1,3-isobenzofurandione, reaction products with methylquinoline and quinoline

Endpoint summary

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

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 chemical

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”.