cis-hex-3-en-1-yl methyl carbonate

Endpoint summary

Description of key information

Acute oral (OECD TG 401): > 5000 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:

22 May 1979 - 30 July 1979

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

not specified

Remarks:

The study was done in a GLP lab.

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Breeding Laboratories, Inc., Wilmington, Massachusetts.
- Weight at study initiation: males: 185 to 210g; females: 172 to 187g
- Fasting period before study: Overnight until one hour after dosing.
- Housing: Individually housed in suspended stainless steel wire-mesh bottom cages.
- Diet: Free access to Purina Rodent laboratory Chow #5001
- Water: Free access to water
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
No data.

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw.

DOSAGE PREPARATION: Based on a specific gravity of 0.9754, appropriate amounts of the test substance were admixed with corn oil to achieve the required dose levels. Dosing solutions were agitated prior to administration.

CLASS METHOD
- Rationale for the selection of the starting dose: A preliminary range-finding study was performed to select dose levels for the LD50 phase of the experiment. The test substance was diluted in corn oil and administered to five groups of two male and two female rats, each, at levels of 5000, 1600, 500, 160 and 50 mg/kg bw. All animals were observed daily for three days of mortality. All rats surviving on Day 4 were sacrificed and discarded.

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: The animals were observed for signs of toxicity and mortality at 1, 3, 6 and 24 hours after dosing and daily thereafter for 14 days.
- Body weights: Individual body weights were recorded prior to dosing and at the time of sacrifice on Day 14.
- Necropsy of survivors performed: yes, all animals on Day 14 were sacrificed using CO2 exposure. Necropsies were performed on all animals at the time of sacrifice.

Statistics:

Not performed.

Preliminary study:

No deaths occurred in any treatment groups. No signs of test substance induced toxicity were observed in animals administered 500 or 5000 mg/kg bw. Singular incidences of soft feces were observed in females receiving 50 and 160 mg/kg bw, and this finding was noted in one male receiving 1600 mg/kg bw at four and six hours after dosing.

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred.

Clinical signs:

other: No signs of test substance induced toxicity were observed in any of the animals.

Gross pathology:

Sacrifice and gross examination of the animals on Day 14 revealed only mottled lungs which are considered to be an artifact of exposure to CO2. No gross tissue alterations attributable to treatment with the substance were observed in any of the animals.

Interpretation of results:

other: Not acute harmful.

Remarks:

According to Regulation (EC) No. 1272/2008.

Conclusions:

The acute oral toxicity test with the substance showed an LD50 of >5000 mg/kg bw. Based on this result the substance is not acute harmful.

Executive summary:

In this study performed equivalent to OECD TG 401 guideline and performed in a GLP facility, 20 rats (10 males and 10 females) were administered with the substance at a dose level of 5000 mg/kg bw. None of the animals died. No abnormal clinical signs were observed. Gross pathological examinations at 14 days p.a. (terminal necropsy) revealed no test article dependent findings. Based on the results in this study, the substance is not acute harmful and the acute oral LD50 for the substance in male and female rats was determined to be >5000 mg/kg bw.

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:

In this study performed equivalent to OECD TG 401 guideline and performed in a GLP facility, 20 rats (10 males and 10 females) were administered with the substance at a dose level of 5000 mg/kg bw. None of the animals died. No abnormal clinical signs were observed. Gross pathological examinations at 14 days p.a. (terminal necropsy) revealed no test article dependent findings. Based on the results in this study, the substance is not acute harmful and the acute oral LD50 for the substance in male and female rats was determined to be >5000 mg/kg bw.

Justification for classification or non-classification

Based on the results in this study, the substance does not have to be classified for acute toxicity by the oral route according to Regulation (EC) No. 1272/2008 and its updates.