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Administrative data

Description of key information

The acute oral LD50 of the test material in rats is > 6000 mg/kg bw.

The acute oral LD50 of the test material in hamsters is > 3000 mg/kg bw.

The inhalation LC50 of the test material in rats is > 2119 mg/m³ air.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
6 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating conc.
Value:
2 mg/m³

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Oral:

Two acute oral toxicity studies were performed.

- In an acute oral toxicity study comparable to OECD guideline 401 (CIBA-GEIGY, 1978) the test material was evaluated in (7 to 8 weeks old) healthy random bred rats of the Tif: RAIf (SPF) strain. Animals fasted overnight were treated by oral intubation, in groups of five per dose level (4000, 5000, 6000 mg/kg bw). Physical condition and rate of deaths were monitored throughout a 14-day observation period. Animals in all three dose groups showed sedation, dyspnoea, exopthalmos, ruffled fur, body position (curved) and recovered within 10 days. No death occurred and no substance related gross organ changes were seen. The acute oral LD50 of the test material is > 6000 mg/kg bw. The test material has therefore practically no acute toxicity to the rat by this route of administration.

- In an acute oral toxicity study comparable to OECD guideline 401 (CIBA-GEIGY, 1981) the test material was evaluated in 9-11 week old Chinese hamsters of both sexes. Animals fasted overnight were treated orally, with a single dose (3000 mg/kg), by means of a stomach tube. Physical condition and rate of deaths were monitored throughout a 14 day observation period. No deaths occurred. Animals were slightly sedated, showed slight dyspnoea, ruffled furr and body position (curved). The animals recovered within 6 days. All animals were submitted to a necropsy, no gross organ changes were seen. The acute oral LD50 is greater than 3000 mg/kg. The test material has therefore practically no acute toxicity to the Chinese hamster by this route of administration.

Inhalation:

In an inhalation study comparable to OECD guideline 403 (CIBA-GEIGY, 1980) rats of the Tif: RAIf (SPF) strain (10/sex/dose) were administered the test material (1365± 47 mg/m³, 2119±168 mg/m³) by inhalation for 4 hours followed by a 14-day observation period. No death occurred. Overall body weights and weight gains were within normal limits when measured at day 7 and 14 of the observation period. The surviving animals recovered within 7 to 8 days after the exposure period. Slight dyspnoea, exophthalmus, ruffled fur, and curved body position were noted during and after exposure to 1365 and 2119 mg/m³ of the test material. No gross pathology was noted in the control or either treatment groups at necropsy. The LC50 was > 2119 mg/m³ air.

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 toxicity under Directive 67/548/EEC.

                               

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 toxicity under Regulation (EC) No. 1272/2008.