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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:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
Data is from peer-reviewed journal.

Data source

Reference
Reference Type:
publication
Title:
Allergic contact dermatitis from 2-chloro-p-phenylenediamine in a cream dye for eyelashes and eyebrows
Author:
Christer Hansson and Kirsten Thorneby-Andersson
Year:
2001
Bibliographic source:
Contact Dermatitis, 2001, 45, 235–236

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Allergic contact dermatitis from 2-chloro-p-phenylenediamine in a cream dye was evaluated on a 29- yr old woman.
GLP compliance:
not specified
Type of study:
not specified
Justification for non-LLNA method:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 2-chloro-p-phenylenediamine (2-chloro-PPD)
- Molecular formula (if other than submission substance): C6-H7-Cl-N2
- Molecular weight (if other than submission substance): 142.588 g/mole
- Substance type: Organic
- Physical state: Solid
- Purity: No data available
- Impurities (identity and concentrations): No data available
Specific details on test material used for the study:
- Name of test material (as cited in study report): 2-chloro-p-phenylenediamine (2-chloro-PPD)
- Molecular formula: C6-H7-Cl-N2
- Molecular weight: 142.588 g/mole
- Substance type: Organic
- Physical state: Solid
- Purity: No data available

In vivo test system

Test animals

Species:
other: humans
Strain:
not specified
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: No data available
- Age at study initiation: 29-year
- Weight at study initiation: No data available
- Housing: No data available
- Diet (e.g. ad libitum): No data available
- Water (e.g. ad libitum): No data available
- Acclimation period: No data available

ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data available
- Humidity (%):No data available
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light): No data available

IN-LIFE DATES: From: To: No data available


Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
1%
Challenge
Route:
other: no data
Vehicle:
petrolatum
Concentration / amount:
1%
No. of animals per dose:
1
Details on study design:
RANGE FINDING TESTS: No data available

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: Several years
- Exposure period: Several years
- Test groups: 1
- Control group: 10
- Site: lashes and brows.
- Frequency of applications: No data available
- Duration: Several years
- Concentrations: 1%

B. CHALLENGE EXPOSURE
- No. of exposures: No data available
- Day(s) of challenge: No data available
- Exposure period: No data available
- Test groups: No data available
- Control group: No data available
- Site: No data available
- Concentrations: No data available
- Evaluation (hr after challenge): No data available

OTHER: No data available
Challenge controls:
No data available
Positive control substance(s):
not specified

Results and discussion

Positive control results:
No data available

In vivo (non-LLNA)

Results
Reading:
1st reading
Group:
test group
Dose level:
1%
No. with + reactions:
1
Total no. in group:
1
Clinical observations:
Intensely itchy dermatitis at the brows were observed
Remarks on result:
positive indication of skin sensitisation

Any other information on results incl. tables

Table 1. PPD derivatives and metabolites tested (D3 readings)

Allergen

Concentration

Case no. 1

2-chloro-PPD

1%

+++

Cream dye

As is

++

Applicant's summary and conclusion

Interpretation of results:
other: Category 1 (skin sensitising) based on CLP criteria
Conclusions:
2-chloro-p-phenylenediamine (2-chloro-PPD) is skin sensitizing as a positive response is observed upon application to the brows of a 29 yr old lady.
Executive summary:

Allergic contact dermatitis from 2-chloro-p-phenylenediamine in a cream dye was evaluated on a 29- yr old woman. She had used the same product for several years without any side-effects. The colour was semipermanent and applied only 4X a year. She had developed an intensely itchy dermatitis at her brows but not at her lashes, despite these having been coloured at the same time. After treatment with corticosteroids, the dermatitis disappeared within a week.

 

The case was patch tested with the European standard series and PPD derivatives used for hair colouring, as well as their own cream dyes and constitu ents, including chloro-PPD. At D3, she had a +++ reaction to chloro-PPD (1% pet.) and a ++reaction to the cream dye as is. She also had a + reaction to PPD but no reaction to the other derivatives or metabolites of PPD tested.

 

No further positive reactions were found at D7. 10 controls were negative to the chloro-PPD test.

 

According to the publication, the test material classifies as a skin sensitizer.