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Administrative data

Description of key information

Oral:
Under the experimental conditions described in the study, the oral LD 50 of the test item was found to be greater than 2000 mg/kg bw in the rat.
Dermal:
Under the experimental conditions described in the study report, the dermal LD50 of the test item was found to be greater than 2000 mg/kg bw in rats.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

Oral:

The acute oral toxicity in rats was determined according to the method recommended in the OECD Guideline No. 423, "Acute Oral Toxicity - Acute Toxic Class Method", December 2001.

The study was carried out with two groups consisting of three female animals each given a dose of 2000 mg/kg bw. Neither animals of the first group nor of the second group died on account of the treatment nor did they show severe signs of toxicosis. The clinical signs of the rats observed daily throughout the study were as follows:

First group; female: Animals No.1, No.2 and No. 3 showed piloerection 30 min and 2 hours after the application of the test item. After 4 hours and 6 hoursas well as from day 1 to the end of the observation period on day 14 no abnormalities were observed. Second group; female: Animals No.4, No.5 and No. 6 showed piloerection 30 min and 2 hours after the application of the test item. After 4 hours and 6 hours as well as from day 1 to the end of the observation period on day 14 no abnormalities were observed.

The rats had a normal body weight gain during the study period. The gross necropsy revealed no pathological abnormalities.

Under the experimental conditions of the study, the oral LD50 of the test item in rats was found to be greater than 2000 mg/kg bw.

Dermal:

The acute dermal toxicity of the test item was determined according to the method recommended in the OECD Guideline No. 402 "Acute Dermal Toxicity", Feb. 1987, and the corresponding EEC Guideline B.3 "Acute Toxicity(Dermal)", Jan 1997.The study was performed as a limit test with 10 Wistar rats (5 males and 5 females). The rats were exposed to a single dermal dose of 2000 mg/kg bw for 24 hours, followed by an observation period of 14 days. During the study clinical signs of reaction to the treatment were recorded daily. Body weight was recorded once a week. After the two week observation period the animals were killed and subjected to a gross necropsy. The following clinical signs were observed:

Males: Animals No. 2, No. 3, No.4, No.5 and No. 6 appeared apathetically on day 0 after 1 hour, 3 hours and 6 hours. from day 1 to the end of the observation period on day 14 no abnormalities were revealed.

Females: Animals No. 7, No. 8, No. 9, No. 10 and No. 11 appeared apathetically on day 0 after 1 hour, 3 hours and 6 hours. from day 1 to the end of the observation period on day 14 no abnormalities were revealed.

The rats had a normal body weight gain during the study period. The post mortem inspection of the female animals revealed no pathological abnormalities. Two of the male rats (animal No. 2 and No. 5) had marbled kidneys, whereas the remaining animals were inconspiciously.

Conclusion: Under the experimental conditions of this study, the dermal LD50 of the test itemin rats was found to be greater than 2000 mg/kg bw.

Justification for classification or non-classification

No classification and labelling is required according to Regulation No (EC) 1272/2008 (CLP) or Directive 67/548/EEC (DSD) criteria.