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Diss Factsheets

Administrative data

Description of key information

Skin sensitisation

Under the conditions of the study, the test material is not considered to be a skin sensitiser.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
07 August 2009 to 20 October 2009
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
other: the Guidelines for the Testing of Chemicals
Deviations:
no
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
not specified
Remarks:
Not specified
Type of study:
Buehler test
Justification for non-LLNA method:
Study conducted prior to adoption of LLNA guideline by the OECD.
Species:
guinea pig
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20 to 24°C
- Humidity: 50 to 70%
Route:
epicutaneous, semiocclusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
0.12 g
Day(s)/duration:
6 hour application on day 1, day 7 and day 14
Adequacy of induction:
not specified
No.:
#1
Route:
epicutaneous, semiocclusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
0.1 g
Day(s)/duration:
6 hour application on day 28
Adequacy of challenge:
not specified
No. of animals per dose:
10 animals in the control group and 10 animals in the treatment group.
Details on study design:
A. INDUCTION EXPOSURE
At least 24 hours prior to application of the test material, the hair on the left back was shaved closely with electric clippers for area of 3 x 3 cm^2. 0.12 g of the test material was smeared on a 2 x 2 cm^2 filter paper and applied to the shaved part of the animal. The application sites were covered with two layers of gauze and a layer of polyethylene sheet and then covered with adhesive tape. Animals were returned to their cages for observation. After 6 hours, the coverings were removed and the application sites were rinsed completely with warm water. On the 7th and 14th day, the guinea pigs were induced by the same method. 0.12 mL oil was used in negative group in this study.

B. CHALLENGE EXPOSURE
14 days after the last induction exposure, the animals were challenged. 24 hours before application of the test material, the hair on the back was shaved closely with electric clippers for an area of 2 x 2 cm^2. 0.1 g of the test material, which was confected in the same way as the induction application, was applied to the animals following the same method. Animals were returned to their cages for observation. After 6 hours, coverings were removed and the application sites were rinsed completely with warm water. The observations continued for 48 hours. 0.1 g of the test material was used in negative group in this study.

OBSERVATIONS
1 and 24 hours after the inductive exposure and 24 and 48 hours after challenge exposure, the reaction intensity was evaluated and the number of guinea pigs that appeared to show erythema or oedema was counted. The rate was divided by the total counted number of animals and the rate of allergy was calculated.
Challenge controls:
0.1 g of test material.
Positive control substance(s):
no
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.1 g
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.1 g
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0.1 g
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0.1 g
No. with + reactions:
0
Total no. in group:
10
Reading:
1st reading
Group:
positive control
Remarks on result:
not measured/tested

No erythema or oedema appeared in the period of observation and the rate of allergy was 0. Body weights increased as expected throughout the course of the study.

Interpretation of results:
other: Not sensitising in accordance with EU criteria
Conclusions:
Under the conditions of the study, the test material is not considered to be a skin sensitiser.
Executive summary:

The skin sensitisation potential of the test material was investigated using guinea pigs in accordance with the Guidelines for the Testing of Chemicals, using the Buehler test. The animals were inducted three times with 0.12 g of test material on the left side of the back on days 0, 7, and 14. Fourteen days after the last induction exposure, the animals were challenged with 0.1 g of the test material on the right side of the back. One and 24 hours after the inductive exposure and 24 and 48 hours after challenge exposure, the reaction intensity (erythema and oedema appearance) was evaluated and the number of animals that appeared to show erythema or oedema was counted. The rate was divided by the total counted number of animals and the rate of allergy was calculated. Results showed that the rate of allergy was 0. Under the conditions of the study, the test material is not considered to be a skin sensitiser.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

The skin sensitisation potential of the test material was investigated using guinea pigs in accordance with the Guidelines for the Testing of Chemicals, using the Buehler test. The animals were inducted three times with 0.12 g of test material on the left side of the back on days 0, 7, and 14. Fourteen days after the last induction exposure, the animals were challenged with 0.1 g of the test material on the right side of the back. One and 24 hours after the inductive exposure and 24 and 48 hours after challenge exposure, the reaction intensity (erythema and oedema appearance) was evaluated and the number of animals that appeared to show erythema or oedema was counted. The rate was divided by the total counted number of animals and the rate of allergy was calculated. Results showed that the rate of allergy was 0. Under the conditions of the study, the test material is not considered to be a skin sensitiser.

Justification for classification or non-classification

In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No 1272/2008, the substance does not require classification with respect to skin sensitisation.