Registration Dossier

Administrative data

Description of key information

Studies are available that show the substance is 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
Reference
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.
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study
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
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
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:
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

 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)
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.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records
Reference
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:
other: As per OECD guideline 405. Non-GLP
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study
Qualifier:
according to
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  not fully reversible within:35 days  Rinse 
Iris score    1 hour, 1,2,3,4,7,14,21,28 and 35 days  No iridal response was observed.  Rinse 
Conjunctival redness score  mean: all animals with grade 1 1 hour, 1,2,3,4 and 7 days  fully reversible within:14 days  Rinse 
Conjunctival chemosis score  mean  1 hour and day 1  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  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 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   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 Irreversible eye irritation  1.0   1.0 2.0  Cornea not reversible by 35 days 
 2 Irreversible eye irritation  1.0  0  1.0 1.33  Cornea not reveersible by 35 days 
Irreversible eye irritation  1.0   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
Remarks:
Migrated information
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 conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

In the key study, performed according to OECD TG 404 [Fulfs JC (1978)], the substance (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), the substance (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 amine oxide. 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

In the key study, performed according to OECD TG 405 [Fulfs JC (1978)] the test substance (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)] the test substance 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 selection of skin irritation / corrosion endpoint:
Study performed to OECD TG 404 and has a Klimisch score of 2.

Justification for selection of eye irritation endpoint:
Study performed to OECD TG 405 and has a Klimisch score of 2.

Effects on skin irritation/corrosion: highly irritating

Effects on eye irritation: corrosive

Justification for classification or non-classification

The substance is classified as Skin Irritant Category 2 on the basis of the reactions seen in the skin irritation studies.

The substance caused damage to the eyes of rabbits that did not fully reverse during the 21 day observation period and is therefore classified as Eye Damage Category 1.