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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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
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

Constituent 1
Reference substance name:
Body responsible for the test
IUPAC Name:
Body responsible for the test

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