Amino functional alkoxysilanes

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

2001

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: RCC Ltd., Switzerland
- Age at study initiation: males, 8 weeks, females 10 weeks
- Fasting period before study: 16-20 hours
- Housing: Groups of 3/sex, in Makrolon type-4 cages with standard softwood bedding
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 'Under laboratory conditions, after health examination. Only animals without any visible signs were used for thhhe study.'

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 /- 3
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 2 ml/kg bw

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3 males, 3 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days

- Frequency of observations and weighing: Mortality and viability were observed once daily during acclimatization period and 1, 2, 3 and 5 hours after test item administration on test day 1 and twice daily during days 2-15. Each animal was examined for changes in appearance and behaviour once daily during the acclimatization phase. 1, 2, 3 and 5 hours after test item administration on test day 1, and once daily during days 2-15. All abnormalities were recorded.

- Necropsy of survivors performed: yes

Statistics:

No statistical analysis was used.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No death occurred during the study.

Clinical signs:

other: In one female, ruffled fur and hunched posture were noted on test day 1. No clinical signs were evident from test day 2 until the end of the observation period.

Gross pathology:

No macroscopic findings were observed at necropsy.

Other findings:

None reported.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral toxicity study with N-ethyl-3-trimethoxysilyl-2-methyl-propanamine, conducted according to OECD Test Guideline 423 and in compliance with GLP, the LD50 value was concluded to be >2000 mg/kg bw.