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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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 402 (Acute Dermal 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:

rabbit

Strain:

New Zealand White

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: 2000-3000 g
- 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

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: trunk
- % coverage: no data
- Type of wrap if used: gauze patch was wrapped around the trunk and bandaging tape was wrapped around the impervious sheeting

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data, but excess fluid was removed to diminish ingestion
- Time after start of exposure:

Duration of exposure:

24 hours

Doses:

16, 8 and 4 mL/kg bw

No. of animals per sex per dose:

5 male and 5 female treated with 16 mL/kg bw
1 male and 1 female treated with 8 or 4 mL/kg bw

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations for skin reactions were made at 1 hour, then on days 7 and 14 post-application. Body weights were recorded on days 0, 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs and body weight

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 16 mL/kg bw

Based on:

test mat.

Remarks on result:

other: equivalent to 19200 mg/kg bw

Mortality:

No deaths occurred during the 14-day observation period.

Clinical signs:

other: Diarrhoea was observed in one male treated with 16 mL/kg bw on day 14. No clinical signs of toxicity were observed in the rest of the test animals.

Gross pathology:

Mottled dark red lungs were observed in one male treated with 16 mL/kg bw. Haemorrhaged, liquid and gas-filled intestines were evident in another male treated with 16 mL/kg bw. Dark red lung was observed in one female treated with 8 mL/kg bw. No other macroscopic abnormalities were noted in the rest of the animals.

Other findings:

Erythema and oedema were noted in males and females treated with 16 mL/kg bw. Desquamation was evident in female group treated with 16 mL/kg on days 7 and 14.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In the acute dermal toxicity study for tris[3-(trimethoxysilyl)propyl]-1,3,5-triazinane-2,4,6-trione, conducted according to a protocol similar to OECD 404 without information about GLP compliance, the reported LD50 value is > 16.0 mL/kg bw in rabbits.