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Description of key information

In a skin sensitization test (BASF, 1959), tt was concluded that the test substance is a skin sensitizer.

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:
1959
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
according to guideline
Guideline:
other: Guinea Pig patch test
Principles of method if other than guideline:
Areas (ca. 25 cm2) on the right and left flank of the guinea pig are shaved and then greased. After 24 hours, the left flank is degreased with ether. A total of ca. 0.1 ml of the test material (20 % solution in acetone) is then applied in three consecutive applications. This application is repeated daily for 10 days, if necessary with larger amounts, until clear signs of irritation are observed on the treated skin area. Treatment is then discontinued until the signs of irritation have subsided (11 days). Both the left and right flank is then shaved again. The previosuly untreated right flank is then degreased with ether 24 hours later and treated once with a 2 % solution (in acetone) of the test substance. The skin reaction is scored 8, 12 and 24 hours after application.
GLP compliance:
no
Type of study:
patch test
Justification for non-LLNA method:
Historical, In vivo study which was conducted before 1st June 2008
Species:
guinea pig
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
no data
Route:
epicutaneous, open
Vehicle:
other: acetone
Concentration / amount:
20% test substance in acetone
Day(s)/duration:
10
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Route:
epicutaneous, open
Vehicle:
other: acetone
Concentration / amount:
2% test substance in acetone
Day(s)/duration:
10
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
10
Details on study design:
Areas (ca. 25 cm2) on the right and left flank of the guinea pig are shaved and then greased. After 24 hours, the left flank is degreased with ether. A total of ca. 0.1 ml of the test material (20 % solution in acetone) is then applied in three consecutive applications. This application is repeated daily for 10 days, if necessary with larger amounts, until clear signs of irritation are observed on the treated skin area. Treatment is then discontinued until the signs of irritation have subsided (11 days). Both the left and right flank is then shaved again. The previosuly untreated right flank is then degreased with ether 24 hours later and treated once with a 2 % solution (in acetone) of the test substance. The skin reaction is scored 8, 12 and 24 hours after application.
Challenge controls:
no data
Positive control substance(s):
not specified
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
2 %
No. with + reactions:
9
Total no. in group:
10
Clinical observations:
erythema
Remarks on result:
positive indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
2 %
No. with + reactions:
0
Total no. in group:
3
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Group:
positive control
Remarks on result:
not measured/tested
Interpretation of results:
sensitising
Remarks:
Migrated information
Conclusions:
Based on the available data, the test substance is considered a Skin sensitiser according to Regulation (EC) No 1272/2008 (CLP).
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

In a skin sensitization test (BASF, 1959), areas (ca. 25 cm2) on the right and left flank of ten guinea pig are shaved and then greased. After 24 hours, the left flank is degreased with ether. A total of ca. 0.1 ml of the test material (20 % solution in acetone) is then applied in three consecutive applications. This application is repeated daily for 10 days, if necessary with larger amounts, until clear signs of irritation are observed on the treated skin area. Treatment is then discontinued until the signs of irritation have subsided (11 days). Both the left and right flank is then shaved again. The previosuly untreated right flank is then degreased with ether 24 hours later and treated once with a 2 % solution (in acetone) of the test substance. The skin reaction is scored 8, 12 and 24 hours after application. In addition, three control animals are also challenged in a similar manner. 9 out of 10 guinea pigs displayed erythema, whereas none of the control animals showed any signs of irritation. It was therefore concluded that the test substance is a skin sensitizer.

In a skin sensitization test (BASF, 1967), areas (ca. 25 cm2) on the right and left flank of ten guinea pig are shaved and then greased. After 4 hours, the left flank is degreased with ether. The test material (20 % solution in acetone) is then applied in three consecutive applications. This application is repeated daily for 10 days (5 days/week), if necessary with larger amounts, until clear signs of irritation are observed on the treated skin area. Treatment is then discontinued until the signs of irritation have subsided (13 days). Both the left and right flank is then shaved again. The previosuly untreated right flank is then degreased with ether 4 hours later and treated once with a 2 % solution (in acetone) of the test substance. The skin reaction is scored 12 hours after application. In addition, three control animals are also challenged in a similar manner. 10 out of 10 guinea pigs displayed erythema, whereas none of the control animals showed any signs of irritation. It was therefore concluded that the test substance is a skin sensitizer.

Further available limited data in guinea pigs (TSCAT, OTS0571642) also showed that the test substance is a skin sensitizer.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

According to the findings of the available studies, the test substance has to be classified as Skin sensitisation Cat. 1 (CLP). A subcategorization into 1A and 1B is not possible based on the available data.

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