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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The study was conducted in compliance with GLP standards according to Guideline 84/449/EWG, B.6 and OECD 406 (1981). However, full study report is not available as the data is > 12 year old and summaries have been prepared using data provided by ECHA.
Qualifier:
according to guideline
Guideline:
other: 84/449/EG, B.6, OECD Guideline 406 (1981)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Species:
guinea pig
Strain:
other: Pirbright-White Hoe: DHPK (SPF Lac)
Concentration / amount:
Concentration of test material and vehicle used at induction:
i.c.: 1% in 50 % FCA Paraffin
p.c.: 25% in Vaseline

Concentration of test material and vehicle used for each challenge:
p.c.: 25% in Vaseline
Concentration / amount:
Concentration of test material and vehicle used at induction:
i.c.: 1% in 50 % FCA Paraffin
p.c.: 25% in Vaseline

Concentration of test material and vehicle used for each challenge:
p.c.: 25% in Vaseline
No. of animals per dose:
Number of animals in test group: 10
Number of animals in negative control group: 5
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
25 %
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: 25 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0 %
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: 0 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
The study was carried out in compliance with GLP according to guideline 84/449/EG, B.6 and OECD 406. The substance is non-sensitizing in nature.
Executive summary:

The sensitisation potential of the test substance was investigated in a guinea pig maximisation study. 10 animals were induced with test material, 5 animals with vehicle. There were no signs of toxicity observed in any animal. No sensitization was observed in animals in this study. The result of this study is used as a key value for hazard assessment and classification and labelling.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

The sensitization potential of the test substance was investigated in a guinea pig maximisation study (84/449/EG, B.6, OECD Guideline 406 (1981)) with acceptable restrictions (no data on measurements and calculations). 15 guinea pigs of unspecified sex were induced, 10 animals with test material, 5 animals with vehicle. Concentration of the test material and vehicle used at induction: 1 % test item in 50 % FCA Paraffin p.c.: 25% test item in Vaseline. Concentration of the test material and vehicle used for each challenge: p.c.: 25% in Vaseline. There were no signs of toxicity observed in any animal. One animal died during the study but it is evaluated that death is not due to the substance.

No sensitization was observed in animals in this study. This study is considered reliable satisfying the guideline requirements for the skin sensitization study. The result of this study is used as a key value for hazard assessment and classification and labeling.


Migrated from Short description of key information:
Guinea pig maximisation test (OECD 406): negative

Justification for selection of skin sensitisation endpoint:
The guideline compliant study.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The test substance is not classified for skin sensitization according to the CLP Regulation No. 1272/2008 and as R43 according to EU Directive 67/548/EEC.