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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Endpoint summary

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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)
Rationale for reliability incl. deficiencies:
other: Information from migrated NONS file, as per inquiry number 06-2120053135-66-0000, permission to refer granted by ECHA
Qualifier:
according to guideline
Guideline:
other: Annex V (Maximisation test)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Information from migrated NONS file
Species:
guinea pig
Concentration / amount:
Concentration of test material and vehicle used at induction:
a) 0.5% v/v in acetone containing 5% w/v alembicol D
b) Undiluted
Concentration of test material and vehicle used for each challenge:
20% and 50% v/v in acetone
Concentration / amount:
Concentration of test material and vehicle used at induction:
a) 0.5% v/v in acetone containing 5% w/v alembicol D
b) Undiluted
Concentration of test material and vehicle used for each challenge:
20% and 50% v/v in acetone
No. of animals per dose:
Number of animals in test group: 20
Number of animals in negative control group: 20
Positive control results:
Evidence of sensitisation of each challenge concentration: Evidence of sensitisation was observed in 3 animals.
Key result
Reading:
other: Not available - summary provided by ECHA 2014
Group:
test chemical
Dose level:
20% and 50%
No. with + reactions:
3
Total no. in group:
20
Clinical observations:
Evidence of sensitization at each concentration.
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
other: Not available - summary provided by ECHA 2014
Group:
negative control
Dose level:
20% and 50% v/v
Total no. in group:
20
Clinical observations:
Not available - summary provided by ECHA 2014
Remarks on result:
other: Not available - summary provided by ECHA 2014
Key result
Reading:
other: Not available - summary provided by ECHA 2014
Group:
positive control
Dose level:
Not available - summary provided by ECHA 2014
Clinical observations:
Not available - summary provided by ECHA 2014
Remarks on result:
other: Not available - summary provided by ECHA 2014

Evidence of sensitisation of each challenge concentration: Evidence of sensitisation was observed in 3 animals.

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

Justification for classification or non-classification