Registration Dossier

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 levelsopen allclose all
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
300 - 2 000 mg/kg bw
Based on:
test mat.
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.