Registration Dossier

Administrative data

Description of key information

Acute oral toxicity : The oral LD50 in male and female Sprague-Dawley rats was determined to be 5000 mg/kg bw in a reliable, key study conducted similarly to OECD guideline 420 (Calvert Laboratories, Inc., 2010).
Acute inhalation toxicity: No reliable data were available. However, this endpoint is waived for the inhalation route as specific data are available for the oral and dermal route.
Acute dermal toxicity: In a reliable, key study conducted similarly to OECD guideline 402 and EPA OPPTS 870.1200, the acute dermal LD50 was determined to be greater than 2000 mg/kg bw in male and female Sprague-Dawley rats.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw

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

Additional information

Acute toxicity: oral

Calvert Laboratories, Inc. (2010) investigated acute oral toxicity (by gavage) of the test substance in male/female Sprague-Dawley rats. The study was performed equivalent to OECD Guideline 420 (fixed dose method, key study, K1). Following doses were applied: 1000, 2000, 5000 mg/kg bw. The LD50 was concluded to be 5000 mg/kg. For the dose levels of 1000 and 2000 mg/kg bw, no mortality was observed. In the 5000 mg/kg bw dose group, one male four female animals died. No clinical signs were observed in the groups dosed 1000 or 2000 mg/kg bw. In the highest dose group, the following clinical signs were observed: decreased body tone (10/10 animals), brown discoloured fur around eyes (2/10), piloerection (2/10), abnormal gait and stance (3/10), dischard (clear) eye (1/10), decreased activity (1/10). Three animals were found dead on the second day after exposure. One animals was found death on day 3. No effects on body weight were observed. No visible lesions were seen at 1000 and 2000 mg/kg bw. In the animals that were found dead on day 2 and day 3 after exposure, following lesions were found: distended stomach, red to black fluid filled, dark lesions in stomach.

Acute toxicity: inhalation

According to the REACH Regulation, in addition to the oral route, for substances other than gases, the information mentioned under sections 8.5.2 to 8.5.3 shall be provided for at least one other route. The choice for the second route will depend on the nature of the substance and the likely route of human exposure. Based on the properties of the substance, the inhalation route of exposure is not considered to be relevant (column 2 adaptation, Annex VIII, section 8.5).

Acute toxicity: dermal

Calvert Laboratories Inc (2010) determined acute dermal toxicity in 10 male / female rats following a GLP-compliant study performed equivalent to OECD guideline 402 (key study, Klimisch 1). Only one dose was tested (2000 mg/kg bw). No mortality was observed. Shortly after exposure, local erythema and edema effects were observed in both males and females. The effects seemed to be reversible in males and 1 female. In the 4 other females, necorsis and slouching appeared.

Justification for classification or non-classification

Based on the available data and according to the criteria laid down in the CLP Regulation (EC) 1272/2008, the test substance should not be classified as acute toxic via the oral and dermal route.

No reliable acute inhalation studies are available for the test substance. Therefore, no conclusion can be made on the classification for acute inhalation toxicity for this substance.