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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
other:
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): C-SAT 080029
- Physical state: liquid
- Analytical purity oder Active matter: 99.1%
- Lot/batch No.: CE72530027

Test animals

Species:
rat
Strain:
other: CD/Crl:CD (SD)
Sex:
male/female

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
not required

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD0
Effect level:
>= 2 000 mg/kg bw
Mortality:
none
Clinical signs:
no changes
Body weight:
no changes
Gross pathology:
no changes
Other findings:
no

Any other information on results incl. tables

LD0>2000 mg/kg

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
substance not toxic after dermal application
Executive summary:

The study was performed as a limit test according to OECD guideline 402. Wistar rats (5 males and 5 females) were randomly selected for the study. The group was exposed to a single dermal dose of 2000 mg/kg b.w. for 24 hours followed by an observation period of 14 days. During the study clinical signs of reaction to the treatment were recorded daily. Body weight was recorded once a week. After the two-week observation period the animals were killed and subjected to a gross necropsy examination. All animals survived the application and did not reveal any signs of toxicity. The animals gained the expected body weight. No skin reactions at the application site were observed. No macroscopic findings were observed at necropsy. These results indicate that the test substance has no significant toxic effect in the rat following dermal administration of a single dose at a level of 2000 mg/kg.