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Administrative data

Description of key information

oral
rat: LD50 >2000 mg/kg bw (comparable to OECD 401; BASF AG 1975)
dermal
rat: LD50 >2000 mg/kg bw; Signs of toxicity were not noted (GLP, OECD 402; BASF SE 2010)
inhalation
rat: IHT, 8h: 0/12 animals died after exposure to a saturated atmosphere; signs of systemic toxicity were not noted (comparable to OECD 403; BASF AG 1975)

Key value for chemical safety assessment

Additional information

There are reliable data available to assess the acute toxicity of the test substance.

 

oral

The study comparable to OECD 401 with acceptable restrictions mostly due to reduced reporting in times before GLP was performed to assess the oral acute toxicity of Golpanol ALS (purity: 25 weight-% in water; dose volume: 10 ml/kg bw) in

Sprague-Dawley rats (BASF AG, 1975). Two female rates were each administered 100 and 1000 µl/kg and groups of 5 rats per sex and dose were administered 10000 µl/kg of the test substance per gavage. No mortality occurred in the 100 and 1000 µl/kg administration groups. One female of the 10000 µl/kg administration group died one day after administration. Sporadic dyspnoea, apathy and diarrhoea were observed at day 0 of the 10000 µl/kg administration group as reversible clinical signs. Sporadic pneumotic areals in lungs were found in the animals of the 10000 µl/kg administration group by necropsy at the end of the observation period. The mean body weights of the animals were in the normal range throughout the study period.

Under the conditions of this study the median lethal dose of Golpanol ALS after oral application was found to be greater than 10000 µl/kg body weight for the test substance corresponding to > 2000 mg/kg body weight for the male and female animals.

 

dermal

A GLP conform study was performed to assess the acute toxicity following dermal administration of Golpanol ALS wasserfrei in young adult Wistar rats according to OECD guideline 402 (BASF SE, 2010).

One group of ten animals (five males and five females) were dermaly exposed to a single dose of the test material preparation (purity: Golpanol ALS 71.3 weight-%; dose volume: 5 ml/kg bw) in doubly distilled water at a dose level of 2000 mg/kg body weight. The application area comprised at least 10% of body surface area. The animals were observed for 14 days.

No mortality was noted. No signs of systemic toxicity or skin effects were observed in the animals. The mean body weight of the animals increased within the normal range throughout the study period. No macroscopic pathologic abnormalities were noted in the animals examined at the end of the study.

Under the conditions of this study the median lethal dose of Golpanol ALS after dermal application was found to be greater than 2000 mg/kg body weight for the test material in male and female animals.

 

inhalation

The study comparable to the inhalation hazard test (IHT) described in the Annex of OECD 403 (adopted 1981) with acceptable restrictions was performed to assess the inhalative acute toxicity of Golpanol ALS in Wistar rats (BASF AG, 1975). Two groups of 3 rats per sex and dose were exposed for 8 h to vapour saturated air (nominal 4.71 mg/L of the test substance, calculated by weight loss of an aerated substance column) in a sequential manner. No mortality occurred. Strong mucosa irritation and eyelid closure on the day of exposure were observed as reversible clinical signs. The first day after exposure no abnormalities were detected anymore. At the end of the observation period no effects were observed at gross pathology. The mean body weights of the animals were in the normal range throughout the study period.

Under the conditions of this inhalation hazard test, none of the animals died after an inhalative exposure of 8 hours to a saturated vapour atmosphere of Golpanol ALS.

 

Justification for classification or non-classification

oral

Based on the available data, the LD50 level is > 2000 mg/kg bw in rats. 1/10 animals died in the highest dose tested and reversible clinical signs were observed at this dose level. Therefore, no indication is warranted for a classification according to the criteria of DSD (67/548/EEC) and CLP (1272/2008/EC), respectively.

 

dermal

No signs of toxicity were observed at 2000 mg/kg bw in rats for the test material. Therefore, no indication is warranted for classification according to the criteria of DSD (67/548/EEC) and CLP (1272/2008/EC), respectively.

 

inhalation

No systemic signs of toxicity were observed after exposure to vapour saturated atmosphere. Therefore, there is no indication warranted for classification according to the criteria of DSD (67/548/EEC) and CLP (1272/2008/EC), respectively.