Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Adequacy of study:
other information

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: OECD No.402 (1987) "Acute Dermal Toxicity" EC, Council Directive 67/548/EEC, Annex V, B.3 (1992) "Acute Toxicity (Dermal)" EPA, OPPTS 870.1200 (1998), "Acute Dermal Toxicity" JMAFF Guidelines (2000), including the most recent revisions.
GLP compliance:
yes
Limit test:
yes

Test animals

Species:
other: Rat, Wistar strain Crl:(WI)

Administration / exposure

Type of coverage:
occlusive
Vehicle:
other: Propylene glycol.
Duration of exposure:
24 h

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
Signs of toxicity related to dose levels:
Flat posture was noted in all animals on day 1.
Gross pathology:
Effects on organs:
No abnormalities were found at macroscopic post mortem
examination of the animals.
Other findings:
Signs of toxicity (local):
Chromodacryorrhoea was noted in one male on days 1 and 2.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU