1,3-dimethylbut-3-enyl isobutyrate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

December 06, 1979

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study was performed prior to the OECD Test Guideline No. 401 but the protocol is similar to that guidance.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: US FHSA CFR 1500.3 (HSLA)

Deviations:

no

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

(environmental conditions not reported)

Principles of method if other than guideline:

Acute gavage administration to rats.

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1,3-dimethylbut-3-enyl isobutyrate

EC Number:

279-399-0

EC Name:

1,3-dimethylbut-3-enyl isobutyrate

Cas Number:

80118-06-5

Molecular formula:

C10H18O2

IUPAC Name:

4-methylpent-4-en-2-yl 2-methylpropanoate

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): MT-102.Methylpentenol isobutyrate
- Physical state: Clear colorless liquid
- Density: 0.90 g/mL

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Blue Spruce Farms, Inc., Altamont, NY.
- Weight at study initiation: 183-225 g
- Fasting period before study: Animals were fasted overnight (ca. 18 h) prior to oral intubation.
- Housing: Animals were housed in wire mesh bottom cages in rooms with temperature control.
- Acclimation period: ca. 2 weeks

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: no data

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: Animals were observed three times a day on the day of dosing, twice daily on Day 1 and once daily for the remainder of the study. All gross or visible toxic or pharmacological effects were recorded.
- Necropsy of survivors performed: no; all animals that died during the study were subjected to a complete gross necropsy.

Statistics:

None

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: one of ten animals died on day 2 post dosing

Mortality:

One of ten animals died on day 2 post dosing. The 95 % confidence interval for this 10 % rate of mortality is 0 to 40 % when the test material was administered to rats orally at a level of 5000 mg/kg bw.

Clinical signs:

other: - Diarrhea was observed in 3/5 females; ataxia in 4/5 male and 5/5 female animals; decreased activity in all animals

Gross pathology:

- No abnormalities were noted at necropsy except pale lungs, mottled liver, pale kidneys and small & granular spleen were observed in one male.

Other findings:

None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Oral LD50 Combined > 5000 mg/kg bw

Executive summary:

In an acute oral toxicity study (limit test) performed similarly to OECD Guideline No. 401 and in compliance with GLP, groups (5/sex/dose) of Sprague-Dawley rats were given a single oral (gavage) dose of test material at 5000 mg/kg bw. Animals were then observed for mortality, clinical signs and bodyweights for 14 days and all the animals that died during the study were sacrificed for macroscopic examination.

One of ten animals died on day 2 post dosing. Diarrhea was observed in 3/5 females; ataxia in 4/5 male and 5/5 female animals; decreased activity in all animals. Surviving animals showed expected gains in bodyweight over the 14-day study period. No abnormalities were noted at necropsy except pale lungs, mottled liver, pale kidneys and small & granular spleen were observed in one male.

Oral LD50 Combined > 5000 mg/kg bw.

 

Under the test conditions, the test material is not classified for acute oral toxicity according to the annex VI of the Regulation EC No. 1272/2008 (CLP).

This study is considered as acceptable and satisfies the requirement for acute oral toxicity endpoint.