Registration Dossier

Administrative data

Description of key information

Acute oral toxicity: One reliable study is available. In this study [Costello, 1982] the LD50 (rat) was > 5000 mg/kg bw.
Acute dermal toxicity: One reliable study is available. In this study [Costello, 1984] the LD50 (rabbit) was > 2000 mg/kg bw.
Acute inhalation toxicity: No data are available for the inhalation route. The substance is a liquid with a vapour pressure of 3.5 x10-4 Pa at 25°C and is used primarily as a component of lubricants, greases by workers and consumers and metalworking fluids by workers. It is expected that inhalation exposure from these uses will be low and that the most likely route of exposure for workers and consumers is the dermal route.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
1 - Reliable Guideline study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
1 - Reliable Guideline study available

Additional information

Acute oral toxicity:

One reliable study is available. In this study the acute oral toxicity was investigated using a similar method to that given in 16 CFR 1500.3 of the Federal Hazardous Substances Act Regulations [Costello, 1982]. A group of ten (5 male and 5 female) albino rats (Sprague-Dawley) were dosed with 5000 mg/kg of the test material by oral gavage. The animals were observed for 14 days after test material administration for signs of toxicity and mortalities. Gross autopsies were performed on all animals that either died within the 14 day observation period or on surviving animals. There were no mortalities or signs of clinical toxicity. The acute oral LD50 in male and female rats is > 5000 mg/kg bw.

Acute dermal toxicity:

One reliable study is available. In this study, performed using a similar method to that given in 16 CFR 1500.4 of the Federal Hazardous Substances Act Regulations [Costello, 1984] a single dose of 2 g/kg undiluted test material was applied to the shaved backs of ten New Zealand White rabbits (5 males and 5 females). The skin of five animals (2 males and 3 females) was abraded prior to dosing. The test material was covered with an occlusive dressing for a period of 24 hours. At the end of the exposure period, the treated area was wiped to remove any residual test material. The animals were observed for deaths or overt signs of toxicity daily for 14 days. The sites were also examined for evidence of primary irritation daily for 14 days. Individual bodyweights were recorded prior to application of the test material at the start of the study and on days 7 and 14. At the end of the observation period all animals were euthanized and subjected to gross necropsy. There were no deaths or clinical signs of toxicity during the study. A loss of bodyweight was noted for one female at 14 days, all other animals showed expected gains. Mild to moderate erythema was observed in all animals after the 24 hour exposure and by day 4 of the observation period all animals exhibited eschar which persisted through day 14 of the study. Gross pathological examination showed no formed fecal material and spongy kidneys in the female that lost weight. No abnormalities were noted in the other animals. The dermal LD50 of the test material in male and female rabbits was determined to be > 2000 mg/kg bw.

Acute inhalation toxicity:

No data are available for the inhalation route. The substance is a liquid with a vapour pressure of 3.5 x10-4Pa at 25°C and is used primarily as a component of lubricants, greases by workers and consumers and metalworking fluids by workers. It is expected that inhalation exposure from these uses will be low and that the most likely route of exposure for workers and consumers is the dermal route.

Justification for classification or non-classification

Acute oral toxicity:

An acute oral toxicity study performed using a similar method to that given in 16 CFR 1500.3 of the Federal Hazardous Substances Act Regulations resulted in a LD50 > 5000 mg/kg bw [Costello, 1982]. On the basis of this study classification for acute oral toxicity is not required.

Acute dermal toxicity:

An acute dermal toxicity study performed using a similar method to that given in 16 CFR 1500.4 of the Federal Hazardous Substances Act Regulations resulted in a LD50 > 2000 mg/kg bw [Costello, 1984]. On the basis of this study classification for acute dermal toxicity is not required.

Acute inhalation toxicity:

No data are available. Testing was not performed as the dermal route was considered to be the most likely route of exposure.