1,3,5-tris[3-(trimethoxysilyl)propyl]-1,3,5-triazine-2,4,6(1H,3H,5H)-trione

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

1,3,5-tris[3-(trimethoxysilyl)propyl]-1,3,5-triazine-2,4,6(1H,3H,5H)-trione

EC Number:

247-465-8

EC Name:

1,3,5-tris[3-(trimethoxysilyl)propyl]-1,3,5-triazine-2,4,6(1H,3H,5H)-trione

Cas Number:

26115-70-8

Molecular formula:

C21H45N3O12Si3

IUPAC Name:

tris[3-(trimethoxysilyl)propyl]-1,3,5-triazinane-2,4,6-trione

Test material form:

liquid: viscous

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 200-300 g
- Fasting period before study: the rats were fasted overnight prior to dosing
- Housing: no data
- Diet: appropriate commercial diet, ad libitum
- Water: municipal water, ad libitum
- Acclimation period: no data

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:

other: stomach intubation

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 16 mL/kg

Doses:

Male rats: 8.0, 4.0, 2.83, 2.0, 1.0 mL/kg bw (9384, 4692, 3320, 2346, 1173 mg/kg bw based on density of 1.173)
Female rats: 4.0, 2.0, 1.41, 1.0 mL/kg bw (4692, 2346, 1654, 1173 mg/kg bw based on density of 1.173)

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were weighed on days 0, 7 and 14. The frequency of observations for clinical signs of toxicity is not clarified in the study.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight and histopathology was performed to kidneys and bladders of animals treated with 1.0 to 4.0 mL/kg bw test substance.

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

2.55 mL/kg bw

Based on:

test mat.

Remarks on result:

other: equivalent to 2988 mg/kg bw

Effect levels 2

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

1.46 mL/kg bw

Based on:

test mat.

Remarks on result:

other: equivalent to 1713 mg/kg bw

Effect levels 3

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

2.01 mL/kg bw

Based on:

test mat.

Remarks on result:

other: equivalent to 2358 mg/kg bw

Mortality:

Death occurred between 1 to 6 days post-administration. the survivors recovered between 3 and 8 days from the 14-day study period. 5 out of 5 males treated with 8.0 or 4.0 mL/kg bw died, as well as 4 out of 5 males treated with 2.83 mL/kg bw. Male rats treated with lower doses survived the 14-day study period. 5 out of 5 females treated with 4.0 or 2.0 mL/kg bw died, as well as 2 out of 5 females treated with 1.41 mL/kg bw. The females treated with lower doses survived until the end of the study.

Clinical signs:

other: Signs of toxicity included sluggishness, lacrimation in two animals, salivation in one animal, prostration in two animals, red crust on the perinasal and periocular fur, red stain on the periurogenital fur and blood in the urine.

Gross pathology:

Necropsy of the animals that died during the study revealed pink to red lungs, discoloured livers, discoloured stomach or intestines, stomach distended with white material and/or gas, haemorrhaged stomachs, discoloured kidneys, one enlarged kidney, kidneys filled with white or brown material, bladders filled with red liquid and numerous instances of blood in the urine. Gross pathologic evaluation of survivors revealed one dark red liver, red to yellow intestines in one animal, and a trace amount of blood in the urine in one animal.

Other findings:

- Histopathology: The kidney lesions included hyaline droplet accumulation, tubular proteinosis and tubular epithelial cell degeneration, haemorrhage, tubular cell hyperplasia or hypertrophy, tubular basofilia, mineralization, pyelonephritis and microthrombi. In the bladder haemorrhage, hyperplasia, cellular debris, hyaline droplet accumulation and thrombi were observed. These lesions were notable at higher dose levels.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

In the acute oral toxicity study for tris[3-(trimethoxysilyl)propyl]-1,3,5-triazinane-2,4,6-trione, conducted according to a protocol similar to OECD 401, without information on compliance with GLP, the reported LD50 value for female rats was 1713 mg/kg bw.