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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
other: 84/449/EEC,B.6 (guinea pig maximization test (GPMT))
GLP compliance:
yes
Type of study:
other: guinea pig maximizaton test(GMPT)
Species:
other: gpg, Pirbright White
Concentration / amount:
Concentration of test material and vehicle used at induction:
a) intradennally: 5 % in sesame oil
b) epidennally: 100% in sesame oil
Concentration of test material and vehicle used for each challenge:
a) 30 % in Vaseline
Concentration / amount:
Concentration of test material and vehicle used at induction:
a) intradennally: 5 % in sesame oil
b) epidennally: 100% in sesame oil
Concentration of test material and vehicle used for each challenge:
a) 30 % in Vaseline
No. of animals per dose:
Number of animals in test group: 20
Number of animals in negative control group: 10
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
30%
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: 30%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
30%
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: 30%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
30%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 30%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
30%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 30%. No with. + reactions: 0.0. Total no. in groups: 10.0.

Maximum concentration not causing irritating effects in preliminary test: 30 %

Signs of irritation during induction: None

Evidence of sensitisation of each challenge concentration:None

Interpretation of results:
other: not classified
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Two skin sensitisation studies in the guinea pig (guinea pig maximisation test, GPMT) were available. In the supporting study (Annex V, GLP), adult guinea pigs ((Pirbright White); 20 test animals in test group, 10 animals in control group) were induced by applications of the test substance: 5% seasame oil (intradermal) and 100% seasame oil (topical). The concentration of test material and vehicle used for each challenge was 30% in vaseline. No positive response was observed upon challenge in test or control animals.

The study chosen as a key study was a GPMT conducted according to 84/449/EEC B.6/GLP. The maximum concentration not causing irritating effects in a preliminary test was 30%. In the key study, adult guinea pigs ((Pirbright White); 20 test animals in test group, 10 animals in control group) were induced by applications of the test substance: 5% seasame oil (intradermal) and 100% seasame oil (topical). The concentration of test material and vehicle used for each challenge was 30% in vaseline. At 100%, erythema occurred at the edge of the exposure surfaces, 30% was the highest non-irritant concentration. No positive response was observed upon challenge in test or control animals.

The results from both tests indicate a sensitization rate of 0%. The substance can be classified as non-sensitising in albino guinea pigs.


Migrated from Short description of key information:
Not sensitising (84/449/EEC,B.6, Guinea pig maximisation test; GLP)

Justification for selection of skin sensitisation endpoint:
There is more information provided in the results of the key study

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the available information in the dossier, the substance Chiguard 5599 (CAS No. 127519-17-9) does not need to be classified for skin sensitisation when considering the criteria outlined in the CLP Regulation (Annex I of 1272/2008/EC) and Annex I of Regulation 286/2011/EC.