Registration Dossier
Registration Dossier
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EC number: 221-490-4 | CAS number: 3118-97-6
Skin irritation / corrosion
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:
- 1 980
- Bibliographic source:
- Contact Dermatitis; Volume 6; Pg. no. 330-336; 1980
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- 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 substance name:
- 1-(2,4-dimethylphenylazo)-2-naphthol
- EC Number:
- 221-490-4
- EC Name:
- 1-(2,4-dimethylphenylazo)-2-naphthol
- Cas Number:
- 3118-97-6
- Molecular formula:
- C18H16N2O
- IUPAC Name:
- 1-(2,4-dimethylphenylazo)-2-naphthol
- Details on test material:
- SMILES:Cc1ccc(N=Nc2c3ccccc3ccc2O)c(C)c1
Constituent 1
- 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 or test system 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.
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