3,3,5,7,7-pentamethyl-1,2,4-trioxepane

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

yes

Remarks:

There were temporary deviations from the minimum level of relative humidity. Evaluation: laboratory historical data do not indicate an effect of the deviations. he study integrity was not adversely affected by the deviations.

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

no

Test material

Reference

Name:

Unnamed

Type:

Constituent

Test material form:

liquid

Specific details on test material used for the study:

Clear colourless liquid, purity 96.5%.

Test animals

Species:

rat

Strain:

Wistar

Remarks:

Wistar Crl / WI (outbred SPF quality)

Sex:

female

Details on test animals or test system and environmental conditions:

Nine femailes, age 9-10 weeks

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

Single dosage on day 1

Doses:

2000 mg/kg (2.17 ml/kg) body weight
300 mg/kg (0.326 ml/kg) body weight

No. of animals per sex per dose:

3

Details on study design:

Post dose observation period: 14 days

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

300 - 2 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Key result

Sex:

female

Dose descriptor:

LD50 cut-off

Effect level:

500 mg/kg bw

Based on:

test mat.

Mortality:

Number of deaths at each dose level:

2000 mg/kg 3/3
300 mg/kg 0/3
300 mg/kg 1/3

Clinical signs:

2000 mg/kg
Restless behaviour, lethargy, hunched posture, tremors (general), uncoordinated movements, laboured respiration, piloerection, ptosis and/or chromodacryorrhoea.

300 mg/kg
lethargy, restless behaviour, hunched posture, shallow respiration, quick breathing, piloerection, swelling of the snout and/or ptosis.

Other findings:

Necropsy findings:
Macroscopic post mortem examination of the animals treated at 2000 mg/kg revealed many dark red foci in the lungs and thymus and pale discolouration of the stomach.
No abnormalities were found in the animals dosed at 300 mg/kg.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

The oral LD50 value of pentamethyl-trioxepane in Wistar rats was established to be within the range of 300-2000 mg/kg bw. According to the OECD guideline 423 the LD50 cut-off value was considered to be 500 mg/kg bw.

Executive summary:

The oral LD50 value of pentamethyl-trioxepane in Wistar rats was established to be within the range of 300-2000 mg/kg bw.

Data are conclusive and the substance is classified as Category 4 based on GHS criteria.