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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD GLP Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report date:
2007

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
GLP compliance:
yes
Type of study:
mouse local lymph node assay (LLNA)

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
female

Study design: in vivo (LLNA)

Vehicle:
other: ethyl acetete
Concentration:
10, 25, 50%
No. of animals per dose:
4

Results and discussion

In vivo (LLNA)

Results
Parameter:
SI
Remarks on result:
other: see Remark
Remarks:
A stimulation index of greater than 3 was recorded for the two higher concentrations of the test material (25% and 50% v/v in ethyl acetate). A stimulation index of less than 3 was recorded for the lowest concentration of the test material (10% v/v in ethyl acetate). The concentration of test material expected to produce a Stimulation Index of 3 is 19.9%.

Any other information on results incl. tables

There were no deaths. No signs of systemic toxicity were noted in the test or control animals

during the test. Fur loss around the ears and sticky, hardened residual test material were noted

post-dose on Day 2 and for the remainder of the test in animals treated with the test material at

concentrations of 25% and 50% v/v in ethyl acetate.

Bodyweight changes of the test animals between Day 1 and Day 6 were comparable to those

observed in the corresponding control group animals over the same period.

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material was considered to be a sensitiser under the conditions of the test.