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Toxicological information

Skin irritation / corrosion

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Administrative data

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:
other: According to OECD Guideline 404 (Acute Dermal Irritation / Corrosion). Non-GLP.
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
according to
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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): P0434 (dodecyl dimethyl amine oxide)
- Molecular formula (if other than submission substance): Not available
- Molecular weight (if other than submission substance): 235.7
- Substance type: Pure active substance
- Physical state: Liquid
- Analytical purity: Not available
- Impurities (identity and concentrations): None
- Composition of test material, percentage of components: See below
- Isomers composition: Not available
- Purity test date: Not available
- Lot/batch No.: Not available
- Expiration date of the lot/batch: Not available
- Stability under test conditions: Not available
- Storage condition of test material: Room temperature
- Other: None

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals 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

Test system

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

Results and discussion

In vivo

Resultsopen allclose all
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:
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: Intact and 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: 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: 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:
0
Max. score:
4
Reversibility:
other: No edema was observed
Remarks on result:
other: Intact and 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

Any other information on results incl. tables

 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    

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant)
Remarks:
Migrated information Criteria used for interpretation of results: EU
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.