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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

LD50, rat, oral: > 5653 mg/kg bw (BASF AG, 1970).

Key value for chemical safety assessment

Additional information

Oral:

In the key study that was performed equivalent or similar to OECD TG 401 several groups of 10 rats per sex and dose were treated simultaneously by gavage with preparations of the test substance in traganth (BASF AG, 1970). The concentrations of these preparations were used to achieve comparable volumes per kg body weight. Group-wise documentation of clinical signs was performed over the 7 day study period. Body weight was determined before the start of the study only, as it was needed for determination of dose. No mortalities in occured in the 0.2, 1.6 and 3.2 ml/kg bw dose groups, one female in the 6.4 ml/kg bw dose group died. Under the conditions of this study the LD50 for male and female rats after oral application was determined to be > 6.4 ml/kg bw = 5653 mg/kg bw.

Supportingly, in an acute oral toxicity study that was performed according to the OECD guideline "Acute oral toxicity" (adopted May 12, 1981) in groups of 5 rats per sex and dose the acute oral LD50 in rats of both sexes observed over a period of 14 days was estimated to be greater than 20000 mg/kg bw (Evonik, 1982).

In another study the single oral dose toxicity was estimated by the gastric intubation of groups of five non-fasted Sherman male rats (Smyth et al. 1951). Based upon mortalities during a 14-day observation period, the most probable LD50 value and its fiducial range were estimated by the method of Thompson using the Tables of Weil. In this study, the LD50 was determined to be 7340 mg/kg bw in male rats.

Dermal:

No reliable data available.

Inhalation:

In an inhalation hazard test that demonstrates the toxicity of an atmosphere saturated with vapors of the volatile components of a test substance at 20°C young adult laboratory rats, 6 per sex, were exposed sequentially to the vapors generated by bubbling 200 L/h air through a substance column of about 5 cm above a fritted glass disc in a glass cylinder for 8 h (BASF AG, 1970). The exposure was subsequently repeated in the same manner. No analytical determination of the atmosphere concentrations was performed. The nominal concentration was calculated to be 11.1 mg/L air. Group-wise documentation of clinical signs was performed over a 7-day study period. Body weight of groups was determined before the start of the study and at the end of the observation period. No mortality occured. Strong irritation of mucous membranes of the test animals was observed. Nothing abnormal was detected at necropsy.

Other routes:

The substance was injected into the peritoneal cavity of young adult mice (BASF AG, 1970). Several groups of 5 mice per sex and dose were treated simultaneously with preparations of the test substance in traganth. The concentrations of these preparations were used to achieve comparable volumes per kg body weight. Group-wise documentation of clinical signs was performed over the 7 day study period. Body weight was determined before the start of the study only, as it was needed for determination of dose. Under the conditions of this study the LD50 for male an female mice after i.p. application was determined to be approximately 1.8 ml/kg bw = 1590 mg/kg bw.

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC):

The available experimental test data concerning acute oral and inhalation toxicity are reliable and suitable for the purpose of classification under Directive 67/548/EEC. These data are conclusive but not sufficient for classification concerning acute oral or inhalation toxicity.

No classification is warranted concerning acute dermal toxicity due to lacking data.

 

Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008:

The available experimental test data concerning acute oral and inhalation toxicity are reliable and suitable for the purpose of classification under Regulation (EC) No. 1272/2008. As a result no classification is warranted concerning acute oral or acute inhalation toxicity (data conclusive but not sufficient for classification).

No classification is warranted concerning acute dermal toxicity due to lacking data.