Registration Dossier

Administrative data

Description of key information

LD50 > 2000 mg/kg in acute toxicity studies involving administration of test material to the Wistar rat via the oral route (OECD 420 and EU Method B.1 bis) and the dermal route (OECD 402 and EU Method B.3).

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

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

Additional information

Oral

 

The test material was investigated in a key study designed to be compatible with OECD Guideline for Testing of Chemicals No 420 "Acute Oral Toxicity - Fixed Dose Method" (2001) and Method B.1 bis Acute Toxicity (Oral) of Commission Regulation (EC) No 440/2008.

 

Following a sighting test at a dose level of 2000 mg/kg, an additional four fasted female animals were given a single oral dose of the test item, as a solution in arachis oil BP, at a dose level of 2000 mg/kg body weight. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy.

 

There were no deaths, no signs of systemic toxicity, all animals showed expected gains in body weight and no abnormalities were noted at necropsy.

 

The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was considered to be greater than 2000 mg/kg body weight.

 

Inhalation

 

According to REACH Annex VIII, Section 8.5, Column 2, information on acute toxicity shall be provided for at least one other route in addition to the oral route. The choice for the second route will depend on the nature of the substance and the likely route of human exposure. The substance is a viscous liquid with a vapour pressure of 0.027 Pa at 25°C and, based on evaluation of the life cycle of the substance, it is expected that exposure inhalation exposure will be low. The most likely route of exposure for workers and consumers is considered to be the dermal route and testing for acute toxicity via the inhalation route is not required.

 

Dermal

 

The test item was investigated using a method designed to be compatible with OECD Guidelines for the Testing of Chemicals No 402 "Acute Dermal Toxicity" (adopted 24 February 1987) and Method B3 Acute Toxicity (Dermal) of Commission Regulation (EC) No 440/2008.

 

Initially, two animals (one male and one female) were given a single, 24 hour, semi-occluded dermal application of the test item to intact skin at a dose level of 2000 mg/kg bw. Based on the results of the initial test, a further group of eight animals (four males and four females) were treated similarly. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy.

 

No animal deaths took place during the study, no signs of systemic toxicity were observed, no signs of dermal irritation were reported, all animals showed expected gains in body weight and no abnormalities were noted at necropsy.

 

The acute dermal median lethal dose (LD50) of the test item in the Wistar strain rat was found to be greater than 2000 mg/kg body weight.


Justification for selection of acute toxicity – oral endpoint
GLP guideline study

Justification for selection of acute toxicity – dermal endpoint
GLP guideline study

Justification for classification or non-classification

No adverse effect was observed during investigation of acute toxicity via the oral or dermal routes in the Wistar rat. As such, classification in accordance with Regulation (EC) No 1272/2008 is not required.