Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018

Materials and methods

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

Test material

Constituent 1
Test material form:
liquid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Vehicle:
propylene glycol
Remarks:
80% Polyethylene glycol 400 (PEG 400) in distilled water
Duration of exposure:
15 days
Doses:
0, 500, 1000, 2000 mg/kg
No. of animals per sex per dose:
5
Control animals:
yes

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50 cut-off
Effect level:
> 2 000 mg/kg bw
Mortality:
Test-item related mortality was not observed in all male and female groups

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met