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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
other information
Study period:
from June to July 1996
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Comparable to guideline study with acceptable restrictions: A combined study on acute dermal toxicity and on local tolerance was used to assess skin irritation/corrosion. The study design and reporting deviates from the current OECD TG 404, however, the study is considered sufficient for assessment of this endpoint.
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report date:
1996

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
- exposure time 24 hrs instead of 4 hrs, 6 animals instead of 3, few details in test description and reporting

Test material

Constituent 1
Chemical structure
Reference substance name:
(±)-13-ethyl-3-methoxygona-1,3,5(10),8-tetraen-17-one
EC Number:
227-699-7
EC Name:
(±)-13-ethyl-3-methoxygona-1,3,5(10),8-tetraen-17-one
Cas Number:
5941-92-4
Molecular formula:
C20H24O2
IUPAC Name:
13-ethyl-3-methoxy-6,7,11,12,13,14,15,16-octahydro-17H-cyclopenta[a]phenanthren-17-one (non-preferred name)
Test material form:
semi-solid (amorphous): gel
Remarks:
migrated information: paste

Test animals

Species:
rat
Strain:
other: Han:WST (SPF)

Test system

Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
other: 900 mg NaCl ad 100 ml bidist. water
Controls:
other: the untreated skin served as control
Amount / concentration applied:
218-240 mg/male animal or 192-214 mg/female animal
Duration of treatment / exposure:
24 hours
Observation period:
14 days
Number of animals:
3 males and 3 females

Results and discussion

Any other information on results incl. tables

No local intolerance reactions at the application sites were observed (no scores documented)

Applicant's summary and conclusion

Executive summary:

A combined study on acute dermal toxicity and on local tolerance was conducted . The study design and reporting deviates from the current OECD TG 404, however, the study was considered sufficient for assessment of skin irritation/corrosion.A single dermal administration of the test substance for 24 hours to male and female rats at a dose of 2000 mg/kg was tolerated without any local irritations.