Registration Dossier

Administrative data

Description of key information

Oral:
Single doses of 5.0 g/kg of the test material diluted in peanut oil at a concentration of 714 mg/ml were administered intragastrically to five fasted male and female rats. No mortality was observed. No signs of toxicity were observed.
The gross pathological and histopathological changes observed were spontaneous and unrelated to treatment with the test material.
The LD50 was considered to be >5 g/kg (>5000 mg/kg) based on the results.
Dermal:
The test article, when administered dermally to 5 male and 5 female New Zealand white rabbits had an acute dermal LD50 of greater than 5 g/kg when administered as an 80% suspension of test material in mineral oil (>4 g/kg test material).

Key value for chemical safety assessment

Additional information

Oral:

Value for CSA: >5000 mg/kg

In the key study for oral exposure (Brorby, 1986, Report number: SOCAL 2326) there was no mention of what guideline was followed, however the methodology suggests that it was conducted similarly to OECD 401. The study was conducted in line with GLP. A reliability rating of 1 according to the criteria of Klimisch, 1997. This was considered to be the most reliable study. Also of all the endpoints, this study gave the lowest LD50 (>5000 mg/kg) which is more appropriate for classification purposes.

There are also the following supporting studies for this endpoint:

- The Meyding et al study, 1962a (Hazleton report number: 20-0169-33) was not considered the key study as it was conducted less recently than the above key study and was not conducted according to a recognised guideline or GLP. Satisfactory methods and results are presented. The study was considered to have a reliability rating of 2, according to the criteria of Klimisch, 1997.

The acute oral LD50 of the test material for male albino rats is greater than 16.1 g/kg of body weight.

- The Meyding et al study, 1962b (Hazleton report number: 20-0169-33) was not considered the key study as it was conducted less recently than the above key study and was not conducted according to a recognised guideline or GLP. Satisfactory methods and results are presented. The study was considered to have a reliability rating of 2, according to the criteria of Klimisch, 1997.

The acute oral LD50 of the test material for male albino rats is greater than 19.3 g/kg of body weight.

- The Unpublished, 1975 study was not considered the key study as it was conducted less recently than the above key study and was obtained from the peer reviewed, 2006 OECD SIDS dossier due to the original report being unavailable. A reliability rating of 4 was assigned according to the criteria of Klimisch, 1997.

LD50 > 5000 mg/ kg b. wt. (males and females).

Dermal:

Value for CSA: >4000 mg/kg

In the key study for dermal exposure (Brorby, 1986; Report number: SOCAL 2327) there was no mention of what guideline was followed, however the methodology suggests that it was conducted similarly to OECD 402. The study was conducted in line with GLP. A reliability rating of 1 according to the criteria of Klimisch, 1997. This was considered the most reliable study.

The acute dermal LD50 of the test material was considered to be >5 g/kg when administered as an 80% suspension in mineral oil (>4 g/kg test material).

There are also the following supporting studies for this endpoint:

- The Meyers, 1986 study was not considered the key study as it was conducted less recently than the above key study, was conducted on abraded skin and the information was obtained from the peer reviewed, 2006 OECD SIDS dossier due to the original report being unavailable. A reliability rating of 4 was assigned according to the criteria of Klimisch, 1997.

In an acute dermal toxicity study with the test material a single limit dose of 2.0 g/kg was applied to the abraded skin of five male and five female rabbits for 24 hours. There were no deaths, and no signs of systemic toxicity were observed during the 14-day observation period. The acute dermal LD50 was > 2.0 g/kg.

- The Meyding et al study, 1962b (Hazleton report number: 20-0169-33) was not considered the key study as it was conducted less recently than the above key study and was not conducted according to a recognised guideline or GLP. Satisfactory methods and results are presented. The study was considered to have a reliability rating of 2, according to the criteria of Klimisch, 1997.

The acute dermal LD50 of the test material for rabbits is greater than 15 g/kg of body weight.

- The Meyding et al study, 1962a (Hazleton report number: 20-0169-33) was not considered the key study as it was conducted less recently than the above key study and was not conducted according to a recognised guideline or GLP. Satisfactory methods and results are presented. The study was considered to have a reliability rating of 2, according to the criteria of Klimisch, 1997.

The acute dermal LD50 of the test material for rabbits is greater than 15 g/kg of body weight.

Inhalation:

In a supporting study for inhalation exposure (Rittenhouse et al, 1985, Report number: SOCAL 2323) there was no mention of what guideline was followed, however the methodology suggests that it was conducted similarly to OECD Guideline 403 (Acute Inhalation Toxicity). The study was conducted in line with GLP. A reliability rating of 2 according to the criteria of Klimisch, 1997.

The study cannot be used to assign classification to the substance according to the current EU criteria as the animals were exposed for only 1 hour as opposed to the 4 hour described in Directive 67/548/EEC. There were no signs of mortality during the study and consequently the LC50 was determined to be > 1.67 mg/L (males and females).

In accordance with column 2 of REACH Annex VIII, section 8.5.2, it is considered justifiable to omit the acute toxicity: inhalation study. The substance only exists in liquid form and it will not 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.