Reaction products of ((5E)-5-ethylidenebicyclo[2.2.1]hept-2-ene and (5Z)-5-ethylidenebicyclo[2.2.1]hept-2-ene) and 2-methyl-1,3-butadiene, epoxidized

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. Minor deviations not deemed to impact the reliability of the study.

Cross-reference

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

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

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

Deviations:

yes

Remarks:

Absence of gross pathology and/or assessment in the other sex - not deemed to impact reliability of the study.

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reaction products of ((5E)-5-ethylidenebicyclo[2.2.1]hept-2-ene and (5Z)-5-ethylidenebicyclo[2.2.1]hept-2-ene) and 2-methyl-1,3-butadiene, epoxidized

EC Number:

942-422-6

Molecular formula:

Not applicable (a generic molecular formula cannot be provided for this specific UVCB substance)

IUPAC Name:

Reaction products of ((5E)-5-ethylidenebicyclo[2.2.1]hept-2-ene and (5Z)-5-ethylidenebicyclo[2.2.1]hept-2-ene) and 2-methyl-1,3-butadiene, epoxidized

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: 189 - 282g
- 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. Doses were selected at log intervals. Ten male rats were dosed at each level. For liquid materials, the dose was based on the sample weight as calculated from the specific gravity.

Doses:

1.73, 2.47, 3.51 and 5.0 g/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

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

3 100 mg/kg bw

Based on:

test mat.

95% CL:

> 2 600 - < 3 700

Mortality:

One animal died on day 1 at 1.73 g/kg bw.
Two animals died on day 1 at 2.47 g/kg bw.
Seven animals died on day 1 at 3.51 g/kg bw.

Clinical signs:

other: At 1.73 g/kg bw: Isolated instances of ptosis, chromorhinorrhea , chromodacryorrhea and piloerection were noted on the day of dosing and on days one and two. All animals appeared normal from Days 3 through 14 At 2.47 g/kg bw: Isolated instances of chromor

Gross pathology:

Not examined

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Remarks:

EU criteria not met

Conclusions:

Under the conditions of this study the LD50 was determined to be 3100 mg/kg bw 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 groups of 10 male rats orally, at dose levels of 1.73, 2.47, 3.51 and 5.0 g/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. Deaths occurred at all dose levels. Significant signs noted included ptosis, piloerection, chromorhinorrhea, chromodacryorrhea, diarrhea, lethargy, flaccid muscle tone, dyspnea and sensitivity to manipulation. The surviving animals appeared generally healthy during the second week of observation. Under the conditions of this study the LD50 was determined to be 3100 (C.I. 2600 - 3700) mg/kg bw.