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Administrative data

Description of key information

Oral:
Three acute oral toxicity were conducted, all demonstrating the low acute oral toxicity of this material. In the key study, 3 groups of fasted Sprague-Dawley strain albino rats (6 male per dose) were given a single oral dose of undiluted test material at a dose level of 5,000, 7,500 and 10,000  mg/kg bw and observed for 14 days. 3/6 animals in the highest dose group were found dead one day after the treatment, no mortality occurred in the other two groups. The oral LD50 value of test material in rats was determined to be 10,000 mg/kg bw. The NOAEL is 7500 mg/kg, the dose in this study that did not result in any lethality.
Dermal:
Eight groups of four albino rabbits of either sex, weighing between 1.4 and 2.3 kilograms (kg) were used to evaluate the dermal toxicity of the test material. Four dosage levels were administered; each level was administered to a group of four animals whose closely clipped abdominal skin was left intact and to a corresponding abraded group. The dosage levels tested were 10.3, 15.4, 20.5, and 25.6 g/kg of body weight. The sites were occluded for 24 hours and then the dressings were removed and the sites washed with Wesson oil.
For the intact skin doses there were no deaths, signs of toxicity, weight loss or gross abnormalities at any dose level tested.
The acute dermal LD50 of the test material when applied to the intact skin of rabbits is greater than 25.6 g/kg of body weight.
The test material is dermally non-toxic within the meaning of the Federal Hazardous Substances Labeling Act.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
10 000 mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
discriminating dose
25 600 mg/kg bw

Additional information

Oral

Three studies for acute oral toxicity all resulted in low toxicity. The key study for oral exposure (Swan, CB 1973 report number 2121087) was selected because it had the lowest LD50 value of 10,000 mg/kg/bw. This study was assigned a reliability rating of 2 according to the criteria of Klimisch, 1997.

The supporting studies summaries are as follows:

- The Cavalli et al study, 1968 was considered to have a reliability rating of 2, according to the criteria of Klimisch, 1997.

5 rats were given 15 g/kg of the test material and observed for a 14 day period. None of five rats dosed at 15 g/kg died, there were no signs of toxicity and there were no gross abnormalities found at autopsy 14 days after dosing. The acute lethal oral dose is greater than 15 g/kg.

- The Meyding & Fogleman study, 1962 was considered to have a reliability rating of 2, according to the criteria of Klimisch, 1997.

Groups of seven male albino rats of the Sprague-Dawley Strain weighing between 150 and 237 grams received orally by stomach tube single oral doses of the undiluted test material . The dosage levels tested were 1.03, 8.20, 10.3, 15.4, and 20.5 grams per kilogram (g/kg) of body weight. The acute oral LD50 of the test material for male rats is greater than 20.5 g/kg of body weight.

Dermal

In the key study for dermal exposure (Meyding & Fogleman, 1962, Report number: 20-0169-33) there was no mention of the guideline, however the methodology suggests that it was conducted similarly to OECD 402. The study pre-dates GLP. A reliability rating of 2 according to the criteria of Klimisch, 1997. This was considered to be the most robust study available and used more animals per dose than the available supporting study.

The following supporting study is also available for this endpoint:

- The Cavalliet alstudy, 1968 was not considered the key study as it was not considered as robust as the above key study, was not conducted according to a recognised guidelines or GLP and there was limited information on results. The study was considered to have a reliability rating of 4, according to the criteria of Klimisch, 1997, due to only 2 animlas being tested at one very high dose level which would be considered severe deviations according to recent recognised guidelines. The sites were also occluded and only males were used. 2 rabbits were administered 15 g/kg of the test material to the skin and observed for a 14 day period. None of two rabbits dosed at 15 g/kg died, there were no signs of toxicity and there were no gross abnormalities found at autopsy 14 days after dosing. The acute lethal oral dose is greater than 15 g/kg.

Inhalation

In accordance with column 2 of REACH Annex VIII, section 8.5.2, it is considered justifiable to omit the acute toxicity: inhalation study taking into account the low vapour pressure of the substance (<0.013 Pa) hence it is unlikely to be aerosolized in its normal use pattern and does not exist as small particles or droplets. As such testing via the inhalation route is not considered appropriate for this substance.

Justification for classification or non-classification

Oral

The key parameter chosen for acute toxicity for the oral route was greater than the criteria set out in Directive 67/548/EEC and also Regulation (EC) no 1272/2008, therefore classification for acute toxicity was not considered to be necessary.

Dermal

The key parameter chosen for acute toxicity for the dermal route was greater than the criteria set out in Directive 67/548/EEC and also Regulation (EC) no 1272/2008, therefore classification for acute toxicity was not considered to be necessary.