Registration Dossier

Administrative data

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

Referenceopen allclose all

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:
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.

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:
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 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
5 000 mg/kg bw

Additional information

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.