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Diss Factsheets

Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
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 sanitization study of chemical 2-Nitro-4’-hydroxydiphenylamine (CAS No: 54381-08-7) was conducted on 10 female Hartley albino guinea pigs to determine the skin sensitizing effects caused by the application of test chemical.
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
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

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Hartley albino
Sex:
female
Details on test animals and environmental conditions:
No data available

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal and epicutaneous
Vehicle:
propylene glycol
Concentration / amount:
Intradermal : 0.1% test chemical in propylene glycol and Freund's complete adjuvant (FCA)
Dermal: 25% in propylene glycol
Day(s)/duration:
One week
Adequacy of induction:
not specified
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
propylene glycol
Concentration / amount:
25% in propylene glycol
Day(s)/duration:
No data available
Adequacy of challenge:
not specified
No. of animals per dose:
10 female guinea pigs
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE: Intradermal
- No. of exposures: 1
- Exposure period: one week
- Test groups: 10 guinea pigs
- Control group: no data
- Site: intradermal injection
- Frequency of applications: single application
- Duration: one week
- Concentrations: 0.1% test chemical in propylene glycol and Freund's complete adjuvant (FCA)


A. II.INDUCTION EXPOSURE: Dermal
- No. of exposures: 1
- Exposure period: no data
- Test groups: 10 guinea pigs
- Control group: no data
- Site: area over the injection site
- Frequency of applications: no data
- Duration: no data
- Concentrations: 25% in propylene glycol


B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: After a 2-week
- Exposure period: no data
- Test groups: 10 guinea pigs
- Control group: no data
- Site: a previously untreated site.
- Concentrations: 25% in propylene glycol
- Evaluation (hr after challenge): no data

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Group:
test chemical
Dose level:
25%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No skin sensitizing effects were observed.
Remarks on result:
no indication of skin sensitisation

In vivo (LLNA)

Cellular proliferation data / Observations:
No skin sensitizing effects were observed.

Applicant's summary and conclusion

Interpretation of results:
other: Not sensitizing
Conclusions:
The test material 2-Nitro-4’-hydroxydiphenylamine (CAS No: 54381-08-7) was considered to be not sensitizing to the skin of 10 female Hartley albino guinea pigs.
Executive summary:

Skin sanitization study of chemical 2-Nitro-4’-hydroxydiphenylamine (CAS No: 54381-08-7) was conducted on 10 female Hartley albino guinea pigs to determine the skin sensitizing effects caused by the application of test chemical.

 

In induction, the guinea pigs were received a single intradermal injection of 0.1%2-Nitro-4’-hydroxydiphenylamine inpropylene glycol and Freund's complete adjuvant (FCA). One week after injection, an occlusive patch containing 25% chemical in propylene glycol was applied to an area over the injection site.The test site was pretreated 24 hours earlier with 10% sodium lauryl sulfate.

 

After a non treatment period of 2 weeks, animals were challenged to a previously untreated site at concentration of 25%in propylene glycol and later skin reactions were examined.

 

Since there was no known evidence of contact sensitization, the chemical 2-Nitro-4’-hydroxydiphenylamine (CAS No: 54381-08-7)was considered to be not sensitizing to the skin of10 female Hartley albino guinea pigs.