Registration Dossier

Administrative data

Description of key information

Oral (OECD 423), rat: LD50 cut-off value: unclassified
Dermal (OECD 402), rat: LD50: > 2000 mg/kg bw (limit test)

Key value for chemical safety assessment

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
Quality of whole database:
The available information comprises an adequate and reliable study (Klimisch score 1), and is thus sufficient to fulfil the standard information requirements set out in Annex VIII, 8.5, of Regulation (EC) No 1907/2006.

Additional information

Acute toxicity

Acute toxicity: oral

The acute toxicity of the test substance was determined in a recent GLP-Guideline study according to the acute toxic class method (OECD 423) in which two groups of 3 female Wistar rats were exposed to 2000 mg/kg bw in a single oral application of 10 mL/kg bw via gavage (Lütkenhaus, 2011a). According to OECD 423, morbidity and mortality, clinical signs, alterations in body weight and cageside observations were performed in addition to examination of the respiratory, circulatory, autonomic and central nervous system. At the end of the study, all animals were necropsied and examined macroscopically. The test substance did not show any sign of acute toxicity after a single application of 2000 mg/kg bw. In detail, no alterations in clinical signs or on body weight gain were determined until the end of the study period. Further, pathological examinations did not reveal any specific gross pathological findings with the exception of acute injection of blood vessels in the abdominal region which is due to the euthanasia injection. Thus, a LD50 > 2000 mg/kg bw was derived. Taken these data into consideration, the test substance is not classified according to GHS.

 

Acute toxicity: dermal

Acute dermal toxicity was evaluated in a GLP-guideline study according to OECD guideline 402 (Lütkenhaus, 2012). In detail, 2000 mg test substance/kg bw with a purity of 74.9% (main constituent: 54.3%) were topically applied to the clipped dorsal area of the trunk of 5 Wistar Crl:WI (Han) rats per sex for 24 hours. Animals were observed for clinical signs, mortality and skin reactions over a time period of 14 days. At the end of the observation period, no signs of acute toxicity were observed. Body weight development of the test animals was within the expected range. In contrast to males, all 5 females showed slight dermal irritation on day 6 lasting for up to 48 hours visible as erythema with a score of 1. 2 females revealed scratches on the skin resulting in eschar formation in one female. Moreover, one female test animal showed a slight nasal discharge on day 2 which was explained by the administration procedure and the related stress induction. Pathological examinations revealed dark spots in one female which are not considered as treatment-related but incidental as the other test animals did not show similar effects with the exception of acute injection of blood vessels in the abdominal region due to euthanasia injection. Thus, a LD50 > 2000 mg/kg bw was derived. Therefore, the test substance is not considered to induce acute toxic effects after dermal application.

Inhalation

This information is not available.

 

In conclusion, the test substance does not meet the criteria for classification according to GHS in regard to acute toxicity after oral or dermal exposure.


Justification for selection of acute toxicity – inhalation endpoint
Study not required according to Annex VIII, 8.5, of Regulation (EC) No. 1907/2006.

Justification for selection of acute toxicity – dermal endpoint
There is only one study available.

Justification for classification or non-classification

The available data on oral and dermal acute toxicity of the test substance do not meet the criteria for classification according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.