Registration Dossier

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
other: U.S. 52 FR 42961, 49 CFR 173.132
Principles of method if other than guideline:
This study was performed under the DOT guidelines specified in 52 FR 42961, 49 CFR 173.132
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
Yellowish Brown Liquid, Lot # 00312AB, no purity given

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
Albino rats, five males and five females
All weighed between 200 and 300g

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
All rats were administered a single Sponsor specified dose of the test substance by oral gavage.
Doses:
500 mg/kg bw
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
All animals received a single dose of 500 mg/kg bw of the test substance by oral gavage. The dose volume did not exceed 1 ml/100 g body weight. Following treatment, the animals were observed for clinical signs of toxicity at least once daily for 14 days. Body weights were determined on Day 0, Day 7, and Day 14.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 500 mg/kg bw
Based on:
test mat.
Mortality:
1 rat died on Day 2 of the observation period.
Clinical signs:
Two of the test animals exhibited clinical signs
Body weight:
All surviving animals exhibited body weight gain by day 14
Gross pathology:
The animal that died during the study was observed at necropsy as having a moderately pale liver. All other animals were observed as having no visible lesions at necropsy

Any other information on results incl. tables

The oral LD50 of the test material is ≥500 mg/kg bw according to a U.S. DOT guideline study.

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Remarks:
> 300 mg/kg as per Regulation EC No. 1272/2008
Conclusions:
The oral LD50 of the test material is greater than 500 mg/kg bw in rats.