Registration Dossier

Administrative data

Description of key information

ORAL: LD50 =  > 5000 mg/kg male/female rat; OECD 401, EU Method B.1; Guillot & Lheritier, 1986a
DERMAL: LD50 = > 2000 mg/kg male/female rat; OECD 402, EU Method B.3; Guillot & Lheritier, 1986b
INHALATION: no study available.

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 study was performed under GLP conditions and followed standardised guidelines OECD 401 and EU Method B.1. The study was therefore assigned a reliability score of 1 according to the criteria of Klimisch (1997) and considered suitable as an accurate reflection of the test material.

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 study was performed under GLP conditions and followed standardised guidelines OECD 402 and EU Method B.3. The study was therefore assigned a reliability score of 1 according to the criteria of Klimisch (1997) and considered suitable as an accurate reflection of the test material.

Additional information

ORAL

The acute oral toxicity of the test material was determined in accordance with standardised guidelines OECD 401 and EU Method B.1. In a preliminary study, groups of two male and two female rats were orally dosed 1000, 2500 and 5000 mg/kg test material, respectively. Animals were observed for a period of 14 days following treatment for mortality. Since none of the animals died, the definitive study was conducted with a single group of 5 males and 5 females treated with 5000 mg/kg test material and another group of 5 males and 5 females treated with water alone. During the study none of the animals died, no clinical signs were reported and the bodyweights of the treated animals were comparable to those of the controls. No detectable microscopic anomaly was detected, in any of the animals, at necropsy. Therefore, under the conditions of the study, the acute oral LD50 of the test material was determined to be in excess of 5000 mg/kg.

DERMAL

The acute dermal toxicity of the test material was determined in accordance with standardised guidelines OECD 402 and EU Method B.3. In a preliminary study, groups of two male and two female rats were subject to a semi occlusive dermal application of 1000 or 2000 mg/kg test material. Animals were observed for a period of 14 days following treatment. Since none of the animals died, the definitive study was conducted with a single group of 5 males and 5 females treated with 2000 mg/kg test material and a further group of 5 males and 5 females treated with water alone. During the definitive study none of the animals died, no clinical signs were reported and the bodyweights of the treated animals were comparable to those of the controls. No detectable microscopic anomaly was detected, in any of the animals, at necropsy. Furthermore, no local effects recorded with no skin lesion (erythema or edema) noted at the level of the site of application of the test material during the observation period. Therefore, under the conditions of the study, the acute dermal LD50 of the test material was determined to be in excess of 2000 mg/kg bw.

INHALATION

The test substance has very low vapour pressure and high melting point, so the potential for the generation of inhalable forms is low; also the use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be unlikely to occur, and no acute inhalation test was performed.


Justification for selection of acute toxicity – oral endpoint
Only one study available.

Justification for selection of acute toxicity – dermal endpoint
Only one study available.

Justification for classification or non-classification

ORAL

In accordance with with criteria for classification as defined in Annex I, Regulation 1272/2008, the test material does not require classification for acute oral toxicity as no signs of toxicity were noted during the course of the study.

DERMAL

In accordance with with criteria for classification as defined in Annex I, Regulation 1272/2008, the test material does not require classification for acute dermal toxicity as no signs of toxicity were noted during the course of the study.