oxide is classified as a Category 2 skin irritant according to EU GHS classification.

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1978-09-21
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
- Treatment time is 24 hours instead of 4 hours. 0.4ml of test substance dosed instead of 0.5ml. Systemic toxicity, body weight and histopathology results are not given.
Principles of method if other than guideline:
None
GLP compliance:
no
Remarks:
pre-GLP
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Kings wheel
- Age at study initiation: Not available
- Weight at study initiation: 2058.9 - 3285.9 gm
- Housing: Individually in stainless steel cages with stainless steel slatted flooring
- Diet (e.g. ad libitum): Purina lab rabbit chow
- Water (e.g. ad libitum): Tap water; ad libitum
- Acclimation period: Minimum 7 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.4°C - 21.1°C
- Humidity (%): 72%
- Air changes (per hr): Not available
- Photoperiod (hrs dark / hrs light): 12 hours on/off fluorescent lighting


IN-LIFE DATES: 1978-09-21
Type of coverage:
occlusive
Preparation of test site:
abraded
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.4 ml of P0434
- Concentration (if solution): Undiluted


VEHICLE
- Amount(s) applied (volume or weight with unit): Not applicable
- Concentration (if solution): Not applicable
- Lot/batch no. (if required): Not applicable
- Purity: Not applicable
Duration of treatment / exposure:
0.4 ml of undiluted P0434 was applied to one abraded and one intact test site on each of the three female New Zealand white rabbits
using Parke Davis Readi-bandage secured with hypo-allergenic tape. Test sites were wrapped with gauze and elastoplast tape for 24 hours. After 24 hours the test sites were wiped with a wet paper towel. The sites were examined for erythema and edema using Draize method of scoring at 24 and
72 hours.
Observation period:
24 and 72 hours
Number of animals:
3 female rabbits
Details on study design:
TEST SITE
- Area of exposure: Back of animals (right side - abraded, left side - intact)
- % coverage: Test substance applied using Parke-Davis Readi-Bandage
- Type of wrap if used: Gauze and elastoplast tape


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Test sites wiped with wet paper towel
- Time after start of exposure: 24 hours


SCORING SYSTEM: Draize method
Erythema and eschar scoring from 0-4 with 0 = no erythema, 1 = very slight erythema (barely perceptible), 2 = well defined erythema, 3 = moderate to severe erythema, 4 = severe erythema (beet redness) to slight eschar formation (injuries in depth).
Edema scoring from 0-4 with 0 = no edema, 1 = very slight edema (barely perceptible), 2 = slight edema (edges of area well defined by definite raising), 3 = moderate edema (raised approximately 1mm), 4 = severe edema (raised more than 1 mm nd extending beyond the area of exposure).
Primary irritation index: 0-2 = mild, 2-5 = moderately irritating, 5-6 = moderately to severely irritating, 6-8 = severely irritating
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
other: no edema was observed
Remarks on result:
other: intact skin site
Irritation parameter:
edema score
Basis:
animal #1
Time point:
48 h
Remarks on result:
not measured/tested
Remarks:
intact skin site
Irritation parameter:
edema score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
other: no edema was observed
Remarks on result:
other: intact skin site
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
other: no edema was observed
Remarks on result:
other: intact skin site
Irritation parameter:
edema score
Basis:
animal #2
Time point:
48 h
Remarks on result:
not measured/tested
Remarks:
intact skin site
Irritation parameter:
edema score
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
other: no edema was observed
Remarks on result:
other: intact skin site
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
other: no edema was observed
Remarks on result:
other: intact skin site
Irritation parameter:
edema score
Basis:
animal #3
Time point:
48 h
Remarks on result:
not measured/tested
Remarks:
intact skin site
Irritation parameter:
edema score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
other: no edema was observed
Remarks on result:
other: intact skin site
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
not reversible
Remarks:
in 72 hours
Remarks on result:
other: intact skin site
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
48 h
Remarks on result:
not measured/tested
Remarks:
intact skin site
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks:
in 72 hours
Remarks on result:
other:
Remarks:
intact skin site
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Remarks:
in 72 hours
Remarks on result:
other: intact skin site
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
48 h
Remarks on result:
not measured/tested
Remarks:
intact skin site
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks:
in 72 hours
Remarks on result:
other: intact skin site
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Remarks:
in 72 hours
Remarks on result:
other: intact skin site
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
48 h
Remarks on result:
not measured/tested
Remarks:
intact skin site
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks:
in 72 hours
Remarks on result:
other: intact skin site
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24 hours
Score:
1.67
Max. score:
8
Reversibility:
not reversible
Remarks:
in 72 hours
Remarks on result:
other: Intact and abraded skin site
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 72 hours
Score:
4
Max. score:
8
Reversibility:
not reversible
Remarks:
in 72 hours
Remarks on result:
other: Intact and abraded skin site
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 hours
Score:
>= 1 - <= 2
Max. score:
4
Reversibility:
not reversible
Remarks:
in 72 hours
Remarks on result:
other: abraded skin site
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 hours
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks:
in 72 hours
Remarks on result:
other: abraded skin site
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 hours
Score:
0
Max. score:
4
Reversibility:
other: No edema was observed
Remarks on result:
other: abraded skin site
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72 hours
Score:
0
Max. score:
4
Reversibility:
other: No edema was observed
Remarks on result:
other: abraded skin site
Irritant / corrosive response data:
For intact and abraded skin site at 24 hours PII is 1.67 and at 72 hours PII is 4.0.
Other effects:
None reported

 Animal No.

 Skin site

Degree of erythema after---- [Observation time]

 Degree of edema after---- [Observation time]  

 Ø 24/72 h >= 2.3 but < 4.0   

 

 

 24 h

 72 h

 24 h

 72 h

 Erythema

 Edema

 

 Intact

 

 

 

 

 

 

 RB 608 78

 

 1

 4

 0

 0

Yes 

 No  

 

 

Ø 24/ 72 h = 2.5

 Ø 24/ 72 h = 0

  => Positive responder

 RB 524 78

 

 2

 4

 0

 0

  Yes

  No

 

 

 Ø 24/ 72 h = 3.0

 Ø 24/ 72 h = 0

  => Positive responder

 RB 525 78

 

 2

 4

 0

 0

  Yes

  No

 

 

Ø 24/ 72 h = 3.0

Ø 24/ 72 h = 0     

  => Positive responder

 

 Abraded

 

 

 

 

 

 

 RB 608 78

 

 1

 4

 0

 0

  Yes

  No

 

 

  Ø 24/ 72 h = 2.5

  Ø 24/ 72 h = 0

  => Positive responder

 RB 524 78

 

 2

 4

 0

 0

  Yes

  No

 

 

  Ø 24/ 72 h = 3.0

  Ø 24/ 72 h = 0

  => Positive responder

RB 525 78

 

 2

 4

 0

 0

  Yes

  No

 

 

  Ø 24/ 72 h = 3.0

  Ø 24/ 72 h = 0  

=> Positive responder    
Interpretation of results:
Category 2 (irritant)
Conclusions:
P0434 (27.8% DDAO) is classified as a Category 2 skin irritant according to EU GHS classification.
Executive summary:

0.4 ml of undiluted P0434 (27.8% DDAO) was applied to one abraded and one intact test site on each of the three female New Zealand white rabbits using Parke Davis Readi-bandage secured with hypo-allergenic tape. Test sites were wrapped with gauze and elastoplast tape for 24 hours. After 24 hours the test sites were wiped with a wet paper towel. The sites were examined for erythema and edema using Draize method of scoring at 24 and 72 hours.

Very slight to well-defined erythema at the intact and abraded sites of all the test animals at 24 hours. At 72 hours severe erythema (beet redness) to slight eschar formation (injuries in depth) were observed at the intact and abraded of all the test animals. No edema was observed at any time point.

Thus, 27.8% DDAO/ C10-C16 alkyldimethyl, N-Oxide is classified as a Category 2 skin irritant according to EU GHS classification.

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
other: FHSA/CPSC Design, 16 CFR 1500
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Kuiper Rabbitry, Gary, Indiana, USA
- Age at study initiation: 8-10 weeks old
- Weight at study initiation: no data
- Housing: individually housed in stainless steel cages
- Diet: Purina rabbit chow ad libitum
- Water: ad libitum
- Acclimation period: minimum 4 days

ENVIRONMENTAL CONDITIONS
Temperature, humidy and light were controlled according to the receommendations contained in DHEW Publication No. 86-23 (NIH) Guide for the Care and Use of Laboratory Animals
Type of coverage:
occlusive
Preparation of test site:
other: shaved and shaved + abraded
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 mL
- Concentration (if solution): 5 % active or 2.5 % active in aqueous solution as supplied

Duration of treatment / exposure:
4 hours
Observation period:
24 and 72 hours
Number of animals:
3 animals per dose level
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm2
- % coverage: not stated
- Type of wrap if used:Site was covered with a two layer gauze patch secured with non-irritating porous adhesive tape and the entire site was wrapped with a 4 mil plastic wrap and secured with more tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Excess material was removed from the site (method not specified)
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: average of 24 & 72 hours scores
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: 5 % AO solution
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: average of 24 & 72 hour scores
Score:
0
Max. score:
4
Remarks on result:
other: 5 % AO solution
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: average of 24 & 72 hour scores
Score:
1.5
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: 5 % AO solution
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: average of 24 & 72 hour scores
Score:
0
Max. score:
4
Remarks on result:
other: 5 % AO solution
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: average of 24 & 72 hour scores
Score:
0
Max. score:
4
Remarks on result:
other: 5 % AO solution
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: average of 24 & 72 hour scores
Score:
0
Max. score:
4
Remarks on result:
other: 5 % AO solution
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: average of 24 & 27 hour scores
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: 2.5 % AO Solution
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: average of 24 & 72 hour scores
Score:
0
Max. score:
4
Remarks on result:
other: 2.5 % AO Solution
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: average of 24 & 72 hour scores
Score:
0
Max. score:
4
Remarks on result:
other: 2.5 % AO Solution
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: average of 24 & 72 hour scores
Score:
0
Max. score:
4
Remarks on result:
other: 2.5 % AO Solution
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: average of 24 & 72 hour scores
Score:
0
Max. score:
4
Remarks on result:
other: 2.5 % AO Solution
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: average of 24 & 72 hour scores
Score:
0
Max. score:
4
Remarks on result:
other: 2.5 % AO Solution

Only the results from intact skin are used in the scoring

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In this study solutions containing C12-14 amine oxide at 2.5 or 5 %w/w were not irritating to the skin of rabbits.
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
24-05-1982 to 26-05-1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
according to guideline
Guideline:
other: US Federal Register Vol. 41 (188): 24572 (27th September 1976). US CFR 49 (173).
Deviations:
not specified
GLP compliance:
no
Remarks:
Study pre-dates GLP.
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
occlusive
Preparation of test site:
other: Clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): 30 %w/w
Duration of treatment / exposure:
4 h
Observation period:
48 h
Number of animals:
6 animals
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 4 h
Score:
0.66
Max. score:
4
Reversibility:
not fully reversible within: the 48 h observation period.
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 4 h
Score:
0
Max. score:
4
Reversibility:
other: Not applicable
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 48 h
Score:
1.83
Max. score:
4
Reversibility:
not fully reversible within: the 48 h observation period
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 48 h
Score:
0
Max. score:
4
Reversibility:
other: Not applicable
Other effects:
No data
Interpretation of results:
other: Not corrosive
Remarks:
Criteria used for interpretation of results: other: US Federal Register
Conclusions:
Slight erythema was apparent at 4 of the 6 treated sites following a 4 h exposure to the test material. Slight increase in the observable reactions was apparent during the course of the study. No necrosis or other evidence of corrosive action was apparent during the study. The results indicate that the test material does not have a corrisive action on the skin following a 4 h exposure period.
Endpoint:
skin irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
10-1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
according to guideline
Guideline:
other: US Federal Register Vol. 38 (187) 1500:42 (1973).
Deviations:
not specified
GLP compliance:
no
Remarks:
Study pre-dates GLP.
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: No data
- Age at study initiation: 12-14 weeks
- Weight at study initiation: 2.08 kg average
- Housing: caged singly
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17+/-2
- Humidity (%): 50-70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): natural lighting conditions

Vehicle:
unchanged (no vehicle)
Controls:
other: The untreated eye served as control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 mL
- Concentration (if solution): 6 % AO

Duration of treatment / exposure:
Group 1: Eyes remained unwashed for the 72 h test period
Group 2: 5 sec
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
Group 1: Six
Group 2: Three
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Group 1 - no washing; Group 2 - 20 mL sterile distilled water at 37°C
- Time after start of exposure: Group 2 - 5 seconds

SCORING SYSTEM: Draize

Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: mean of 24, 48 & 72 hours
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: max score for single animal = 1
Irritation parameter:
iris score
Basis:
mean
Time point:
other: mean of 24, 48 & 72 hours
Score:
0.6
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: max score for single animal = 1
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: mean o f24, 48 & 72 hours
Score:
2.5
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: 4 animals score >=2.7
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: mean o f24, 48 & 72 hours
Score:
2.2
Max. score:
4
Reversibility:
not fully reversible within:
Remarks on result:
other: 3 animals score >=2.3
Other effects:
No data
Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results of this study the 6 % solution of amine oxide was irritating to the eyes of rabbits.
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1978-05-17
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
Not applicable
GLP compliance:
no
Remarks:
Pre-GLP
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Kuiper's Rabbit Ranch, Gary, Indiana
- Age at study initiation: Not available
- Weight at study initiation: 2002 To 2940 gms
- Housing:Individually in hanging wire mesh cages
- Diet (e.g. ad libitum): Purinaw rabbit Chow, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): In accordance with recommendations contained in H.E.W. Publication No.74-23 (N.I.H.), entitled"Guide for the care and Use of Laboratory Animals"
- Humidity (%): In accordance with recommendations contained in H.E.W. Publication No.74-23 (N.I.H.),
- Air changes (per hr): In accordance with recommendations contained in H.E.W. Publication No.74-23 (N.I.H.),
- Photoperiod (hrs dark / hrs light):In accordance with recommendations contained in H.E.W. Publication No.74-23 (N.I.H.),


IN-LIFE DATES: From: To:
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml P7270
- Concentration (if solution): Undiluted P7270 applied to the Group I and II, while a 10% (w/w) aqueous solution P7270 was applied to Group III


VEHICLE
- Amount(s) applied (volume or weight with unit): distilled water (for Group III)
- Concentration (if solution): Not applicable
- Lot/batch no. (if required): Not applicable
- Purity: Not applicable
Duration of treatment / exposure:
Group I: 0.1 ml of undiluted P7270 was applied and eyes were not rinsed.
Group II: 0.1 ml of undiluted P7270 was applied and eyes were rinsed with 20 ml lukewarm water approximately for 4 seconds following dosing.
Group III: 0.1 ml of a 10% (w/w) solution of P7270 in distilled water was applied and eyes of animals were not rinsed.
Observation period (in vivo):
After application of test material: 1 hour, 1,2,3,4,7,14,21,28 and 35 days.
Number of animals or in vitro replicates:
3 rabbits of either sex per group.
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): eyes of animals in Group II were rinsed with 20 ml lukewarm water
- Time after start of exposure: approximately for 4 seconds following dosing


SCORING SYSTEM: Draize scoring system


TOOL USED TO ASSESS SCORE: fluorescein
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1 hour
Score:
6.67
Max. score:
6.67
Reversibility:
not fully reversible within: 35 days
Remarks on result:
other: Group I: 0.1 ml undiluted test substance, no rinse
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
One animal with grade 1.5 and two with grade 0
Time point:
other: 1 hour
Score:
> 1 - < 1.5
Max. score:
1.5
Reversibility:
not fully reversible within: 35 days
Remarks on result:
other: Group I: 0.1 ml undiluted test substance, no rinse
Irritation parameter:
iris score
Basis:
mean
Remarks:
all animals with grade 1
Time point:
other: 1 hour, 1 day, 2 days
Score:
1
Max. score:
1
Reversibility:
not fully reversible within: 35 days
Remarks on result:
other: Group I: 0.1 ml undiluted test substance, no rinse
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
One animal with grade 2, one with grade 1.5 and one with grade 1
Time point:
other: 1 hour
Score:
> 1 - < 2
Max. score:
2
Reversibility:
not fully reversible within: 35 days
Remarks on result:
other: Group I: 0.1 ml undiluted test substance, no rinse
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
all animals with grade 3
Time point:
other: 1 hour
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 35 days
Remarks on result:
other: Group I: 0.1 ml undiluted test substance, no rinse
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1 day
Score:
7.67
Max. score:
7.67
Reversibility:
not fully reversible within: 35 days
Remarks on result:
other: Group I: 0.1 ml undiluted test substance, no rinse
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
two animals with grade 2 and one with grade 1
Time point:
other: 1 day
Score:
> 1 - < 2
Max. score:
2
Reversibility:
not fully reversible within: 35 days
Remarks on result:
other: Group I: 0.1 ml undiluted test substance, no rinse
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
two animals with grade 2 and one with 1.5
Time point:
other: 1 day
Score:
> 1.5 - < 2
Max. score:
2
Reversibility:
not fully reversible within: 35 days
Remarks on result:
other: Group I: 0.1 ml undiluted test substance, no rinse
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
two animals with grade 3 and one with grade 3.5
Time point:
other: 1 day
Score:
> 3 - < 3.5
Max. score:
3.5
Reversibility:
not fully reversible within: 35 days
Remarks on result:
other: Group I: 0.1 ml undiluted test substance, no rinse
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 2 days
Score:
7.17
Max. score:
7.17
Reversibility:
not fully reversible within: 35 days
Remarks on result:
other: Group I: 0.1 ml undiluted test substance, no rinse
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
one animal with grade 2 and two with grade 1
Time point:
other: 2 days
Score:
> 1 - < 2
Max. score:
2
Reversibility:
not fully reversible within: 35 days
Remarks on result:
other: Group I: 0.1 ml undiluted test substance, no rinse
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
one animal with grade 2 and two with grade 1.5
Time point:
other: 2 days
Score:
> 1.5 - < 2
Max. score:
2
Reversibility:
not fully reversible within: 35 days
Remarks on result:
other: Group I: 0.1 ml undiluted test substance, no rinse
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
two animals with grade 3 and one with grade 3.5
Time point:
other: 2 days
Score:
> 3 - < 3.5
Max. score:
3.5
Reversibility:
not fully reversible within: 35 days
Remarks on result:
other: Group I: 0.1 ml undiluted test substance, no rinse
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 3 days
Score:
7.83
Max. score:
7.83
Reversibility:
not fully reversible within: 35 days
Remarks on result:
other: Group I: 0.1 ml undiluted test substance, no rinse
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
one animal with grade 2, one with 1.5 and one with grade 1
Time point:
other: 3 days
Score:
> 1 - < 2
Max. score:
2
Reversibility:
not fully reversible within: 35 days
Remarks on result:
other: Group I: 0.1 ml undiluted test substance, no rinse
Irritation parameter:
iris score
Basis:
mean
Remarks:
two animals with grade 1 and one with grade 2
Time point:
other: 3 and 4 days
Score:
> 1 - < 2
Max. score:
2
Reversibility:
not fully reversible within: 35 days
Remarks on result:
other: Group I: 0.1 ml undiluted test substance, no rinse
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
one animal with grade 2.5, one with 2 and one with grade 1.5
Time point:
other: 3 days
Score:
> 1.5 - < 2.5
Max. score:
2.5
Reversibility:
not fully reversible within: 35 days
Remarks on result:
other: Group I: 0.1 ml undiluted test substance, no rinse
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
one animal with grade 2.5, one with 3 and one with grade 3.5
Time point:
other: 3 days
Score:
> 2.5 - < 3.5
Max. score:
3.5
Reversibility:
not fully reversible within: 35 days
Remarks on result:
other: Group I: 0.1 ml undiluted test substance, no rinse
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 4 days
Score:
8
Max. score:
8
Reversibility:
not fully reversible within: 35 days
Remarks on result:
other: Group I: 0.1 ml undiluted test substance, no rinse
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
one animal with grade 3, one with 1.5 and one animal with grade 1
Time point:
other: 4 days
Score:
> 1 - < 3
Max. score:
3
Reversibility:
not fully reversible within: 35 days
Remarks on result:
other: Group I: 0.1 ml undiluted test substance, no rinse
Irritant / corrosive response data:
Group I: Irreversible irritation upto day 35.
Group II: Irriversible irritation upto day 35.
roup III: All signs of irritation were reversed within 21 days.
Other effects:
Death of one animal of Group III. And the cause of death of animal was unable to determine.
Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Undiluted P7270 (28% dodecyl dimethyl amine oxide) causes irreversible irritation to rabbit eyes.
Executive summary:

The eyes of three groups of 3 rabbits were instilled with 0.1 ml of P7270 (28% dodecyl dimethyl amine oxide). Group I and II received undiluted P7270 while group III animals were treated with a 10% aqueous solution of P7270 in distilled water. The eyes of the Group I and Group III rabbits were not rinsed and the eyes of the Goup II rabbits were rinsed, approximately 4 seconds following instillation of the test material, with 20 ml of lukewarm distilled water.

Group I: The maximum average score was 8.0 on 4th day. The observable response included irreversible corneal opacity in all three animals till 35 days, iridic response with grade 1 was observed, conjunctival redness upto grade 2 was observed and conjunctival chemosis upto grade 3(swelling with lids about half closed) was observed. The reactions were not fully reversed till 35 days.

Group II: The maximum average score was 6.0 on 3rd day. The observable response included irreversible corneal opacity in one animal till 35 days, iridic response upto grade 1 was observed,conjunctival redness upto grade 2.5 (more diffuse beefy red areas) was observed and conjunctival chemosis upto grade 2.5 was observed which was no fully reversed within 35 days.

Group III: The maximum average score was 4.8 on 2nd day. The observable response included corneal opacity which was reversed within 7 days, iridic response upto grade 1 was observed,conjunctival redness upto grade 2 (more diffuse crimson red areas) was observed and conjunctival chemosis upto grade 2 was observed. All reactions were fully reversed within 21 days in all animals. In this group one rabbit was found dead and the cause of death was unable to determine.

From these observations it can be concluded that P7270 caused irreversible irritation to the rabbit eye. Thus P7270 (28% DDAO) can be classified as GHS category 1.

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1978-09-12 To 1978-10-18
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
Not applicable
GLP compliance:
no
Remarks:
Pre-GLP
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Kings Wheel
- Age at study initiation: Young adult
- Weight at study initiation: Males: 1608.6 gm, Females: 2031.5 gm
- Housing:Individually in stainless steel cages with stainless steel slatted flooring
- Diet (e.g. ad libitum): Purins Lab Rabbit Chow (By Ralston Purina Company)
- Water (e.g. ad libitum): Tap water, from bottles with tubules made of refined steel, ad libitum
- Acclimation period: minimum 7 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22
- Humidity (%): 46-72
- Air changes (per hr): Not available
- Photoperiod (hrs dark / hrs light): 12/12 (Fluorescent lighting)


IN-LIFE DATES: From: 1978-09-12 To: 1978-10-18
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml P0434
- Concentration (if solution): Undiluted


VEHICLE
- Amount(s) applied (volume or weight with unit): Not applicable
- Concentration (if solution): Not applicable
- Lot/batch no. (if required): Not applicable
- Purity: Not applicable
Duration of treatment / exposure:
GroupI: Eyes of animals were not rinsed, and observations are noted directly.
Group II: Eyes of animals were rinsed after 4 seconds by spraying 20 ml of lukewarm tap water after application.
Observation period (in vivo):
At 1 hour, 1,2,3,4,7,14,21,28 and 35 days.
Number of animals or in vitro replicates:
3 animals of either sex per group.
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Eyes of Group II animals were rinsed by spraying 20 ml of lukewarm tap water from a hypodermic syringe fitted with a snubbed 18 gauge needle into the eye under moderate pressure.
- Time after start of exposure: 4 seconds after application.


SCORING SYSTEM: Draize scoring system


TOOL USED TO ASSESS SCORE: A Pen light
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1 hour
Score:
2.67
Max. score:
2.67
Reversibility:
not fully reversible within: 35 days
Remarks on result:
other: No rinse
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
All animals with grade 0
Time point:
other: 1 hour
Score:
0
Max. score:
0
Reversibility:
not fully reversible within: 35 days
Remarks on result:
other: No rinse
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1 hour, 1,2,3,4,7,14,21,28 and 35 days
Score:
0
Max. score:
0
Reversibility:
other: No iridal response was observed at any time interval
Remarks on result:
other: No rinse
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
All animals with grade 1
Time point:
other: 1 hour, 1,2,3,4,7 days
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: No rinse
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
Two animals with grade 2 and one with grade 1
Time point:
other: 1 hour
Score:
> 1 - < 2
Max. score:
2
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: No rinse
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: day 1
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 35 days
Remarks on result:
other: No rinse
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
All animals with grade 1
Time point:
other: 1,2,3,4,7,14 and 21 days
Score:
1
Max. score:
1
Reversibility:
not fully reversible within: 35 days
Remarks on result:
other: No rinse
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
All animals with grade 2
Time point:
other: day 1
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: No rinse
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: day 2,3
Score:
3.33
Max. score:
3.33
Reversibility:
not fully reversible within: 35 days
Remarks on result:
other: No rinse
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
One animal with grade 2 and two with grade 1
Time point:
other: day 2, 3
Score:
> 1 - < 2
Max. score:
2
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: No rinse
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: day 4
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 35 days
Remarks on result:
other: No rinse
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
One animal with grade 2, one with grade 1 and one with grade 0
Time point:
other: day 4
Score:
> 0 - < 2
Max. score:
2
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: No rinse
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: day 7
Score:
2.67
Max. score:
2.67
Reversibility:
not fully reversible within: 35 days
Remarks on result:
other: No rinse
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
Two animals with grade 1 and one with grade 0
Time point:
other: day 7
Score:
> 0 - < 1
Max. score:
1
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: No rinse
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: days 14, 21
Score:
1
Max. score:
1
Reversibility:
not fully reversible within: 35 days
Remarks on result:
other: No rinse
Irritation parameter:
other: Conjunctivae and chemosis score
Basis:
mean
Remarks:
All animals with grade 0
Time point:
other: 14, 21, 18 and 35 days
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 14days
Remarks on result:
other: No rinse
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 28 and 35 days
Score:
1.67
Max. score:
1.67
Reversibility:
not fully reversible within: 35 days
Remarks on result:
other: No rinse
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
Two animals with grade 2 and one with grade 1
Time point:
other: 28 and 35 days
Score:
> 1 - < 2
Max. score:
2
Reversibility:
not fully reversible within: 35 days
Remarks on result:
other: No rinse
Other effects:
None

Overall irritation/ Corrosion results: For Rinse Group

Irritation parameter  Basis  Time point    Max.score  Reversibility  Remarks 
Overall irritation score  mean 1 hour   3.0 3.0  not fully reversible within:35 days  Rinse 
Cornea score  mean: all animals with grade 0  1 hour  0  0  not fully reversible within:35 days  Rinse 
Iris score    1 hour, 1,2,3,4,7,14,21,28 and 35 days  0  0  No iridal response was observed.  Rinse 
Conjunctival redness score  mean: all animals with grade 1 1 hour, 1,2,3,4 and 7 days  1  1  fully reversible within:14 days  Rinse 
Conjunctival chemosis score  mean  1 hour and day 1  2  2  fully reversible within: day 2  Rinse 
Overall irritation score  mean  day 1  3.67  3.67  not fully reversible within:35 days  Rinse 
Cornea score  mean: Two animals with grade 1 and one with grade 0 day 1,2,3,4  >0 -<1  1  not fully reversible within:35 days  Rinse 
Overall irritation score  mean  days 2,3,4  1.67  1.67  not fully reversible within:35 days  Rinse 
Conjunctival chemosis score  mean: all animals with grade 0  days 2,3,4,7,14,21,28 and 35 days  0   0 fully reversible within:2 days  Rinse 
Overall irritation score mean  day 7  1.33  1.33  not fully reversible within:35 days  Rinse 
Cornea score mean:one animal with grade 1 and two with grade 0  day 7, 14  >0 - <1  1   not fully reversible within:35 days Rinse 
Conjunctival redness score  mean:all animals with grade 0  day 14,21,28 and 35  0  0  fully reversible within:14 days Rinse 
Overall irritation score  mean  day 14, 21,28 and 35  0.33   0.33  not fully reversible within:35 days Rinse 
Cornea score  mean:one animals with grade 1 and two with grade 0  day 14, 21, 28 and 35  >0 - <1   1 not fully reversible within:35 days  Rinse 

GHS Classification:

Animal #  GHS Classification  What it means? Cornea  Iris  Conjunctival redness Conjunctival chemosis  Days to clear by individual animal 
 No rinse (Group I)              
 1 1  Irreversible eye irritation  1.0  0   1.0 2.0  Cornea not reversible by 35 days 
 2 1  Irreversible eye irritation  1.0  0  1.0 1.33  Cornea not reveersible by 35 days 
3  1  Irreversible eye irritation  1.0  0   1.0 1.33 Cornea not reversible by 35 days 
Rinse (Group II)               
 1  1 Irreversible eye irritation  0.0   0  1.0  0.67 Fully reversible within 14 days 
 2  1 Irreversible eye irritation   1.0  0 1.0   0.67 Fully reveersible within 14 days 
 3  1 Irreversible eye irritation   1.0  0  1.0 0.67  Cornea not fully reversible by 35 days 
Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
P0434 (27.8% Dodecyl dimethyl amine oxide) causes irreversible irritation to the rabbit eye.
Executive summary:

The eyes of two groups of 3 rabbits were instilled with 0.1 ml of undiluted P0434 (27.8% DDAO). The eyes of the first group of 3 rabbits were not rinsed and the eyes of the second group of 3 rabbits were rinsed, approximately 4 seconds following instillation of the test material, with 20 ml of lukewarm distilled water.

Group I:The maximum average score was 4.0 at 1day. The observable response included irreversible corneal opacity in all three animals till 35 days, no iridic response was observed, conjunctival redness with grade 1 was observed which was fully reversed within 14 days and conjunctival chemosis upto grade 2 was observed which was fully reversed within 14 days.

Group II: The maximum average score was 3.67 at one day. The observable response included irreversible corneal opacity in one animal till 35 days, no iridic response was observed,conjunctival redness with grade 1 was observed which was fully reversed within 14 days and conjunctival chemosis upto grade 2 was observed which was fully reversed within 2 days.

From these observations it can be concluded that the test material P0434 (27.8% dodecyl dimethyl amine oxide) is causing irreversible irritation to the rabbit eye. Thus 27.8% DDAO can be classified as GHS category 1.

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Principles of method if other than guideline:
Samples were administered into one eye each of three albino rabbits per test article. The eyes were observed and scored at 1, 24, 48, 72 and 168 hours.
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Kuiper Rabbitry, Gary, Indiana, USA
- Age at study initiation: 8-10 weeks old
- Weight at study initiation: no data
- Housing: individually housed in stainless steel cages
- Diet: Purina rabbit chow ad libitum
- Water: ad libitum
- Acclimation period: At least 4 days

ENVIRONMENTAL CONDITIONS
The rabbits were maintained according to the recommendations contained in the DHEW Publication No. 86.23 (NIH): 'Guide for the care and Use of Laboratory Animals'.
Vehicle:
unchanged (no vehicle)
Controls:
other: The conlateral eye served as the untreated control for each rabbit
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): 5% AO (Agent 2108-87-5) 2.5% AO (Agent 2108-87-6)
Duration of treatment / exposure:
Eyes of animals were not rinsed, and observations are noted directly.
Observation period (in vivo):
1, 24, 48, 72 and 168 hours
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
Eyes of animals were not rinsed

SCORING SYSTEM: Draize, JH (1965). Appraisal of the saftey of chemicals in foods, drugs and cosmetics

TOOL USED TO ASSESS SCORE: 2% fluorescein AND uv light
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48 & 72 hours
Score:
19.4
Max. score:
80
Remarks on result:
other: 5 % AO
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 7 days
Score:
21.6
Max. score:
80
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: 5 % AO
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 & 72 hours
Score:
5
Max. score:
10
Remarks on result:
other: 5 % AO
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 7 days
Score:
3.3
Max. score:
10
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: 5 % AO
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48 & 72 hours
Score:
13.3
Max. score:
20
Remarks on result:
other: 5 % AO
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 7 days
Score:
11.3
Max. score:
20
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: 5 % AO
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48 & 72 hours
Score:
16.1
Max. score:
80
Remarks on result:
other: 2.5 % AO
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 7 days
Score:
16.7
Max. score:
80
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 &72 hours
Score:
5
Max. score:
10
Remarks on result:
other: 2.5 % AO
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 7 days
Score:
3.3
Max. score:
10
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: 2.5 % AO
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
12.8
Max. score:
20
Remarks on result:
other: 2.5 % AO
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 7 days
Score:
6.7
Max. score:
20
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: 2.5 % AO
Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation:

No data are available for C12 AO, however data are available for C12 -14 AO which contains approximately 60 -80 % of C12 AO with the remainder being mostly higher chainlength analogues. Read-across to the results of these studies is considered to be appropriate.

In the key study, performed according to OECD TG 404 [Fulfs JC (1978)], C12 -14 AO (0.4 mL, 27.8 %AO) was applied to the intact and abraded skin of 3 female rabbits (New Zealand White) and covered with an occlusive dressing for 24 hours. At the end of the exposure period the treatment sites were wiped with a wet paper towel and reactions noted over a 72 hour period. Very slight to well defined erythema was observed at the intact and abraded sites of all the test animals at 24 hours. At 72 hours severe erythema (beet redness) to slight eschar formation were observed at the intact and abraded sites of all test animals. No oedema was observed at any time point. Similar results were obtained in a supporting study [Dean WP (1978)].

In three further supporting studies, performed according to US Federal Register, vol 41(188): 42572 (27thSeptember 1976), C12 -14 AO (0.5 mL, 30 % AO) was applied to the intact skin of 6 rabbits (albino) and covered with an occlusive dressing for 4 hours. At the end of the exposure period the test substance was removed by wiping with a paper towel moistened with sterile distilled water. The sites were scored immediately and after 48 hours. Erythema and oedema scores increased during the 48 hour observation period. No destruction of intact skin was observed after the four hour exposure.

Three further studies are available performed using lower concentrations of C12 -14 AO. In the first of these [Nicholas P & Jones JR (1976)] performed according to US Federal Register Vol 38 (187): 1500:41 (1973) the substance (0.5 mL, 6 %w/w AO) was applied to the intact and abraded skin of 6 rabbits (New Zealand White) and covered with an occlusive dressing for 24 hours. Very slight to moderate to severe erythema and very slight to slight oedema was observed at the intact and abraded sites of all test animals at 24 hours. At 72 hours no to slight erythema and no to very slight oedema was observed at the intact and abraded sites of all test animals. In the second study the substance (0.5 mL, 0.6 % AO) was applied to the intact and abraded skin of 8 rabbits (New Zealand White) and covered with an occlusive dressing for 24 hours. No to very slight erythema and oedema was observed at the intact and abraded sites of all test animals at 24 and 72 hours. In the third study [Kukulinski M (1997)] performed according to FHSA/CPSC Design, 16 CFR1500 the substance (0.5 mL, 2.5 or 5 %AO) was applied to the intact and abraded skin of 3 rabbits (New Zealand White). At 5 % AO one rabbit had no erythema at 24 hours on had very slight and the third had well defined erythema at the intact sites. At 72 hours two rabbits had no erythema and the third very slight erythema. No oedema was observed at either 24 or 72 hours. At 2.5 % AO very slight erythema was observed in one rabbit at 24 hours. All other scores were zero at both 24 and 72 hours.

Eye irritation

No data are available for C12 AO, however data are available for C12 -14 AO which contains approximately 60 -80 % of C12 AO with the remainder being mostly higher chainlength analogues. Read-across to the results of these studies is considered to be appropriate.

In the key study, performed according to OECD TG 405 [Fulfs JC (1978)] C12 -14 AO (0.1 mL, 27.8 % AO) was instilled into the eyes of two groups of three rabbits (New Zealand White). The eyes of the first group of 3 rabbits were not rinsed and the eyes of the second group of 3 rabbits were rinsed, approximately 4 seconds following instillation of the test substance, with 20 ml of lukewarm distilled water. In the first group the maximum average score was 4.0 at one day. The observable response included irreversible corneal opacity in all three animals up to 35 days. No iridic response was observed. Conjunctival redness with grade 1 and conjunctival chemosis up to grade 2 were observed and fully reversed within 14 days. In the second group the maximum average score was 3.67 at one day. The observable response included irreversible corneal opacity in one animal up to 35 days. No iridic response was observed. Conjunctival redness with grade 1 and conjunctival chemosis up to grade 2 were observed and fully reversed within 2 days. From these observations it is concluded that the test substance caused irreversible damage to the rabbit eye.

In a supporting study performed according to OECD TG 405 [Dean WP (1978)] C12 -14 AO was instilled into the eyes of two groups of three rabbits (New Zealand White). Group I and Group II received 0.1 mL of 28 % AO. Group III received 0.1 mL of a 10 % dilution, i.e. 2.8 % AO. The eyes of the Group I and Group III rabbits were not rinsed and the eyes of the Group II rabbits were rinsed, approximately 4 seconds following instillation of the test material, with 20 mL of lukewarm distilled water. For Group I the maximum average score was 8.0 on 4th day. The observable response included irreversible corneal opacity in all three animals till 35 days. Iridic response with grade 1 was observed. Conjunctival redness up to grade 2 was observed and conjunctival chemosis up to grade 3 (swelling with lids about half closed) was observed. The reactions were not fully reversed up to 35 days. For Group II the maximum average score was 6.0 on the third day. The observable response included irreversible corneal opacity in one animal up to 35 days. Iridic response up to grade 1 was observed. Conjunctival redness up to grade 2.5 (more diffuse beefy red areas) and conjunctival chemosis up to grade 2.5 were observed which were not fully reversed within 35 days. For Group III the maximum average score was 4.8 on the second day. The observable response included corneal opacity which was reversed within 7 days. Iridic response up to grade 1 was observed. Conjunctival redness up to grade 2 (more diffuse crimson red areas) and conjunctival chemosis up to grade 2 were observed. All reactions were fully reversed within 21 days in all animals. In this group one rabbit was found dead and the cause of death was unable to be determined. From these observations it can be concluded that the test substance at a concentration of 28 %AO caused irreversible damage to the rabbit eye. A 10 % dilution of the test substance (i.e. 2.8 % AO) caused irritation that was reversible within 21 days. Two further studies are available performed on lower concentrations of AO. In both of these studies, which used 6 % AO [Nicholas P & Jones JR (1976)] and 5 % or 2.5 % AO [Kukulinski M (1997)] the test substance induced eye irritation effects that were not fully reversible within a 7 -day period. It is not possible to conclude for certain from the 7 -day scores whether the effects would be fully reversed if the observation period had been extended to 21 days, however based on the study performed with 2.8 % AO this seems likely.

Justification for classification or non-classification

C12 AO is classified as Skin Irritant Category 2 on the basis of the reactions seen in the skin irritation studies performed on the read-across substance C12 -14 AO.

The read-across substance C12 -14 AO caused damage to the eyes of rabbits that did not fully reverse during the 21 day observation period. On this basis C12 AO is classified as Eye Damage Category 1.