Bicyclo[3.1.1]hept-2-ene, 2,6,6-trimethyl-, phosphosulfurized

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1970

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1970

Report date:

1970

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

yes

Remarks:

substance was tested above the limit dose; males used instead of females; missing data on animals

Principles of method if other than guideline:

Study was conducted using a method equivalent to OECD Testing Guideline 423 and meets acceptable scientific standards. Groups of five animals received doses up to 10,000 mg/kg bw of the registered substance in ethanol and were observed for 14 days. Mortality and clinical signs were recorded, and a gross necropsy was performed. As a result, it is considered that the study is providing a sufficient amount of data to conclude regarding the acute toxicity of the registered substance.

GLP compliance:

no

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Bicyclo[3.1.1]hept-2-ene, 2,6,6-trimethyl-, phosphosulfurized

EC Number:

267-032-7

EC Name:

Bicyclo[3.1.1]hept-2-ene, 2,6,6-trimethyl-, phosphosulfurized

Cas Number:

67762-73-6

IUPAC Name:

Bicyclo[3.1.1]hept-2-ene, 2,6,6-trimethyl-, phosphosulfurized

Test material form:

other: Liquid

Details on test material:

- Name of test material (as cited in study report): EC 267-032-7
- Physical state: a viscous, pale yellow liquid with an unpleasant odor

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River
- Weight at study initiation: 209 - 245 g
- Fasting period before study: overnight

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

ethanol

Details on oral exposure:

20 % ethanol used as a solvent

Doses:

Five dosages ranging from 34.6 g to 10,000 mg/kg bw

No. of animals per sex per dose:

Five male rats per dose

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observed at one, four and 24 hours and then daily thereafter
- Necropsy of survivors performed: yes

Statistics:

None

Results and discussion

Effect levels

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

> 10 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no deaths observed

Mortality:

None

Clinical signs:

other: None

Gross pathology:

No gross alterations observed

Other findings:

None

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral median lethal dose (LD50) of the test substance in male Sprague-Dawley rats was estimated to be greater than 10,000 mg/kg body weight. The registered substance did not meet the criteria for classification according to Regulation (EC) No.1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures.

Executive summary:

Male sprague-dawley rats were orally exposed by oral intubation to different doses of the test substance by a method similar to OECD guideline 423. Five dosage levels were used ranging from 34.6 g to 10,000 mg/kg of body weight. After the 14 days observation period no clinical observations were noted and there were no deaths at any of the concentrations. No gross alterations were noted during necropsy of the animals. It was therefore estimated that the LD50 was greater than 10,000 mg/kg bw. The test substance did not meet the criteria for classification according to Regulation (EC) No.1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures.