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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

The substance was not considered to be sensitizing to the skin.

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:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Currently no LLNA study is available for assessment. The Guinea Pig Maximization Test (GPMT) has been carried out as an animal test to predict human sensitization for over a decade and is recommended by international test guidelines such as OECD.
Species:
guinea pig
Strain:
not specified
Sex:
not specified
Route:
intradermal and epicutaneous
Vehicle:
unchanged (no vehicle)
Route:
intradermal and epicutaneous
Vehicle:
unchanged (no vehicle)
Day(s)/duration:
24 h
Details on study design:
Induction was by intradermal injection of the test substance, followed after 7 days by an epicutaneous application.
After a 14 day rest period epicutaneous challenge doses were applied for 24 h and the site inspected for signs of irritation at 24 and 48 h after removal of the challenge patch.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
no data
No. with + reactions:
0
Total no. in group:
0
Interpretation of results:
GHS criteria not met
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

No assessable information regarding skin sensitization in animals is available.

In poorly described publications, Ballantyne and Snellings (2007) as well as EPA (1979) found no skin-sensitizing properties (guinea pig maximization test and human patch test).

The test substance was tested to determine its ability to sensitize the skin of normal volunteer subjects using occlusive and semi-occlusive repeated insult patch tests. Three-hundred-ninetyseven (397) subjects completed the study. Under the conditions employed in this study, there was no evidence of sensitization ( TKL Research Inc., 1989)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the available information classification for skin sensitisation is not warranted in accordance with EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008.