Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
27 November 2008 - 11 Dec3ember 2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study; well documented study report

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): OS238132
- Physical state: tan colored solid
- Storage condition of test material: room temperature in the dark

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
arachis oil
Control animals:
not required

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
mg/kg bw
Mortality:
There were no deaths
Clinical signs:
There were no signs of systemic toxicity
Body weight:
Animals showed expected gains in bodyweight over the study period, except for two females which showed bodyweight loss or no gain in bodyweight during the first week but expected gain in bodyweight during the second week
Gross pathology:
No abnormalities were noted at necropsy.

Any other information on results incl. tables

The acute dermal median lethal dose (LD50)of the test material in the Wistar strain rat was found to be greater than 2000 mg/kg bodyweight.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: not specified
Conclusions:
The acute dermal median lethal dose (LD50) of the test material in the Wistar strain rat was found to be greater than 2000 mg/kg bodyweight.
Executive summary:

The study was performed to assess the acutedermal toxicity of the testmaterial in the Wistar strain rat according to OECD Guideline 402 and Method B3 Acute Toxicity (Dermal) of Commission Directive 92/69/EEC. A group of ten animals(fivemales and five females) was given a single, 24-hour, semi-occluded dermal application of the test material to intact skin at a dose level of 2000 mglkg bodyweight. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy. There were no deaths,no signs of systemic toxicity, andno signs of dermal irritation. Animals showed expected gains in body weight over the study period, except for two females which showed body weight loss or no gain in body weight during the first week but expected gain in body weight during the second week. No abnormalities were noted at necropsy. The acutedermal median lethal dose (LD50)of the test material in theWistar strain rat was found to be greater than 2000 mg/kg bodyweight.