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Diss Factsheets

Administrative data

Description of key information

With the Buehler test method, the guinea pigs treated with the test substance showed no skin sensitisation.

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Qualifier:
according to guideline
Guideline:
other: Chinese standard HJ/T154-2004
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
The in vivo skin sensitisation study was carried out before 10 May 2017, and meets the requirements set out in Article 13(3), first subparagraph, and Article 13(4) and is considered appropriate to address this standard information requirement.
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot number of test material: manufacturer, 100315
Species:
guinea pig
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 10 weeks old
- Weight at study initiation: 224 - 291 g
- Housing: 4 animals in a cage, in total 8 cages; plastic breed box (L35 x W50 x H32 cm), four in a cage, cage changed twice a week.
- Diet: During the whole period, the animals are free to eat.
- Water: During the whole period, the animals are free to drink.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 48 - 56
- Photoperiod (hrs dark / hrs light): 12/12, lighting simulates natural sunlight
No. of animals per dose:
Each test group has 16 animals: one negative control group and one experimental group.
Details on study design:
Induction contact:
Fur on one side of the back is shaved off 24 hr before testing, the area is 3 x 3 cm2.
0.2g of the sample is painted on a 2 x 2 cm2 filter paper, then placed on the exposed skin rinsed with distilled water, then cover with 2 layers of guaze fabric and a layer of oil paper, and fixed with non-irritating tape, in order to let the test sample to have good contact with the skin, and avoid animal licking. Treatment time is 6 hr.
Observe skin reaction at 1hr and 24 hr. Repeat the same method on the 7th and 14th day.

Challenge contact:
Fur on the other side of the animal is shaved off, the area is 3 x 3 cm2.
14 days after the last contact, 0.2g of the sample is painted on a 2 x 2 cm2 filter paper, and pasted on the exposed skin area with the same method for 6 hr. After removing the attached sample, record skin reaction everyday at 24hr, 48hr. Negative control and positive control are repeated with the same experimental method.
Use the number of animals with erythema or skin swelling at 24 hr, 48 hr and divide with the total number of animals, to calculate the sensitization ratio and categorise the sensitisation level and grade the acute skin sensitisation toxicity.
Positive control substance(s):
yes
Remarks:
0.5% 2,4-dinitrochlorobenzene
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.2 g of the sample
No. with + reactions:
0
Total no. in group:
16
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.2 g of the sample
No. with + reactions:
0
Total no. in group:
16
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
16
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
16
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
0.5% 2,4-dinitrochlorobenzene
No. with + reactions:
16
Total no. in group:
16
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
0.5% 2,4-dinitrochlorobenzene
No. with + reactions:
16
Total no. in group:
16
Remarks on result:
positive indication of skin sensitisation
Interpretation of results:
GHS criteria not met
Conclusions:
Using the Buehler test method, the guinea pigs treated with the test substance showed no skin sensitisation.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Justification for classification or non-classification