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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
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 conducted according to a test protocol that is comparable to the appropriate OECD test guideline. It was not compliant with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
No necropsies and no weighing of animals.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: No data
- Age at study initiation: No data
- Weight at study initiation: 200 ± 2g
- Fasting period before study: Overnight
- Housing: Grid floor cages (segregated according to sex and dose)
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: No data


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ±2
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: No data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 12.6 ml/kg bw
Doses:
3.9, 5.0, 6.3, 10.0 and 12.6 ml/kg bw
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: Observed daily. Animals do not appear to have been weighed.
- Necropsy of survivors performed: no
Statistics:
LD50 and 95% confidence limits calculated using the method of Litchfield, J.T. and Wilcoxon, F. (1949) J. Pharm Exp Therap. 96. 99.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
7.5 mL/kg bw
95% CL:
>= 6 - <= 9.37
Mortality:
See Table 1.
Clinical signs:
Piloerection and lethargy within one hour of administration, followed by coma and death. All deaths occurred within 48 hours of administration and all survivors were generally asymptomatic after this time.
Body weight:
Not measured.
Gross pathology:
Not examined.
Other findings:
None reported.

Any other information on results incl. tables

Table 1 Summary of mortality data.

 Dose ml/kg       Cumulative deaths by day (/10)  Percentage mortality
   1  2  3  4  7  14  
 12.6  5  8  8  8  8  8  80
 10.0  7  7  7  7  7  7  70
 6.3  3  3  3  3  3  3  30
 5.0  3  3  3  3  3  30
 3.9  1  1  1  1  1  1  10

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In an acute oral toxicity study (reliability 2), that was conducted using a protocol similar to the now deleted OECD 401 (animals not weighed and no necropsies performed), but not to GLP, the LD50 for gamma-glycidyloxypropyltrimethoxysilane was 7.5 ml/kg bw (assuming a density of 1.07 g/cm3 this gives an LD50 of 8025 mg/kg bw).
Executive summary:

In an acute oral toxicity study (reliability 2) that was conducted using a protocol similar to the now deleted OECD 401 (animals were not weighed and no necropsies were performed), but not to GLP, the LD50 for gamma-glycidyloxypropyltrimethoxysilane was 7.5 ml/kg bw (assuming a density of 1.07g/cm3 this gives an LD50 of 8025 mg/kg bw).