Registration Dossier
Registration Dossier
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EC number: 226-164-5 | CAS number: 5307-14-2
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Data is from peer reviewed journal
Data source
Reference
- Reference Type:
- publication
- Title:
- Contact dermatitis in hair dressers: The Italian experience
- Author:
- Guerra L, Tosti A, Bardazzi F, Pigatto P, Lisi P, Santucci B, Valsecchi R, Schena D, Angelini G, Sertoli A,
- Year:
- 1 992
- Bibliographic source:
- Contact Dermatitis. 1992 Feb; 26(2):101-7.
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as below
- Principles of method if other than guideline:
- GIRDCA standard serie
- GLP compliance:
- not specified
- Type of study:
- patch test
- Justification for non-LLNA method:
- not specified
Test material
- Reference substance name:
- 2-nitro-p-phenylenediamine
- EC Number:
- 226-164-5
- EC Name:
- 2-nitro-p-phenylenediamine
- Cas Number:
- 5307-14-2
- Molecular formula:
- C6H7N3O2
- IUPAC Name:
- 2-nitrobenzene-1,4-diamine
- Reference substance name:
- 2 nitro p phenylenediamine
- IUPAC Name:
- 2 nitro p phenylenediamine
- Details on test material:
- Name of test material (as cited in study report): 2 nitro p phenylenediamine (2NPPD)Substance type: OrganicPhysical state: Solid
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- human
- Strain:
- other: not applicable
- Sex:
- male/female
- Details on test animals and environmental conditions:
- No data
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- other: No data
- Vehicle:
- petrolatum
- Remarks:
- 1% pet.
- Concentration / amount:
- No data
Challengeopen allclose all
- Route:
- other: No data
- Vehicle:
- petrolatum
- Remarks:
- 1% pet.
- Concentration / amount:
- No data
- No. of animals per dose:
- 302 hair dressers
- Details on study design:
- This study was performed from January 1985 to June 1990 and involved 302 hairdressers with contact dermatitis,43 males and 259 females, aged from 14 to 66 years (mean age 24.6 years. Patch tests were performed with the GIRDCA standard series and with the hairdresser’s series. Patients were also tested with other substances specific to their work and with their own products. Patch tests were performed according to ICDRG recommendations, using Finn Chambers on Scanpor tape and Hermal-Trolab allergens. The reactions were read at 2 and 3 days
- Challenge controls:
- No data
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- test chemical
- No. with + reactions:
- 24
- Total no. in group:
- 302
- Clinical observations:
- Weak Sensitizing
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 72.0. Group: test group. No with. + reactions: 24.0. Total no. in groups: 302.0. Clinical observations: Weak Sensitizing.
Any other information on results incl. tables
Not specified
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- A multicenter study was performed in 9 Italian centers by members of the GIRDCA' to evaluate the frequency and source of contact sensitization in a group of 302 hairdressers with dermatitis. Occupational habits and use of preventive measures were specifically investigated both in these 302 hairdressers. The results showed the presence of an occupationally relevant sensitization in 60.9% of the 302 hairdressersPositive reactions to 2 NPPD occurred in 24 patients (7.9%)2NPPD appears to be a weak sensitizer compared to other hair dyes tested
- Executive summary:
A multicenter study was performed in 9 Italian centers by members of the GIRDCA' to evaluate the frequency and source of contact sensitization in a group of 302 hairdressers with dermatitis.Occupational habits and use of preventive measures were specifically investigated both in these 302 hairdressers. The results showed the presence of an occupationally relevant sensitization in 60.9% of the 302 hairdressers
Positive reactions to 2 NPPD occurred in 24 reactions (7.9%)
2NPPD appears to be a weak sensitizer compared to other hair dyes tested
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