Tetrakis(2-butoxyethyl) orthosilicate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

22 January to 11 February 1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Tetrakis(2-butoxyethyl) orthosilicate

EC Number:

242-560-0

EC Name:

Tetrakis(2-butoxyethyl) orthosilicate

Cas Number:

18765-38-3

Molecular formula:

C24H52O8Si

IUPAC Name:

tetrakis(2-butoxyethyl) orthosilicate

Test animals

Species:

rat

Strain:

other: Bor: WISW (SPF cpb)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Fa. Winkelmann
- Age at study initiation: 6-8 weeks
- Weight at study initiation: Each animal's body weight deviated no more than 20% from the group mean. No further detail.
- Fasting period before study: 16 hours.
- Diet: Discontinued 16 hours before treatment, and restarted three hours after treatment. Otherwise ad libitum.
- Water: ad libitum
- Acclimation period: Five days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20± 3
- Humidity (%): 30-70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

No further details.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

Five

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations for clinical signs: 0.5, 1, 2, 3, 4, 5 and 6 hours, and then daily up to two weeks post-exposure.
- Necropsy of survivors performed: yes
- Other examinations performed: no data

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Remarks on result:

other: No deaths

Mortality:

No deaths occurred.

Clinical signs:

There were no clinical signs of toxicity.

Body weight:

No effect on body weight.

Gross pathology:

Reddening of the small bowel mucosa in one male animal. There were no macroscopic changes in the other nine animals.

Other findings:

No other findings.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In a good quality OECD 401 study that was conducted to GLP, no deaths followed a limit dose of 2000 mg/kg bw by oral gavage to five male and five female rats.

Executive summary:

In a GLP study conducted in accordance with the now deleted OECD TG 401, five male and five female rats were given a single limit dose of 2000 mg/kg bw test material by oral gavage, and observed for two weeks. All animals were examined macroscopically. No deaths or clinical signs were observed in any of the animals. Reddening of the small bowel mucosa in one male rat was reported, but there were no macroscopic changes in the other nine animals. The LD₅₀ was therefore >2000 mg/kg bw.