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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:
other: The study was well documented and meets generally accepted scientific principles, but was not conducted in compliance with GLP.

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:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male
Details on test animals 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:
None reported.
Body weight:
All survivors gained weight during the observation period.
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
Remarks:
Migrated information Criteria used for interpretation of results: EU
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 comarable 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.