Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Principles of method if other than guideline:
The test is performed for suspected low toxic materials to determine an approximate order of toxicity. 3 male and 3 female animals are dosed with the most relevant dose levels for the class of substance. Two groups of 1 male and 1 female are dosed above and below this level.
The animals are observed for 7 days.
GLP compliance:
not specified
Test type:
other: Range finding study
Limit test:
no

Test material

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

Test animals

Species:
mouse
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 4-5 weeks old
- Fasting period before study: yes, 4h
- Diet: commercial pelleted diet
- Water: ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
8630, 4315 and 1726 mg/kg bw (corresponding to 10.0, 5.0 and 2.0 mL/kg bw).
No. of animals per sex per dose:
1 male and 1 female for highest and lowest dose, 3 males and 3 females for middle dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: at the beginning of the test and before killing
- Necropsy of survivors performed: yes
Statistics:
The LD50 value is estimated from the results and the test substance is given a toxicity rating according to Hodge and Sterner's classification.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 4 315 mg/kg bw
Based on:
test mat.
Mortality:
No animals died during the test.
Clinical signs:
No clinical signs were observed at any dose level. The animals presented a normal appearance at autopsy.
Body weight:
Weight gain was normal.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The substance is not acute toxic, the LD50 is > 4315 mg/kg bw.
Executive summary:

The test is performed for suspected low toxic materials to determine an approximate order of toxicity using 5 male and 5 female animals. The most relevant dose levels for the class of substance is selected, and 3 male and 3 female animals are dosed at this level. Two groups of 1 male and 1 female are dosed above and below this level.

The study was similar to OECD TG 423, however, with deviations such as the observation period after dosing of 7 days.

The animals were dosed 8630, 4315 or 1726 mg/kg bw and observed for 7 days. Body weight was assessed at the beginning of the test and before killing of the animals. All animals were necropsied.

No animals died during the test and no clinical signs were observed at any dose level. Weight gain was normal and the animals presented a normal appearance at autopsy.

In the study the LD50 was therefore > 8630 mg/kg, however, according to the OECD TG 423 the substance is tested using a stepwise procedure, each step using 3 animals of a single sex (normally females). For the middle dose the accurate amount of animals was used in this study and therefore the LD50 is > 4315 mg/kg bw. The substance should not be considered as acute oral toxic.