Registration Dossier

Administrative data

Description of key information

Under the conditions of the study, the LD50 and 95 % confidence limits were determined to be 2700 (2300 to 3500) mg/kg for

males and 2100 (1100 to 3400) mg/kg for females.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
2 100 mg/kg bw
Quality of whole database:
There are two studies available to address this endpoint, therefore, the quality of the database is good.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Acute Oral Toxicity

There are two studies available to address this endpoint, one key and one supporting.

The key study, Dougherty (1989), was conducted to determine the acute oral toxicity of the test material on male and female rats. The study has been conducted under GLP conditions and to similar or equivalent methodology of that found in the standardised guideline OECD 401. The study report is thorough, and although it does not state a guideline, this study has been assigned a reliability score of 1 in line with the principles for assessing data quality as defined by Klimisch et al. (1997).

Single doses of the undiluted test material ranging from 1.3 to 3.0 g/kg were administered via gavage to fasted male or female rats. Clinical signs of toxicity and body weight were recorded during the 14 day observation period. After this, any surviving animals were sacrificed via carbon dioxide inhalation and a necropsy was performed.

All deaths occurred by Day 3. Frequently observed signs of toxicity observed were salivation; anogenital, nasal and ocular discharge; decreased motor activity; soft faeces and reduced food consumption. No signs of toxicity were evident in surviving animals after Day 5.

Compound-related pathological changes included gastric necrosis of the glandular and non-glandular portions of the stomach. Other findings were probably secondary lesions associated with the loss of integrity in the gastric mucosa or secondary to vascular shock associated with an agonal death.

In conclusion, the test material had an LD50 of 2.7 g/kg for males and 2.1 g/kg for females. No compound-related signs of toxicity were evident after Day 5. Compound-related pathological changes were observed in the stomach.

 Under the conditions of the study, the LD50 and 95 % confidence limits were 2700 (2300 to 3500) mg/kg for males and 2100 (1100 to 3400) mg/kg for females. The slope and 95 % confidence limits were 19800 (2600 to 36900) for males and 11100 (1600 to 20600) for females. Under EU regulation, the test item is not classified.

 

The supporting study that has been performed on the substance, Gabriel (1976), was performed to investigate the acute oral toxicity of the test material. The study was performed using similar or equivalent methodology to that found in the standardised guideline OECD 401. The report itself is relatively short and does not state a guideline. However, it is clear to understand and to follow the study. The study has not been performed under GLP conditions. Therefore, the study has been assigned a reliability score of 2 in line with the principles for assessing data quality as defined by Klimisch et al. (1997).

Five groups of five male albino rats of the Sherman-Wistar Strain weighing between 200 and 300 g were employed in this study. The rats were deprived of food but not water for 24 hours prior to dosing. Each animal was weighed and dosed by direct administration of the experimental material into the stomach by means of a syringe and dosing needle. The sample was dosed as a 50 % w/v suspension in corn oil. The following dosage levels were administered: 1.25, 2.5, 5.0, 10.0 and 20.0 mL/kg

Following administration the animals were allowed food and water ad libitum for the 14 day observation period during which time the rats were observed for signs of toxicity and mortalities.

Under the conditions of the study, the test material was found to have an LD50 of 4100 mg/kg (95 % confidence limit of 3100 to 5400 mg/kg). Under EU regulation, this test material is not classified.

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.

Acute Dermal Toxicity

In accordance with Section 8.5.3. of Column 2 of Annex VIII of the REACH Regulation, the registrant proposes to waive the acute toxicity testing by the dermal route on the basis that the substance does not meet the criteria for classification as acutely toxic up to 2000 mg/kg bw or STOT SE by the oral route.

Justification for classification or non-classification

In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No 1272/2008, the substance does not require classification with respect to acute toxicity.