2,2-dimethyl-3-(3-methylpenta-2,4-dienyl)oxirane

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1979

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Pre-GLP study following a method equivalent to a recognised guideline at a limit dose, with some deviations not expected to affect the reliability of the study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

Limit dose of 5000mg/kg bw applied single dose; all male rat species, no gross pathology completed.

Principles of method if other than guideline:

The principles of the method were in accordance with the US 16 CFR 1500.3 definitions.

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2,2-dimethyl-3-(3-methylpenta-2,4-dienyl)oxirane

EC Number:

273-870-4

EC Name:

2,2-dimethyl-3-(3-methylpenta-2,4-dienyl)oxirane

Cas Number:

69103-20-4

Molecular formula:

C10H16O

IUPAC Name:

2,2-dimethyl-3-(3-methylpenta-2,4-dienyl)oxirane

Test material form:

other: liquid

Details on test material:

- Physical state: liquid

Test animals

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Recognised animal supplier
- Age at study initiation: 8 weeks
- Weight at study initiation: 208 - 232 g
- Fasting period before study: not reported
- Housing: The animals were housed 5/cage in suspended wire mesh cages· (20" x 10" x 7").
- Diet: rat chow ad libitum
- Water: ad libitum
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 21
- Humidity (%): not reported
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): not reported

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

The test material was given orally by syringe and 13 gauge blunt end needle. One group of ten male rats were: dosed at 5000 mg/kg of body weight. For liquid materials, the dose was based on the sample weight as calculated from the specific gravity.

Doses:

5000 mg/kg

No. of animals per sex per dose:

10 males

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The rats were observed 3-4 hours after dosing and once daily for 14 days.
- Necropsy of survivors performed: no

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

One animal died on day 1.

Clinical signs:

other: Lethargy, ataxia and ptosis were noted in five or more animals 3-4 hours post dose. Isolated instances of prostration and negative righting reflex were noted 3-4 hours post dose. Lethargy, ptosis, piloerection and chromorhinorrhea were noted in five or mo

Gross pathology:

Not examined

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: US CPSC / US FDA

Conclusions:

Under the conditions of this study the LD50 was determined to be > 5000 mg/kg in male wistar rats.

Executive summary:

The pre-GLP study was performed following a method similar to OECD 401 to assess the acute oral toxicity potential of the test substance to male Wistar rats. The test material was administered as a single oral dose to a group of 10 male rats orally, at a dose level of 5000 mg/kg bodyweight. All animals were observed for a fourteen day period for any signs of toxicity or other effects of treatment. Animals were not examined for gross pathology. One animal died on Day 1 at this dose level. Lethargy, ataxia and ptosis were noted in five or more animals 3-4 hours post dose. Isolated instances of prostration and negative righting reflex were noted 3-4 hours post dose. Lethargy, ptosis, piloerection and chromorhinorrhea were noted in five or more animals on Days 1 and 2 and periodically through to Day 5. All surviving animals were normal on Day 6. Isolated instances of lethargy, ptosis, and chromorhinorrhea were sporadically noted on Days 7 through to 14. Under the conditions of this study the LD50 was determined to be >5000 mg/kg.