Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1976
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Mercapto subsituted silane ester Y-9261

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS

- Source: Carnegie-Mellon Research Institute
- Age at study initiation: 3-4 weeks
- Weight at study initiation: 90-120 g
- Diet: ad libitum
- Water: ad libitum


Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
16, 8 and 4 ml/kg
No. of animals per sex per dose:
3 (16 ml/kg), 5 (8 ml/kg), 5 (4 ml/kg)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days

- Necropsy of survivors performed: yes

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
6.17 mL/kg bw
Based on:
test mat.
95% CL:
ca. 4.57 - ca. 8.33
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
6 108 mg/kg bw
Remarks on result:
other: Based on specific gravity 0.99g/cm3
Mortality:
3/3 deaths in 16 ml/kg dose group, 4/5 deaths in 8 ml/kg group, 0/5 in 4 ml/kg group.
Clinical signs:
In the highest dose group (16 ml/kg) the animals were seen to be sluggish, deep breathing, with tremor-like muscular spasms and loss of coordination. The symptoms progressed to salivation and convulsions followed by the death of all three animals. Similar clinical signs were evident in the 8 ml/kg dose group, with the death of 4/5 animals. There were no deaths in the lowest dose group, but the animals appeared sluggish.
Body weight:
There were no remarkable changes in body weight.
Gross pathology:
In victims, petechial haemorrhages or congestion in the lungs; livers mottled; kidneys speckled and slightly congested; stomachs and intestines distended and liquid or gas-filled; intestines yellow. Nothing remarkable in survivors.
Other findings:
None reported.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
An acute oral LD50 value of 6.17 ml/kg (estimated to be equivalent to 6108 mg/kg bw) in rat is reported in a reliable study conducted according to a protocol equivalent to guideline.