Reaction mass of bis(trimethoxysilylpropyl)methylphosphonate and (trimethoxysilylpropyl)methylmethyl phosphate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes

Remarks:

GLP statement

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reaction Mass of bis(trimethoxysilylpropyl)methylphosphonate and (trimethoxysilylpropyl)methylmethylphosphonate

Molecular formula:

Constituent 1: C8H21O6PSi Constituent 2: C13H33O9PSi2

IUPAC Name:

Reaction Mass of bis(trimethoxysilylpropyl)methylphosphonate and (trimethoxysilylpropyl)methylmethylphosphonate

Test material form:

liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Langshaw Farms, Augusta, Michigan
- Age at study initiation: 'young' - no age specified
- Weight at study initiation: approximately 2.0 kg
- Fasting period before study: not specified
- Housing: individually in clean stainless steel cages
- Diet (e.g. ad libitum): Purina Rabbit Chow ad libitum
- Water (e.g. ad libitum): fresh water ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
Temperature, humidity and light controlled room. Specifics not stated.

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: dorsal body surface of the trunk
- % coverage: not stated
- Type of wrap if used: impervious plastic cuff held in place a cloth bandage taped to the hair

REMOVAL OF TEST SUBSTANCE
- Washing (if done): tap water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Concentration (if solution): 2.0 g/kg
- Constant volume or concentration used: yes

Duration of exposure:

24 hours

Doses:

2000 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: weighed 24 hours, 7 days and 14 days post test material application. Degree of skin irritation 30 minutes and 72 hours after washing
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths

Clinical signs:

other: None

Gross pathology:

No compound related gross pathological alterations

Other findings:

Very slight (Grade 1) erythema in 7/10 animals examined 30 minutes after 24 hour exposure. No visible signs of irritation in any animal 72 hours post-exposure.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In an acute dermal toxicity study, the test substance was tested in a limit test conducted according to a test guideline equivalent to OECD TG 402. Single dermal administration at 2000 mg/kg to five male and five female rabbits did not result in mortality. The acute dermal LD50 was therefore established to be greater than 2000 mg/kg in this study. Furthermore, the substance was judged to not meet the EU criteria for classification as a skin irritant.