Registration Dossier

Administrative data

Description of key information

Acute oral toxicity

Under the conditions of the study, the LD50 of the test material in male and female CrI:CDBR rats was estimated to be greater than 2000 mg/kg bodyweight.

Acute dermal toxicity

Under the conditions of the study, the LD50 has been determined to be greater than 2000 mg/kg bw in CrI:CDBR rats.

Acute Inhalation Toxicity

In accordance with Section 8.5.2. of Column 2 of Annex VIII of the REACH Regulation, the registrant proposes to waive the acute toxicity testing by the inhalation route on the basis that exposure to humans via inhalation is unlikely, taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
2 000 mg/kg bw
Quality of whole database:
The study was performed in accordance with standardised guidelines and under GLP conditions. The study was assigned a reliability score of 1 in line with the principles for assessing data quality as defined by Klimisch et al. (1997). The quality of the database is therefore considered to be good.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
2 000 mg/kg bw
Quality of whole database:
The study was performed in accordance with standardised guidelines and under GLP conditions. The study was assigned a reliability score of 1 in line with the principles for assessing data quality as defined by Klimisch et al. (1997). The quality of the database is therefore considered to be good.

Additional information

Acute Oral Toxicity

The acute oral toxicity of the test material was assessed in CrI:CDBR rats in accordance with the standardised guideline OECD 401 under GLP conditions.

The test material was evaluated when administered as a single dose via oral intubation at a dose level of 2000 mg/kg to 5 male and 5 female rats. Clinical observations were made 1, 2, 4, and 6 hours after dose administration and once daily for 14 days. Body weights were recorded for all animals the day prior to dosing, the day of dosing (Day 0), Day 7, and Day 14. On Day 14, surviving animals were sacrificed and gross necropsies were performed. All animals survived to scheduled termination on Day 14, were free of abnormalities throughout the study, and displayed increases in body weight over their initial values. At postmortem examination, all animals were free of gross abnormalities. Oral intubation of the test material at a dose level of 2000 mg/kg did not produce any test material-related mortality or overt signs of toxicity under conditions of this study. Under the conditions of the study, the LD50 of the test material in male and female CrI:CDBR rats was estimated to be greater than 2000 mg/kg bodyweight and as such requires no classification in accordance with EU criteria.

Acute Dermal Toxicity

A study was conducted to investigate the acute dermal toxicity of the test material in accordance with the standardised guideline OECD 402 under GLP conditions.

The acute dermal toxicity of the test material was evaluated following its application to the clipped backs often Crl:CDBR rats. A limit dose of 2000 mg/kg of the test material was applied to not less than 10 % of the body surface, covered with a gauze patch, and secured with non-irritating tape. The gauze patch was secured to the trunk of the animal with an occlusive covering held in place by Elastoplast to retard evaporation, to prevent ingestion of the test material, and to keep the substance in contact with the skin. After approximately 24 hours of exposure, the plastic sleeve and gauze patch were removed. Clinical observations were performed 1, 2, 4, and 6 hours after dosing, and once per day thereafter for a total of 14 days. Dermal responses were evaluated on Days 1 (approximately 45 minutes after patch removal), 3, 7, 10, and 14 according to the Draize method (Draize, 1959). Body weights were recorded on the day prior to dosing, on the day of dosing (Day 0), and on Days 7 and 14.

All animals survived to scheduled study termination on Day 14, were free of clinical signs or postmortem abnormalities, and gained weight over their initial (Day 0) values. Dermal irritation, initially observed in three animals on Day 1, was most pronounced on Day 3 when slight erythema was observed in three males and three females, and well-defined erythema was observed in two females. Slight oedema was only observed on Day 3 in three females. All animals were free of erythema and oedema on Day 7. Desquamation, observed in nine often animals on Day 3, persisted in three animals on Day 10. Dermal application of the test material at a limit dose of 2000 mg/kg did not produce any treatment related mortality or overt signs of toxicity under the conditions of this study. Transient dermal irritation was the only finding observed. Under the conditions of the study, the LD50 has been determined to be greater than 2000 mg/kg bw in the rat.

Acute Inhalation Toxicity

In accordance with Section 8.5.2. of Column 2 of Annex VIII of the REACH Regulation, the registrant proposes to waive the acute toxicity testing by the inhalation route on the basis that exposure to humans via inhalation is unlikely, taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size.

Justification for classification or non-classification

In accordance with the criteria for classification as defined in Annex I, Regulation 1272/2008, the test material does not require classification for acute oral and acute dermal toxicity.