3,3'-(1,1,3,3-tetramethyldisiloxane-1,3-diyl)bispropylamine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1984-02-11 to 1984-03-11

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Remarks:

Two male rats used per group. Tested doses were 500 and 5000 mg/kg bw. Environmental conditions not specified. No rationale for dose selection. No data on post-mortem examinations, clinical signs or body weights.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

no guideline available

GLP compliance:

yes

Test type:

other: Single oral gavage administration of 5000 and 500 mg/kg bw to two male rats per dose per group.

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

3,3'-(1,1,3,3-tetramethyldisiloxane-1,3-diyl)bispropylamine

EC Number:

219-588-7

EC Name:

3,3'-(1,1,3,3-tetramethyldisiloxane-1,3-diyl)bispropylamine

Cas Number:

2469-55-8

Molecular formula:

C10H28N2OSi2

IUPAC Name:

3,3'-(1,1,3,3-tetramethyldisiloxane-1,3-diyl)bispropylamine

Test material form:

liquid

Specific details on test material used for the study:

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: no data
- Stability under test conditions: no data
- Solubility and stability of the test substance in the solvent/vehicle: no data
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: no data

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: no data
- Preliminary purification step (if any): no data
- Final dilution of a dissolved solid, stock liquid or gel: the test substance was used undiluted

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Cherles River, Canada
- Females (if applicable) nulliparous and non-pregnant: not applicable
- Age at study initiation: young adult
- Weight at study initiation: 222 - 292 grams at study initiation
- Fasting period before study: no data
- Housing: individual hanging wire-mesh cages
- Diet (e.g. ad libitum): Purina Certified Rodent Chow #5002
- Water (e.g. ad libitum): no data
- Acclimation period: 30 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: dose volume not specified

DOSAGE PREPARATION (if unusual): not applicable

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: not specified

Doses:

500 and 5000 mg/kg bw

No. of animals per sex per dose:

2 males

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Every hour for the first 4 hours, then daily for 14 days. Body weight records were not reported.
- Necropsy of survivors performed: not specified
- Other examinations performed: clinical signs were not reported.

Statistics:

Not used.

Results and discussion

Effect levels

Key result

Sex:

male

Dose descriptor:

LDLo

Effect level:

500 mg/kg bw

Based on:

test mat.

Mortality:

Both animals treated with 500 mg/kg bw/day died on day 2 post-administration. Both animals treated with 5000 mg/kg bw died within 4 hours after administration.

Clinical signs:

None reported.

Body weight:

None reported.

Gross pathology:

None reported.

Other findings:

None reported.

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Conclusions:

In the acute toxicity study, conducted according to a protocol similar to OECD 423 and in compliance with GLP, the reported LDLo value was concluded to be 500 mg/kg bw.