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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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
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 chemical
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 chemical
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.