Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
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 402 (Acute Dermal Toxicity)
GLP compliance:
no
Test type:
fixed dose procedure
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:
rabbit
Strain:
other: albino
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS

- Source: Carnegie-Mellon Research Institute
- Age at study initiation: 3-5 months
- Diet: ad libitum
- Water: ad libitum


Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: the trunk
- Type of wrap if used: 'impervious sheeting'

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): maximum dose that can be retained is 16 to 20 ml/kg
Duration of exposure:
24 h
Doses:
16, 8, 4, 2, 1 ml/kg
No. of animals per sex per dose:
2 (16 ml/kg), 4 (8 ml/kg), 4 (4 ml/kg), 4 (2 ml/kg), 4 (1 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:
2.52 mL/kg bw
95% CL:
ca. 1 - ca. 6.33
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
2 494 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Based on specific gravity 0.99g/cm3
Mortality:
2/2 (16 ml/kg), 4/4 (8 ml/kg), 2/4 (4 ml/kg), 2/4 (2 ml/kg), 1/4 (1 ml/kg)
Clinical signs:
Erythema, ecchymosis, scabs, desquamation at application site.
Body weight:
Slight body weight losses were prevalent in test animals.
Gross pathology:
In victims, livers were paled and mottled, spleens dark, kidneys congested. Nothing remarkable in survivors.

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:
An acute dermal LD50 value of 2.52 ml/kg (estimated to be equivalent to 2494 mg/kg bw) in rat is reported in a reliable study conducted according to a protocol equivalent to guideline.