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:
1 (reliable without restriction)
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
not specified
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
valid test according to official guideline
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
not specified
Concentration / amount:
Concentration of test material and vehicle used at induction:
1% in vaseline oil for the intradermal injection.
100% for the booster
Concentration of test material and vehicle used for each challenge:
75% in vaseline oil
Concentration / amount:
Concentration of test material and vehicle used at induction:
1% in vaseline oil for the intradermal injection.
100% for the booster
Concentration of test material and vehicle used for each challenge:
75% in vaseline oil
No. of animals per dose:
Number of animals in test group: 10
Number of animals in negative control group: 5
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
75%
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: 75%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
75%
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: 75%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
75%
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: 75%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
75%
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: 75%. No with. + reactions: 0.0. Total no. in groups: 5.0.

Evidence of sensitisation of each challenge concentration: No animals showed positive reactions at the challenge.

Other observations: The injection of the test article at the concentration of 1% in the vehicle caused slight irritation ( slight erythema and edema). Twenty-four hours after the removal of the 48-hour closed patch (booster), signs of slight irritation such as slight erythema of the skin were observed in animals treated with the test substance.

Interpretation of results:
other: not classified
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:
Migrated from Short description of key information:
The substance is not sensitiser.

Justification for selection of skin sensitisation endpoint:
Study conducted according to internationally accepted guideline.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the Regulation EC n. 1272/2008 skin sensitizer means a substance that will lead to an allergenic response following skin contact. RZ 97 is not capable to induce allergic reaction, therefore no classification is warranted.