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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Cross-reference
Reason / purpose:
reference to same study
Reference
Endpoint:
skin irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
See attached justification in section 13.2
Reason / purpose:
read-across source
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
not specified
Type of coverage:
not specified
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5ml
- Concentration (if solution): 100%
Duration of treatment / exposure:
4 h
Observation period:
1h, 1d, 2d, 3d, 7d
Number of animals:
4
Details on study design:

SCORING SYSTEM:
Irritation was assessed and allocated a numerical value based on the following:
- Erythema and Eschar Formation
No erythema = 0;
Very slight erythema (barely perceptible) = 1;
Well-defined erythema = 2;
Moderate to severe erythema = 3;
Severe erythema (beet redness) to slight eschar formation (injuries in depth) = 4.

- Oedema Formation:
No oedema = 0;
Very slight oedema (barely perceptible) = 1;
Slight oedema (edges of area well-defined by definite raising) = 2;
Moderate oedema (raised approximately 1 mm) = 3;
Severe oedema (raised more than 1 mm and extending beyond area of exposure) = 4.
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
animal: all animals
Time point:
24/48/72 h
Score:
0.92
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
1.11
Max. score:
2
Reversibility:
fully reversible within: 7 d
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0.08
Max. score:
1
Reversibility:
fully reversible within: 7 d
Interpretation of results:
GHS criteria not met
Conclusions:
The test substance was not qualified as irritating nor corrive according to the OECD TG 404.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
2019
Report Date:
1995

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
not specified

Test system

Type of coverage:
not specified
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5ml
- Concentration (if solution): 100%
Duration of treatment / exposure:
4 h
Observation period:
1h, 1d, 2d, 3d, 7d
Number of animals:
4
Details on study design:

SCORING SYSTEM:
Irritation was assessed and allocated a numerical value based on the following:
- Erythema and Eschar Formation
No erythema = 0;
Very slight erythema (barely perceptible) = 1;
Well-defined erythema = 2;
Moderate to severe erythema = 3;
Severe erythema (beet redness) to slight eschar formation (injuries in depth) = 4.

- Oedema Formation:
No oedema = 0;
Very slight oedema (barely perceptible) = 1;
Slight oedema (edges of area well-defined by definite raising) = 2;
Moderate oedema (raised approximately 1 mm) = 3;
Severe oedema (raised more than 1 mm and extending beyond area of exposure) = 4.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
animal: all animals
Time point:
24/48/72 h
Score:
0.92
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
1.11
Max. score:
2
Reversibility:
fully reversible within: 7 d
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0.08
Max. score:
1
Reversibility:
fully reversible within: 7 d

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance was not qualified as irritating nor corrive according to the OECD TG 404.