Registration Dossier

Administrative data

Description of key information

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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: A study summary was made available by ECHA under Article 25, Para 3., of EC Regulation 1907/2006.
Reference:
Composition 0
Qualifier:
according to
Guideline:
other: Annex V
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Test material information:
Composition 1
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
not specified
Route:
intradermal and epicutaneous
Vehicle:
arachis oil
Concentration / amount:
Intradermal induction: 0.5% (w/v)
Topical induction: 25% (w/v)
Route:
epicutaneous, occlusive
Vehicle:
arachis oil
Concentration / amount:
Intradermal induction: 0.5% (w/v)
Topical induction: 25% (w/v)
No. of animals per dose:
10 test animals
5 vehicle control animals
Challenge controls:
5 and 10% (w/v)
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
10%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
5%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
10%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
5%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
10%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
5%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
10%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
5%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 5.0.

Maximum concentration not causing irritation effects: 10% (w/v)

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
There was no dermal response to challenge concentrations of 5% or 10% (w/v) of the test substance. The substance was not classified for skin sensitisation according to CLP criteria.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

The substance was tested in two GLP studies (Pharmakon Europe,1993 and Safepharm Laboratories,1998) in absolute ethanol or arachis oil, respectively, using the guinea–pig Magnusson & Kligman Maximisation Test, with single intradermal (0.1% w/w or 0.5% w/w respectively) and topical (0.1% w/w or 25% w/w respectively) induction administrations one week apart, and a single challenge application (50% w/w or 5 and 10% w/w respectively) two weeks later. There were no positive reactions observed to challenge with the test material in any test or vehicle control animal.

 


Migrated from Short description of key information:
The substance caused no skin sensitisation response in the guinea-pig maximisation test using EEC Annex V test methods

Justification for selection of skin sensitisation endpoint:
Higher induction concentrations of the two available studies, and the vehicle appears to be more appropriate.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

No study data are available for respiratory sensitisation. In the absence of skin sensitisation, respiratory sensitisation is not expected to occur. .

 

Justification for classification or non-classification

The available animal test data are reliable and suitable for classification purposes under regulation 1272/2008. The substance is not therefore classified for skin sensitisation under EU CLP criteria.