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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
2017

Materials and methods

Principles of method if other than guideline:
Several literature articles were used for the assessment of skin sensitisation potential of the substance to humans.
GLP compliance:
no
Remarks:
some studies were conducted pre-GLP
Type of study:
other: skin sensitisation studies on humans
Justification for non-LLNA method:
An in vitro or in chemico skin sensitisation study does not need to be conducted because adequate data from different human studies is available.

Test material

Constituent 1
Reference substance name:
Lanolin, hydrogenated
EC Number:
232-452-1
EC Name:
Lanolin, hydrogenated
Cas Number:
8031-44-5
Molecular formula:
UVCB: not available
IUPAC Name:
Lanolin, wool wax, hydrogenated

In vivo test system

Test animals

Species:
other: human
Sex:
male/female

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Group:
test chemical
Remarks on result:
no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
other: not classified for skin sensitisation according to the CLP Regulation (EC) No.1272/2008
Conclusions:
The substance is not considered as a skin sensitiser to humans as the incidence of positive reactions is not substantial.
Executive summary:

The skin sensitisation of the substance and analogue substances (Similar Substance 01 and 02) to humans was assessed. Due to the use of the substances in cosmetics their skin sensitisation potential was evaluated in various human studies. Patients were subjected to patch test with the substances and the skin reactions were recorded and evaluated.

Positive skin reactions among the studies and analogue substances recorded varied from 1 - 4.4 %.

The substance is not considered as a skin sensitiser to humans as the incidence of positive reactions is not substantial.