Registration Dossier

Administrative data

Description of key information

The substance did not cause adverse effects upon a single oral dose of 10000 mg/kg bw  in rats in a study design similar to that of OECD guideline 423 (BASF 1973). It did not cause acute dermal toxicity at the limit dose of 2000 mg/kg bw in a GLP compliant study following OECD guideline 402 (BASF 2012a).

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
10 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 000 mg/kg bw

Additional information

The acute oral LD50 in rats of both sexes observed over a period of 7 days is greater than 10'000 mg/kg (BASF 1973). The study was performed prior to the introduction of GLP but is reported in adequate detail for evaluation. The design deviates from the OECD testing guideline in the higher dose and the shorter observation period. Considering that none of the animals showed severe signs of toxicity at 6000 or 10000 mg/kg bw, the shorter duration is an acceptable deviation. The test item was suspended at 50 % with carboxymethyl-cellulose 2 % and administered by oral intubation to each male and females per dose group. Within 2 hours after treatment the rats in both dosage groups showed dyspnoea, exophthalmus, curved position and ruffled fur. These symptoms became more accentuated as the dose was increased. The animals had recovered within 3 to 6 days. They were killed and autopsied after an observation period of 7 days, no substance related gross organ changes were seen.

In the acute dermal toxicity study, young adult Wistar rats (5 males and 5 females) were dermally exposed to a single dose of 2000 mg/kg bw (as suspension in olive oil Ph.Eur.) to the clipped skin (dorsal and dorsolateral parts of the trunk) and covered by semi-occlusive dressing for 24 hours (BASF 2012a). The study followed GLP and OECD testing guideline 402. The application area comprised at least 10% of the total body surface area. The animals were observed for 14 days.

No mortality occurred. No signs of systemic toxicity effects occurred. The mean body weight of the male animals increased within the normal range throughout the study period. The mean body weight of the female animals did not adequately increase during

the first post-exposure observation week, probably due to the bandage procedure, but increased during the second week within the normal range. No macroscopic pathologic abnormalities were noted in the animals examined at the end of the study. Red discoloration by the test item of the application area and test item residues were found at the end of the observation period.

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for acute oral or dermal toxicity under Directive 67/548/EEC, as amended for the 31st time in Directive2009/2/EG.

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for acute oral or dermal toxicity under Regulation (EC) No. 1272/2008, as amended for the third time in Directive EC 618/2012.