[3-(2,3-epoxypropoxy)propyl]triethoxysilane

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

No data

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:

1962

Report date:

1962

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

[3-(2,3-epoxypropoxy)propyl]trimethoxysilane

EC Number:

219-784-2

EC Name:

[3-(2,3-epoxypropoxy)propyl]trimethoxysilane

Cas Number:

2530-83-8

Molecular formula:

C9H20O5Si

IUPAC Name:

Trimethoxy-[3-(oxiran-2-ylmethoxy)propyl]silane

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: No data
- Age at study initiation: 3-5 months
- Weight at study initiation: 2240 - 2730 grams
- Fasting period before study:
No further details available

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

No data

Duration of exposure:

24 hours

Doses:

2.5 and 5.0 ml/kg

No. of animals per sex per dose:

Four

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observed daily. Weighed at the end of the observation period
- Necropsy of survivors performed: no data
- Other examinations performed: gross necropsy

Statistics:

LD50 calculated using moving average method.

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

3.97 mL/kg bw

95% CL:

>= 2.93 - <= 5.37

Mortality:

Deaths occurred on the first and second days after application.

Clinical signs:

other: None reported.

Gross pathology:

Congested lungs, mottled livers with prominent acini, and off-colour kidneys with internal congestion.

Other findings:

Erythema and slight necrosis were observed.

Applicant's summary and conclusion

Interpretation of results:

not classified

Conclusions:

In a pre-GLP, pre-guideline dermal irritation study (reliability score 2), conducted using a protocol comparable to OECD 402, the LD50 for [3-(2,3-epoxypropoxy)propyl]trimethoxysilane was 3.97 ml/kg bw (using a density of 1.07 g/cm3 this gives an LD50 of 4250mg/kg bw) in rabbits.

Executive summary:

In a pre-GLP, pre-guideline dermal irritation study (reliability score 2), conducted using a protocol comparable to OECD 402, the LD50 for [3-(2,3-epoxypropoxy)propyl]trimethoxysilane was 3.97 ml/kg bw (using a density of 1.07 g/cm3 this gives an LD50 of 4250mg/kg bw) in rabbits.