(Z)-hex-3-enyl isobutyrate

Endpoint summary

Description of key information

WoE appraoch based on the two Klimish 4 tests below :

- Acute Oral Toxicity Of Selected Flavor Chemicals, Drug And Chemical Toxicology, 3(3), 249-258 dated on 1980 _ LD50 (Oral) = 250000 ml/Kg bw

- Acute Oral toxicity in rats on Cis-3-Hexenyl Isobutyrate abstract_ dated on 1976_LD50 (Oral) > 5000 mg/Kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Reference 1

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1976

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

abstract

Remarks:

1 page summary

Qualifier:

according to guideline

Guideline:

other: no guideline specified on the 1 page study summary

GLP compliance:

no

Limit test:

yes

Specific details on test material used for the study:

No 76-1277, Cis-3-hexenyl isobutyrate

Species:

rat

Strain:

not specified

Sex:

not specified

Route of administration:

oral: unspecified

Vehicle:

not specified

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No death occurred

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 of HEXENYL-3-CIS ISOBUTYRATE in rat has been determined to be above 5'000 mg/Kg bw. Hence the GHS criteria are not met for classification.

Executive summary:

The LD50 of HEXENYL-3-CIS ISOBUTYRATE in rat has been determined to be above 5'000 mg/Kg bw. Hence the GHS criteria are not met for classification.

Reference 2

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1980

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

documentation insufficient for assessment

Qualifier:

according to guideline

Guideline:

other: see the protocole description in the field "Principle of method of other than guideline"

Principles of method if other than guideline:

Groups of ten animals, five males and five females, weighing 15 to 35 g for mice (Swiss Webster, Southern Animal Farms, Pratville,_ Alabama or BLU :Ha(1CR), Blue Spruce Farms, Altamont, New York) and 40 to 60 g for rats, (FDRL Strain, Waverly, New York) were fasted overnight prior to treatment . The test substance was administered by oral gavage as a solution or suspension in corn oil . The concentration of the test substance in corn oil was adjusted so that each group of,animals in a particular study received the same volume of solution with respect to body weight . Animals had free access to water at all times and to feed (Purina Laboratory Chow) following dosing .
Animals were closely observed for mortality and pharmacologic effects on the day of dosing and daily thereafter for a total of 14 observation days . Rats were weighed prior to dosing . LD50s were calculated by appropriate statistical methods, as determined by the data (see tabular citations) .

GLP compliance:

no

Limit test:

yes

Specific details on test material used for the study:

TEST MATERIAL
Name as stated in the report : 3-hexenyl isobutyrate

Species:

other: rats and mice

Strain:

other: Swiss Webster, Southern Animal Farms, Pratville,_ Alabama or BLU :Ha(1CR) and FDRL Strain, Waverly, New York

Sex:

male/female

Details on test animals or test system and environmental conditions:

weight: 15 to 35 g for mice 40 to 60 g for rats
Animals had free access towater at all times and to feed (Purina Laboratory Chow) following dosing .

Route of administration:

oral: gavage

Vehicle:

corn oil

Doses:

25,000 mg/kg

No. of animals per sex per dose:

1 dose per animal

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 25 000 mg/kg bw

Based on:

test mat.

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 of HEXENYL-3-CIS ISOBUTYRATE in rat is likely to be in excess of 25 0000 ml/Kg bw. Hence the GHS criteria are not met for classification.

Executive summary:

The LD50 of HEXENYL-3-CIS ISOBUTYRATE in rat is likely to be in excess of 25 0000 ml/Kg bw. Hence the GHS criteria are not met for classification.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Justification for classification or non-classification

The LD50 values of HEXENYL-3-CIS ISOBUTYRATE have been determined to be above 5'000 mg/Kg bw in the 2 tests mentionned above. Hence the GHS criteria are not met for any Acute Oral classification.