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Administrative data

Description of key information

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
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:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
not specified
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Duration of treatment / exposure:
Single application
Observation period:
14 days
Number of animals:
3
Irritation parameter:
erythema score
Basis:
animal: observations in three animals
Time point:
24/48/72 h
Score:
1.67
Max. score:
3
Reversibility:
fully reversible within: 14 days
Remarks on result:
positive indication of irritation
Irritation parameter:
edema score
Basis:
animal: observations in three animals
Time point:
24/48/72 h
Score:
0.57
Max. score:
2
Reversibility:
fully reversible within: 7 days
Remarks on result:
positive indication of irritation

Table: Skin irritation scores

Observation Time

Erythema

Oedema

Animal 1

Animal 2

Animal 3

Animal 1

Animal 2

Animal 3

1h

2

0

1

1

0

1

24h

2

2

1

0

1

1

48h

2

2

0

0

1

0

72h

3

3

0

2

0

0

7 day

4

2

-

0

0

-

14 day

0

0

-

0

0

-

Mean of 24/48/72h

2.3

2.3

0.3

0.7

0.7

0.3

Table: Observations of treated area

Observation Time

Animal 1

Animal 2

Animal 3

Discoloration

Dry/

Rough/

Chapped

Scaling/

Desquamation/

New skin

Discoloration

Dry/

Rough/

Chapped

Scaling/

Desquamation/

New skin

Discoloration

Dry/

Rough/

Chapped

Scaling/

Desquamation/

New skin

1h

 

 

 

 

 

 

 

 

 

2 day

 

 

 

 

x

 

 

 

 

3 day

 

 

 

 

x

 

 

 

 

7 day

 

x

x

x

x

x

 

 

 

14 day

 

 

x

 

x

 

 

 

 

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
The registration substance was investigated for its skin irritaiton property according to OECD 404. It was found to be irritating to skin.
Executive summary:

The registration substance was investigated for its skin irritaiton property according to OECD 404.

Among the three rabbits treated, two rabbits exhibited erythema of mean score of 2.3 for 24,48, and 72 hours reading and exhibited discoloration, dryness and scaling at reading time 7 and 14 day. The registration substance was found to be irritating to skin.

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
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:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1mL
Duration of treatment / exposure:
single application
Observation period (in vivo):
up to 72 hours if no effect at reading time 72 hours; up to 7 days if no effect at reading time 7 day; up to 14 days if still effect present at reading time 7 day.
Number of animals or in vitro replicates:
3
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0.44
Max. score:
2
Reversibility:
fully reversible within: 48 hours
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48hours
Remarks on result:
no indication of irritation

Eye Irritation Score

Reading time

Animal

Opacity

Iris

Conjunctivae

Redness

Chemosis

1h

1

0

0

2

2

2

0

0

1

2

3

0

0

2

3

24 hours

1

0

0

1

1

2

0

0

2

1

3

0

0

1

1

48 hours

1

0

0

0

0

2

0

0

0

0

3

0

0

0

0

72 hours

1

0

0

0

0

2

0

0

0

0

3

0

0

0

0

Interpretation of results:
GHS criteria not met
Conclusions:
The registration substance is not irritating according to the results obtained in the OECD 405 study.
Executive summary:

The registration substance was investigated for its eye irritation property according to the OECD 405. Schwelling and redening of conjunctivae was observed only at reading time of 24 hours. No classification is warranted.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Justification for classification or non-classification

The registration substance was investigated for its skin irritaiton property according to OECD 404. It was found to be irritating to skin.

The registration substance was investigated for its eye irritaiton property according to OECD 405. It was found to be not irritating to eye.

Based on GHS criteria, it should be classified as skin irritant, Category 2.

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