Reaction mass of (R)-cyano(3-phenoxyphenyl)methyl rel-(1R,3R)-3-((1Z)-2-chloro-3,3,3-trifluoroprop-1-en-1-yl)-2,2-dimethylcyclopropanecarboxylate and (R)-cyano(3-phenoxyphenyl)methyl rel-(1S,3S)-3-((1Z)-2-chloro-3,3,3-trifluoroprop-1-en-1-yl)-2,2-dimethylcyclopropanecarboxylate

Endpoint summary

Description of key information

LD50 (rat, oral)=166 mg/kg bw in males and 114 mg/kg bw in females (Pritchard, 1984)
LD0 (rat, dermal) =200 mg/kg bw in female rats, LD0 (rat, dermal)=1000 mg/kg bw in male rats (Nixon, 1981)
LD50 (rabbit, dermal) > 2 mL/kg bw in both sexes (Nixon, 1981)

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Dose descriptor:

LD50

Value:

114 mg/kg bw

Additional information

Four studies reports are available for the determination of the acute oral toxicity.

Only one study (Pritchard, 1984) has been considered reliable (with minor restrictions) and adequate for the purposes of risk assessment, classification and labeling.

The study conducted on rats (Nixon, 1981) has been considered as supporting study and both the studies on mouse (Nixon, 1981) and guinea pig (Nixon, 1981) have been considered as disregarded studies based on Klimisch rating and because adequate data in the rat is available.

Four studies reports are available for the determination of the acute dermal toxicity.

All the studies have been considered for their reliability, and while on a formal rating may be evaluated to have deviations and therefore be of low reliability, taken into consideration together they do provide a comprehensive weight of evidence.

A weight of evidence approach was taken therefore and the LD50 >200 mg/kg bw (where LD0=200 mg/kg bw in female rats) has been chosen as conservative “worst case value” for the purposes of risk assessment, classification and labeling.

No data on acute inhalation toxicity.

A study on acute toxicity to rats determined by intraperitoneal application (Nixon, 1981) is cited but considered not reliable because insignificant route of exposure.

Justification for classification or non-classification

Based upon the classification criteria according to the Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008, the test item has to be classified as Toxic Category III for acute oral and dermal route.

The value for the acute oral toxicity, LD50=114 mg/kg bw does lead to the classification of the substance as R25, Toxic if swallowed, according to the criteria in Directive 2001/59/EC, Annex VI, 3.2.

The value for the acute dermal toxicity in female rat, LD50>200 mg/kg bw does lead to the classification of the substance as R24, Toxic in contact with skin according to the criteria in Directive 2001/59/EC, Annex VI, 3.2.