Registration Dossier

Administrative data

Description of key information

Skin sensitisation (in vivo): Not sensitising (84/449/EWG, B.6/GLP)

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:
other: Guideline study, GLP compliance
Qualifier:
according to guideline
Guideline:
other: 84/449/EWG, B.6(MeerschwelnchElO-Maxlmlerungstest (GPMT)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The study was conducted in 1991, when the GPMT was the internationally accepted and recomme
nded study type in order to assess sensitizing potential of a substance.
Species:
guinea pig
Strain:
other: Pirbright White Tif:DHP
Sex:
male/female
Concentration / amount:
Concentration of test material and vehicle used at Induction:
a) Intradermal: 5% In sesame oil
b) Epidermal: 30% in vaseline
Concentration / amount:
Concentration of test material and vehicle used for each challenge:
a) 10% In vaseline
No. of animals per dose:
Number of animals In testgroup: 20
Number of animals In negative control group: 20
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
10%
No. with + reactions:
0
Total no. in group:
20
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: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10%
No. with + reactions:
0
Total no. in group:
20
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: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
10%
No. with + reactions:
0
Total no. in group:
20
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: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
10%
No. with + reactions:
0
Total no. in group:
20
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: 20.0.
Reading:
other: Positive Control data not available
Group:
positive control
Dose level:
Positive Control data not available
Remarks on result:
not measured/tested
Interpretation of results:
other: not classified
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

Skin sensitisation (in vivo):

There are no in vitro skin sensitisation studies available. There is one in vivo GPMT available.

In a dermal sensitization study (84/449/EWG, B.6/GLP) with the substance in vaseline/sesame oil, Pirbright White Tif:DHP guinea pigs (20/group) were tested in a maximisation test. For induction, 5% w/v in sesame oil (intradermal injections) and 30% w/v in vaseline (topical application) was used. For challenge, 10% w/ in vaseline was used for topical application. The evaluation of skin reactions after challenge was carried out at 24 and 48 hrs. The maximum concentration not causing irritating effects in the preliminary test was 30 %. Pre-treatment with 10% sodium lauryl sulphate prior to the dermal induction treatment was carried out. There were no signs of irritation during induction. There was no evidence of sensitisation at the challenge concentration in all groups (test and control). Based on these results, the substance is not sensitising.

Justification for classification or non-classification

Based on the available information in the dossier, the substance does not need to classified for skin sensitisation when the criteria outlined in Annex I of 1272/2008/EC and Annex I of 286/2011/EC are applied.