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Diss Factsheets

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data is from peer reviewed journal

Data source

Reference
Reference Type:
publication
Title:
FINAL REPORT ON THE SAFETY ASSESSMENT OF HC ORANGE NO. 1
Author:
Cosmetic Ingredient Review Expert Panel
Year:
1988
Bibliographic source:
International Journal of Toxicology, 17(Suppl. 4).-21-37, 1998

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: as mentioned below
Principles of method if other than guideline:
Skin irritation study of 2-Nitro-4’-hydroxydiphenylamine (CAS No: 54381-08-7) was conducted on intact skin of six New Zealand White rabbits to observe its irritation efficacy.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
2-Nitro-4’-hydroxydiphenylamine
Cas Number:
54381-08-7
Molecular formula:
C12H10N2O3
IUPAC Name:
2-Nitro-4’-hydroxydiphenylamine
Test material form:
solid
Details on test material:
- Name of test material (as cited in study report): HC Orange No. 1
- Molecular formula: C12H10N2O3
- Molecular weight: 405.582 g/mol
- Substance type: Organic
- Physical state: solid
- Purity: >99%
-InChI: 1S/C30H31N/c1-29(2,23-11-7-5-8-12-23)25-15-19-27(20-16-25)31-28-21-17-26(18-22-28)30(3,4)24-13-9-6-10-14-24/h5-22,31H,1-4H3
-Smiles: N(c1ccc(cc1)C(c1ccccc1)(C)C)c1ccc(cc1)C(c1ccccc1)(C)C
Specific details on test material used for the study:
- Name of test material (as cited in study report): HC Orange No. 1
- Molecular formula: C12H10N2O3
- Molecular weight: 405.582 g/mol
- Substance type: Organic
- Physical state: solid
- Purity: >99%
-InChI: 1S/C30H31N/c1-29(2,23-11-7-5-8-12-23)25-15-19-27(20-16-25)31-28-21-17-26(18-22-28)30(3,4)24-13-9-6-10-14-24/h5-22,31H,1-4H3
-Smiles: N(c1ccc(cc1)C(c1ccccc1)(C)C)c1ccc(cc1)C(c1ccccc1)(C)C

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
No Data Available

Test system

Type of coverage:
open
Preparation of test site:
other: Intact skin
Vehicle:
other: Aqueous
Controls:
not specified
Amount / concentration applied:
500mg
Duration of treatment / exposure:
24 hours
Observation period:
At 24 or 72 hours
Number of animals:
2
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The chemical was removed after 24 hours
- Time after start of exposure: at 24 or 72 hours

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No evidence of erythema or edema was observed at 24 or 72 hours.

Applicant's summary and conclusion

Interpretation of results:
other: Not irritating
Conclusions:
The test material 2-Nitro-4’-hydroxydiphenylamine (CAS No: 54381-08-7) was considered to be not irritating to the intact skin of New Zealand White rabbits.

Executive summary:

Skin irritation study of 2-Nitro-4’-hydroxydiphenylamine (CAS No: 54381-08-7) was conducted on intact skin of six New Zealand White rabbits to observe its irritation efficacy.

 

In this study, aqueous slurry of 500 mg of2-Nitro-4’-hydroxydiphenylaminewas applied tointact skin of each rabbit for 24 hours under non-occlusive condition.

 

The slurry was removed after 24 hours and reactions were scored at 24 or 72 hours.

 

Since there wereno evidence of erythema or edema observed at 24 or 72 hours,the chemical2-Nitro-4’-hydroxydiphenylamine (CAS No: 54381-08-7) wasconsidered to be not irritating to the intact skin ofNew Zealand Whiterabbits.