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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Direct observations: clinical cases, poisoning incidents and other

Administrative data

Endpoint:
direct observations: clinical cases, poisoning incidents and other
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
disregarded due to major methodological deficiencies
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Original report not available and documentation insufficient for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report date:
1977

Materials and methods

Study type:
study with volunteers
Endpoint addressed:
skin irritation / corrosion
Principles of method if other than guideline:
In a Burckhardt test, a 5% solution of a soap formulation containing 0.2% of the test substance was applied 60 times within 30 minutes to the skin of 5 volunteers. The skin irritation effects were assessed during the exposure period.
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
95912-87-1 (5% dilution of a 0.2% formulation)
IUPAC Name:
95912-87-1 (5% dilution of a 0.2% formulation)
Details on test material:
- Name of test material (as cited in study report): only trade name given
- Analytical purity: no data

Method

Type of population:
general
Subjects:
- Number of subjects exposed: 5
Ethical approval:
not specified
Route of exposure:
dermal
Reason of exposure:
intentional
Exposure assessment:
not specified
Details on exposure:
A 0.01% solution of the test substance (5% solution of a soap formulation containing 0.2% of the test substance ) was applied 60 times within 30 minutes to the skin of 5 volunteers. The skin irritation effects were assessed during the exposure period.
Examinations:
- Other: skin irritation

Results and discussion

Results of examinations:
- Other: 1/5 volunteers reported a mild burning feeling at the application site of one test substance batch from 20 minutes after exposure started, and blotchy redness was observed until 1 hour after exposure ended. The remaining 4 subjects did not show any effects.

Applicant's summary and conclusion