Registration Dossier

Administrative data

Description of key information

McCollister et al, 1956, was conducted on rats (similar to OECD 401 guideline not under GLP conditions) and reported an acute oral LD50 value of 140 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
140 mg/kg bw

Additional information

Acute toxicity: oral

McCollister et al, 1956, was conducted in a similar manner to the OECD 401 guideline and was therefore allocated a reliability score of 2 because pre-GLP. The study was conducted on Rats and reported an acute oral LD50 value of 140 mg/kg bw.

Rowe et al, 1952, was also conducted in a similar way to OECD 401, however deviations were greater than McCollister et al, 1956, and so this study is presented as supporting information only. Rowe et al, 1952, reported an acute oral LD50 value of 146 mg/kg bw for male rats and 117 mg/kg bw for female rats, these results support the key value above. Rowe et al, 1952, also reported acute oral LD50 values for Mice (Female: 420 mg/kg bw), Rabbits (Female: 55 mg/kg bw), Chicks (Mixed sex: 79 mg/kg bw) and Guinea pigs (Mixed sex: 110 mg/kg bw).

Acute toxicity: inhalation

Rowe et al, 1952, was the only available information for this route of administration. The study was given a reliability score of 2 as the study was based upon a novel methodology. Groups of rats and groups of guinea pigs were exposued to vapour inhalation of the substance at test concentrations of 100, 200, 400, 800, 1000, 3000, 5000, 10000ppm for rats and 200ppm and 400ppm for guinea pigs. The exposure period varied from 0.02 to 16 hours.

An acute inhalation (4 hour) LC50 of >200ppm (equivalent to >1.54 mg/l) was set based upon acute toxic effects.

Acute toxicity: dermal

Based upon dermal data for other endpoints the substance is expected to be dermally absorbed and systemically toxic, however in the absence of any available acute dermal toxicity data it is not possible to assess the extent of acute toxicity via the dermal route at this time. As the substance is already classified for acute dermal toxicity and as no dermal exposure to the registered substance from the identified use is expected further testing for this endpoint is considered to be inappropriate.

Justification for classification or non-classification

The registered substance is currently classified as Acute Tox 3; Toxic if swallowed, Toxic in contact with skin, Toxic if inhaled, according to Annex VI of EC Regulation 1272/2008 and R23/24/25: Toxic by inhalation, in contact with skin and if swallowed according to Annex I of 67/548/EEC.

The information which is currently available supports this assessment therefore no changes to the acute toxicity classifications are proposed at this time.