Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
no data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data are given, equivalent or similar to OECD guideline.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
Principles of method if other than guideline:
BASF-Test.
In principle, the methods described in OCED guideline 401 were used.
GLP compliance:
no
Remarks:
pre-GLP study
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
liquid: viscous

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
male and female rats
- Age at study initiation: young adult, no further data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
distilled water
- Concentration in vehicle: 46.4 - 50% (w/v)
- Amount of vehicle: 10 mL/kg bw
- Justification for choice of vehicle: no data

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
Doses:
up to 10000 mg/kg bw; no further details
No. of animals per sex per dose:
5-10/sex/group; no further data
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of weighing: before the start of the study
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology
Statistics:
no data

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred.
Clinical signs:
In the highest dose group (10000 mg/kg bw), impaired general state with unspecific symptoms was noted at the first day of the study. No other findings were observed.
Body weight:
no data
Gross pathology:
No pathological findings were observed.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item revealed an acute oral LD50 greater than 10000 mg/kg bw in rats.
Executive summary:

The LD50 was > 10000 mg/kg bw.

Groups of male and female rats were administered the test substance by gavage as an aqueous solution at doses of up to 10000 mg/kg bw and were observed for 14 days. No deaths were observed. Clinical signs of toxicity were limited to impaired general state with unspecific symptoms observed at the highest dose level at the day after dosing only. Pathology revealed no abnormal findings.