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Administrative data

Description of key information

The test item was evaluated for its sensitizing potential in Guinea Pigs. It was found to be non-sensitizing.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reason / purpose for cross-reference:
read-across source
Principles of method if other than guideline:
Not applicable.
Positive control results:
Not performed
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
undiluted
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no adverse findings
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: undiluted. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no adverse findings.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
undiluted
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no adverse findings
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: undiluted. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no adverse findings.
Key result
Group:
negative control
Remarks on result:
not measured/tested
Key result
Group:
positive control
Remarks on result:
not measured/tested
Interpretation of results:
GHS criteria not met
Conclusions:
The test material does not appear to be a sensitizer in the albino guinea pig.
Executive summary:

In a Magnusson-Kligman Guinea Pig maximization test, 20 Dunkin-Harley strain albino Guinea Pigs were treated with undiluted test substance, scores of zero in all test animals were obtained at all time points examined. The test material does not appear to be a sensitizer in the albino guinea pig.

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

The test item was evaluated for its sensitizing potential in Guinea Pigs. It was found to be non-sensitizing. The studies were found to be adequate to fufill the purposes of this endpoint.


Migrated from Short description of key information:
The test item is not skin-sensitizing to guinea pigs.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

no data available


Migrated from Short description of key information:
no data available

Justification for classification or non-classification

There are conclusive but not sufficient data for classification of the substance with regard to skin sensitization.

The test item is not classified for this endpoint in accordance to with the CLP Regulation (EC) No 1272/2008.

 

No data are available for respiratory sensitization.

The test item is therefore not classifiable for this endpoint in accordance to the CLP Regulation (EC) No 1272/2008.