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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:
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:
Pigmented contact dermatitis from azo dyes. I. Cross-sensitivity in humans.
Author:
TAKEHITO KGZUKA, MINORU TASHIR0, SHIGEHARU SANO, KEIICHI FUJIMOTO,YUMI NAKAMURA, SEIICHI HASHIMOTO AND GEN NAKAMINAM.
Year:
1980
Bibliographic source:
Contact Dermatitis; Volume 6; Pg. no. 330-336; 1980

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: as mentioned below
Principles of method if other than guideline:
A patch test was performed in human patients suffering from pigmented contact dermatitis caused by the commercial Brilliant Lake Red R for test chemical 1-[(2,4-dimethylphenyl)diazenyl]-2-naphthol (CAS No: 3118-97-6) to assess its irritation efficacy.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
SMILES:Cc1ccc(N=Nc2c3ccccc3ccc2O)c(C)c1
Specific details on test material used for the study:
- Name of test material (as cited in study report): C.I. Solvent orange 7
- Molecular formula: C18H16N2O
- Molecular weight : 276.337 g/mol
- Substance type: Organic
- Physical state: Solid
- Smiles : Cc1ccc(N=Nc2c(O)ccc3ccccc23)c(C)c1
- InChI: 1S/C18H16N2O/c1-12-7-9-16(13(2)11-12)19-20-18-15-6-4-3-5-14(15)8-10-17(18)21/h3-11,21H,1-2H3/b20-19

Test animals

Species:
other: Human
Strain:
other: Not applicable
Details on test animals and environmental conditions:
No data available

Test system

Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
other: Petrolatum
Controls:
yes
Amount / concentration applied:
1%
Duration of treatment / exposure:
2 days
Observation period:
24 hours after patch removal
Number of animals:
8
Details on study design:
TEST SITE
- Area of exposure: back of each volunteers
- Type of wrap if used: Finn Chambers® on Scanpor® (Epitest, Ltd. Oy).
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure:24 hours

SCORING SYSTEM: Readings were made according to the ICDRG classification (Wilkinson et a!. 1970)

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24 h
Score:
2
Max. score:
8
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Remarks:
Readings were made according to the ICDRG classification (Wilkinson et a!. 1970) 24 h after the patches were removed.
Irritant / corrosive response data:
Two patients showed positive skin reaction.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
Positive reactions were seen in 2 out of total 8 cases. Thus the test chemical 1-[(2,4-dimethylphenyl)diazenyl]-2-naphthol (CAS No: 3118-97-6) was considered to be irritating in human patients suffering from pigmented contact dermatitis caused by the commercial Brilliant Lake Red R.
Executive summary:

A patch test was performed in human patients suffering from pigmented contact dermatitis caused by the commercial Brilliant Lake Red R for test chemical 1-[(2,4-dimethylphenyl)diazenyl]-2-naphthol (CAS No: 3118-97-6) to assess its irritation efficacy.

 

The patch of 1-[(2,4-dimethylphenyl)diazenyl]-2-naphthol was applied onto the back of each patient for 24 hours by usingFinn Chambers® on Scanpor® (Epitest, Ltd. Oy). After removal of patch, skin reactions were assessed according to the ICDRG classification for 2 days.

 

Twenty-eight healthy female volunteers, aged 20 and 21, were also tested with the sample as controls. None gave a positive reaction.

 

Since thepositive reactions were seen in 2 out of total 8 cases,the test chemical1-[(2,4-dimethylphenyl)diazenyl]-2-naphthol (CAS No: 3118-97-6)was considered to be irritating in human patients suffering from pigmented contact dermatitis caused by the commercial Brilliant Lake Red R.