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Administrative data

Description of key information

The substance is not acute toxic. The oral LD50 is > 4315 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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
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
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
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.
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.
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
4 315 mg/kg bw
Quality of whole database:
The study was similar to internationally accepted guidelines and well documented. An LD50 was determined.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

For the acute toxicity endpoint there is one study available.

In the key study (1980) the oral acute toxicity was assessed in 5 male and 5 female mice. The study was similar to OECD TG 423, with a deviation for the observation period after dosing and the amount of animals used per dose. 2 animals were dosed 8630 or 1726 mg/kg bw and 6 animals were dosed 4315 mg/kg bw. The observation period was 7 days. No animals died during the test and no clinical signs were observed at any dose level. Weight gain was normal as well as the autopsy. For the middle dose sufficient animals were used and therefore the LD50 is > 4315 mg/kg bw.

Concluding, the test item is not acute toxic for the oral route.

Justification for classification or non-classification

According to the CLP legislation a substance is considered acute toxic when the acute toxicity estimates (ATE) for the oral route is =< 2000 mg/kg bodyweight. The oral LD50 of the test item is 4315 mg/kg bw and thus the substance is not to be classified as acute toxic for the oral route.

The available data is sufficient to not classify the substance as an acute toxic substance.