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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: dermal

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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:
study well documented, meets generally accepted scientific principles, acceptable for assessment

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

Constituent 1
Chemical structure
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
Remarks on result:
other: assuming a density of 1.07g/cm3 this gives an LD50 of 4248 mg/kg bw
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:
Category 5 based on GHS criteria
Remarks:
Not classified according to Regulation (EC) No. 1272/2008.
Conclusions:
In a pre-GLP, pre-guideline dermal irritation study (reliability score 2), conducted using a protocol comparable to OECD 402, the LD50 for glycidoxy propyltrimethoxysilane 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 glycidoxy propyltrimethoxysilane was 3.97 ml/kg bw (using a density of 1.07 g/cm3 this gives an LD50 of 4250 mg/kg bw) in rabbits.