Ethyl 3-phenyloxirane-2-carboxylate

Endpoint summary

Description of key information

Acute oral toxicity (similar to OECD TG 401): 2300 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:

November - December, 1972

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Remarks:

Pre-OECD test guideline study and pre-GLP

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Species:

rat

Strain:

other: Sherman-Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: no data
- Three males and two females of the Sherman-Wistar strain.
- Fasting period before study: 24 hours
- Diet: Free access to food
- Water: Free access to water
- Acclimation period: one week

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 3.16 mL/kg bw

Doses were administered directly into the stomach by means of a stomach tube. The substance was applied as a 4% solution, the toxicity was converted to 100% substance.

Doses:

1.26, 1.6, 2.0, 2.5 and 3.16 mL/kg bw

No. of animals per sex per dose:

Three males and two females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: Daily
- Necropsy of survivors performed: No data

Key result

Sex:

male/female

Dose descriptor:

LD50

Remarks:

the LD50 is converted to the pure substance

Effect level:

2 300 mg/kg bw

Based on:

test mat.

Remarks on result:

other: Confidence limits 2000 - 2600 mg/kg.

Mortality:

1/5 animals died at 2.0 mL/kg bw, 4/5 animals died at 2.5 mL/kg bw and all 5 animals died at 3.16 mL/kg bw.

Clinical signs:

No data.

Body weight:

No data.

Gross pathology:

No data.

Interpretation of results:

other: Not acute harmful.

Remarks:

According to EU CLP Regulation (EC) No. 1272/2008 and its amendments

Conclusions:

The LD50 is 2300 mg/kg bw and based on this result, the substance is not acute harmful. According to GHS the substance needs to be classified for acute oral toxicity category 5 and labelled with H303: May be harmful if swallowed.

Executive summary:

In an acute oral toxicity study performed equivalent to OECD 401 guideline, five groups of rats (three males and two females) were orally exposed to a 4% solution of the substance. When converted to 100% substance the doses were 2 – 3.16 ml/kg bw. The rats were observed for signs of toxicity for a period of 14 days. 1/5 animals died at 2.0 mL/kg bw, 4/5 animals died at 2.5 mL/kg bw and all 5 animals died at 3.16 mL/kg bw, resulting in an LD50 of 2.3 mL/kg bw. This will value will be conservatively converted into 2300 mg/kg bw (In view of the relative density of the substance: 1.125, the LD50 is actually 2588 mg/kg bw). Based on this result, the substance is not acute harmful.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

The acute oral toxicity result is of sufficient quality and adequate for this dossier.

Additional information

Acute oral toxicity:

In an acute oral toxicity study performed equivalent to OECD 401 guideline, five groups of rats (three males and two females) were orally exposed to a 4% solution of the substance. When converted to 100% substance the doses were 2 – 3.16 ml/kg bw. The rats were observed for signs of toxicity for a period of 14 days. 1/5 animals died at 2.0 mL/kg bw, 4/5 animals died at 2.5 mL/kg bw and all 5 animals died at 3.16 mL/kg bw, resulting in an LD50 of 2.3 mL/kg bw. This will value will be conservatively converted into 2300 mg/kg bw (In view of the relative density of the substance: 1.125, the LD50 is actually 2588 mg/kg bw). Based on this result, the substance is not acute harmful.

Justification for classification or non-classification

The substance does not have to be classified for acute toxicity by the oral route according to EU CLP (EC,1272/2008 and its amendments).