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Administrative data

Description of key information

Two acute oral toxicity studies have been performed, one key study and one supporting study performed on three species. None were following a guideline nor performed under GLP. All results yielded high LD50 values > 3000 mg/kg bw.

One acute dermal toxicity study is available, in which no mortality was observed upon administration of a dermal dose (5000 mg/kg bw) of the test item.

The acute oral and dermal studies are taken together in a weight of evidence approach. The available data show that the substance does not exert acute toxicity, irrespective of the administration route.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
3 300 mg/kg bw
Quality of whole database:
The key study on rats has no details on the study design.It was performed similar to OECD TG 401 and pre-GLP.
For the supporting study performed on guinea pigs, rats and mice no guideline has been followed and the study is pre-GLP. There is not much of information available.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw
Quality of whole database:
The key study on rabbits has no details on the study design and did not follow a guideline. It was performed pre-GLP.

Additional information

Acute toxicity: oral

There are 2 studies available assessing the acute toxicity of the test item via the oral route.

None of these studies is performed according to internationally accepted guidelines or GLP, and the documentation of the test method and results is in general limited. One study (1974) is therefore assigned a Klimisch 4 score. The key study (1972) was assigned a Klimisch score 2. Nevertheless, as the outcome of all studies consistently shows a very low acute toxicity, in addition to the key study the supporting study on several species is used to fulfil the information requirements for this endpoint, and to determine the classification of the test substance. Additional testing is deemed to not bring new information to the acute toxicity assessment, and hence is omitted in order to avoid unnecessary vertebrate animal testing.

The 1974 study addresses the oral acute toxicity to rats, mice and guinea pigs by dosing the test substance dissolved in sunflower-seed oil via oral gavage. 6 Male and 6 female animals were dosed per experiment. The animals were observed for 15 days following the single exposure. Each of these 3 experiments resulted in an LD50 value of 4750 mg/kg bw.

In the second oral toxicity study (key, 1972) the toxicity of the test substance was assessed when administered to rats in four oral doses. The test substance was administered orally to 10 rats per dose, at 1460, 2220, 3330 and 5000 mg/kg body weight. 17 animals died during the study. Slow respiration, lethargy, depression, coarse tremors in high doses, death overnight to 2 days were observed during the 14 days observational period.

The oral LD50 value of the test substance in rats was established as 3300 mg/kg body weight.

The above experiments allow to conclude that the substance exerts only low acute oral toxicity.

Classification according to the CLP Regulation No 1272/2008 is not necessary as the LD50 is higher than 2000 mg/kg bw.

Acute toxicity: dermal

The purpose of the acute dermal study was to assess the toxicity of the test substance when administered to rabbits in one dermal dose. The test substance was administered dermally to 10 rabbits at a dose of 5000 mg/kg body weight. No animal died during the study and no clinical signs could be observed during the 14 days observational period.

The dermal LD50 value of the test substance in rabbits was established as to be greater than 5000 mg/kg body weight.

The acute oral and dermal studies are taken together in a weight of evidence approach. The available data show that the substance does not exert acute toxicity, irrespective of the administration route. As a consequence, classification according to the CLP Regulation No 1272/2008 is not necessary. These results further prove the low acute toxicity of the test substance.

Justification for classification or non-classification

Acute oral toxicity

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

Acute dermal toxicity

According to the CLP legislation a substance is considered acute toxic when the acute toxicity estimates (ATE) for the dermal route are =< 2000 mg/kg bodyweight. As the LD50 of the test item > 2000 mg/kg bw, the substance has not to be classified as acute toxic for the dermal route.