Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
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:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
(25.02.1985)
Deviations:
not specified
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
other: rat, Tif:RAIf (SPF)
Strain:
other: F3-hybrid of RII 1/Tif x RII 2/Tif
Sex:
male/female

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
other: Distilled water containing 0.5% CMC and 0.1% polysorbate 80
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 male and 5 female animals per dose
Control animals:
not specified

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw

Any other information on results incl. tables

The animals recovered within 13 days.

Signs of toxicity related to dose levels used, time of onset and duration

Local: No treatment related signs of toxicity were observed.

Systemic: Dyspnea, ruffled fur, and abnormal body position were seen, being common symptomes in acute tests. Additonally, diarrhea was observed on day 1 after application.

Effects in organs: No deviations from normal morphology.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50 > 2000 mg/kg bw