Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Body responsible for the test

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Body responsible for the test
IUPAC Name:
Body responsible for the test

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
other: 0.5 g of the test substance moistened with tap water and 2 to 3 drops of TWEEN 80 were applied to the intact skin and covered with a surgical gauze.
Controls:
not specified
Duration of treatment / exposure:
4h
Observation period:
no data
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
other: all animals
Score:
0
Reversibility:
no data
Irritation parameter:
edema score
Basis:
other: all animals
Score:
0
Reversibility:
no data

Any other information on results incl. tables

The 'Time points' at which the irritation parameters were determined cannot be provided because the NONS file (provided by ECHA) doesn`t contain this information

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: not specified
Conclusions:
The value of the scores for reythema and odema was 0 in all animals. The substance is not classified as irritating to the skin.