Registration Dossier

Administrative data

Description of key information

Oral (OECD 423), rat (m/f): LD50 (cut-off) > 5000 mg/kg bw (limit test)
Dermal (OECD 402), rat (m/f): LD50 > 2000 mg/kg bw (limit test)

Key value for chemical safety assessment

Acute toxicity: via oral 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 VII, 8.5, of Regulation (EC) No 1907/2006.

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 VII, 8.5, of Regulation (EC) No 1907/2006.

Additional information

Acute toxicity

Oral

The acute toxicity of the test substance was determined in a GLP-conform study according to the acute toxic class method (OECD 423), in which two groups of 3 female Wistar rats were exposed to the limit dose of 2000 mg/kg bw of the test substance in sterile water by single gavage application (Holalagoudar, 2012). No mortalities occurred during the study period and clinical signs of toxicity including reduced spontaneous activity, piloerection and half eye-lid closure were only observed in 1 of 6 animals 1 to 4 h after administration of the test substance . Body weight gain was within the normal range of variation for animals of this strain throughout the 14-day study period. Necropsy did not reveal any gross pathological findings in the animals of any step. Based on these experimental results, the LD50 was greater than 2000 mg/kg bw. According to the criteria of OECD guideline 423, the LD50 cut-off is considered to be greater than 5000 mg/kg bw.

Dermal

The acute dermal toxicity of the test substance was investigated in accordance with OECD 402 and in compliance with GLP (Holalagoudar, 2012). The study was performed as a limit test in Wistar rats (5 males and 5 females) at a dose of 2000 mg/kg bw. The test substance was moistened with sterile water and applied to the clipped skin of the test animals for approx. 24 h under semiocclusive conditions. After removal of the test substance, animals were observed for mortality, clinical signs of toxicity and changes in body weight during a 14-day observation period. In addition, the formation of erythema and edema was assessed using the Draize scoring system from Day 2 after application of the test substance up to the end of the study. No treatment-related mortalities occurred, but clinical signs of toxicity including nasal discharge, slightly reduced spontaneous activity and slight piloerection were observed in 2 of 5 males and 3 of 5 females at the beginning of the 14-day observation period. The body weight evolution in all animals was not affected by treatment, except for a slight loss in body weight during the first week of the study in all females. However, this effect was not clearly attributable to treatment, since females showed weight gain during the second week of the study. No specific gross pathological changes were found at macroscopic post-mortem examination of the animals, except for acute injection of blood vessels in the abdominal region due to euthanasia injection. No erythema and edema were observed during the study period. During Days 6 to 8 of the observation period, eschar formation was noted in 1 of 5 males and 1 of 5 females, but was fully reversible until the end of the study. Based on these results, the dermal LD50 value for male and female rats was greater than 2000 mg/kg bw.

Inhalation

This information is not available.


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

Justification for selection of acute toxicity – inhalation endpoint
Study not required according to Annex VIII 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

Based on the available data on acute toxicity, the test substance does not meet the criteria for classification according to Regulation (EC) No 1272/2008 or Directive 67/548/EEC.