Registration Dossier

Toxicological information

Skin sensitisation

Currently viewing:

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:
1992
Bibliographic source:
Contact Dermatitis. 1992 Feb; 26(2):101-7.

Materials and methods

Test guideline
Qualifier:
according to
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
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
Name of test material (as cited in study report): 2 nitro p phenylenediamine (2NPPD)Substance type: OrganicPhysical state: Solid

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 group
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