Reaction mass of Benzeneethanol, 2-chloro-α-(1-chlorocyclopropyl)-α-(chloromethyl)- and Oxirane, 2-(1-chlorcyclopropyl)-2-[(2-chlorphenyl)methyl]-

Endpoint summary

Description of key information

Under the test conditions (according to OECD TG 423), the acute oral LD50 of the test item for male and females rats was determined to be > 2500 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

March 2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Specific details on test material used for the study:

- Solubility and stability of the test substance in the solvent/vehicle: Stability of the test substance in the formulation for administration was confirmed analytically.
- Treatment of test material prior to testing: The test substance was formulated in Polyethylenglycol 400 before administration.For the formulation the actual content of the test substance was considered. The
applied formulations were well mixed before and during administration, and by pumping the syringe several times.

Species:

rat

Strain:

Wistar

Sex:

male/female

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Details on oral exposure:

The test substance was administered per os in a single dose by stomach tube to fasted male and female rats (fasted for approx. 17 hours + 1 hour). A volume of 5 ml/kg body weight was administered.

Doses:

2000 mg/k bw

No. of animals per sex per dose:

3

Control animals:

yes

Statistics:

not applicable

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 500 mg/kg bw

Based on:

act. ingr.

Mortality:

one female died on day 3.

Clinical signs:

other: At 2,000 mg/kg body weight piloerection, decreased motility, uncoordinated gait, narrowed palpebral fissures (in males temporary), and diarrhea were observed in both sexes. Additionally, constipation and decreased reactivity were observed in all females,

Gross pathology:

In animals that died during the observation period the following changes were detected: Liver, pale discoloration, spotted.
No gross pathologic changes were observed in animals sacrificed at the end of the study period.

Interpretation of results:

GHS criteria not met

Executive summary:

Under the test conditions (according to OECD TG 423), the acute oral LD50 of the test item for male and females rats was determined to be > 2500 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 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 study available

Justification for classification or non-classification

Based on the study results a classification according to Directive 67/548/EEC or Regulation (EC) No. 1272/2008 (CLP) is not warranted.