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Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Data is from peer reviewed journal
Qualifier:
according to
Guideline:
other: Data is from Journal with permission
Principles of method if other than guideline:
An irritation profiling was performed to determine thresholds for irritation
GLP compliance:
not specified
Type of study:
other: Modified Buehler test
Justification for non-LLNA method:
not specified
Species:
guinea pig
Strain:
Hartley
Sex:
female
Details on test animals and environmental conditions:
- Source: No data
- Age at study initiation: No data
- Weight at study initiation: 300-500g
- Housing: 5 per cage
- Diet : ad libitum
- Water: ad libitum
- Acclimation period: No data
Route:
epicutaneous, occlusive
Vehicle:
other: ethanol
Concentration / amount:
95% ethanol
Route:
epicutaneous, occlusive
Vehicle:
other: ethanol
Concentration / amount:
95% ethanol
No. of animals per dose:
Total animals-13
Details on study design:
RANGE FINDING TESTS: No data available

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3 (Once weekly for 3 consecutive weeks)
- Exposure period: 24hr
- Test groups: 13
- Control group: 13, Concurrent
- Site: Nuchal area
- Frequency of applications: Once weekly
- Duration: 3 consecutive weeks
- Concentrations: 50%

B. CHALLENGE EXPOSURE
- No. of exposures: No data available
- Day(s) of challenge: No data available
- Exposure period: 24hr
- Test groups: 13
- Control group: 13, Concurrent
- Site: No data available
- Concentrations: 1.0, 3.0, 10.0%
- Evaluation (hr after challenge): after 24 hrs rest period

OTHER: One-tailed Mann-Whitney U Statistic (α₌ 0.05) was used to test for statistically significant differences between the scores in the test and vehicle control groups.
Positive control substance(s):
not specified
Positive control results:
All skin responses in control animals were of low order.
Reading:
other: Sensitizing
Hours after challenge:
24
Group:
test group
Dose level:
10.00%
No. with + reactions:
11
Total no. in group:
13
Clinical observations:
Mild erythema, usually confluent (barely perceptible)
Remarks on result:
other: Reading: other: Sensitizing. . Hours after challenge: 24.0. Group: test group. Dose level: 10.00%. No with. + reactions: 11.0. Total no. in groups: 13.0. Clinical observations: Mild erythema, usually confluent (barely perceptible).

Frequency of skin sensitization responses in the guinea pig.

Animals group

    D & C Yellow

1%

3%

10%

Test

4/13

6/13

11/13

Vehicle control

3/13

2/13

2/13

Interpretation of results:
other: Weakly Sensitizing
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The test compound D &C yellow no. 11 induced delayed type skin sensitization in guinea pig and is found to be a sensitizing to the skin of guinea pigs.
Executive summary:

Modified Buehler test was performed to study the sensitizing potential ofD &C yellow no. 11 to the skin of Guinea pigs.

The induction phase was accomplished with 24 hr occluded patch in nuchal area once weekly for three consecutive weeks following 2 week resting period. Pigs were initially challenged with dye used during the induction phase and then with the concentration of 1.0, 3.0 and 10%.Thereafter the patches were removed and the guinea pigs were rested for 24 hrs depilated with a chemical depilatory and evaluated and scored for erythema and edema.

D &C yellow no. 11 at a challenge concentration of 10% elicited delayed skin sensitization in 11 of 13 animals and hence is a weak sensitizer. Lower concentrations did not elicit statistically significant response.

According to the publication, the test material is a skin sensitizer.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

Skin sensatization:-

Based on the studies available with Klimish rating 2 for the target substances CAS: 8003-22-3 the results is summarized as follows:

Sr.No

Endpoint

Effect

Species

Sources

1

Skin Sensitisation

Weakly Sensitizing

guinea pig

Data from publication for CAS: 8003-22-3

2

Skin Sensitisation

sensitising

Human

Data from publication for CAS: 8003-22-3

3

Skin Sensitisation

sensitising

Human

Data from publication for CAS: 8003-22-3

 

 By applying weight of evidence approach, it can be concluded that the substance is sensitizing to the skin of guinea pig and human.

Migrated from Short description of key information:

D & C yellow elicit skin sentisitization in 11 of 13 animals at challenge concentration. The study elicit D&C yellow no. 11 induced delayed type skin sensitization in guinea pig was scored  as 1 i.e. Mild erythema, usually confluent (barely perceptible) and required a concentration of 10% for elicitation.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The chemical D&C Yellow No. 11 is likely to be "sensitizing" to the skin of guinea pig and human as per the available experimental data. Thus, the chemical is classified as being "sensitizing”.