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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:
11-02-1994 to 22-03-1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study was conducted according to the appropriate OECD test guideline and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
other: Albino white
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Not reported.
- Age at study initiation: Young adult.
- Weight at study initiation: 2124 - 2430 g
- Housing: Individual suspended mesh-bottom cages.
- Diet: Purina® Certified Rodent Chow® provided ad libitum
- Water: Municipal water were provided ad libitum
- Acclimation period: The animals were acclimated to laboratory conditions for a minimum of five days prior to initiation of dosing.

ENVIRONMENTAL CONDITIONS
- Temperature: 68-71°F
- Humidity (%): 34-76
- Photoperiod (hrs dark / hrs light): 12/ 12.

IN-LIFE DATES: From: 22-04-1994 To: 06-05-1994

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: Clipped skin of the dorsal area of the trunk
- % coverage: 23%
- Type of wrap if used: Plastic wrap that was secured with Dermiform®.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The exposed site was wiped with disposable paper towels moistened with tepid tap water
- Time after start of exposure: 24 h

Duration of exposure:
24 h
Doses:
2000 mg/kg
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: Clinical observation and mortality were observed at approximately 1.0, 3.0 and 4.0 hours post-dose on Day 0 and twice daily thereafter for 14 days. Body weights were obtained and recorded on Days 0 (initiation), 7 and 14 (study termination). Also the application sites were examined for erythema, edema and other dermal findings beginning approximately 30-60 minutes after bandage removal and daily thereafter for thirteen days. The rabbit were shaved to facilitate dermal observations on Days 4, 7, 10 and 14
- Necropsy of survivors performed: yes. Upon termination of the study, the rabbits were euthanized by intravenous injection of sodium pentobarbital solution.
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, cranial, thoracic and abdominal cavities were examined for all animals.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no deaths during the study.
Clinical signs:
There were no clinical findings related to systemic toxicity. local effects were observed.
Body weight:
There were no remarkable changes or differences in body weights.
Gross pathology:
No treatment-related gross necropsy findings.
Other findings:
- Other observations:The test material induced severe erythema, moderate to severe edema, fissuring, eschar and exfoliation on all animals. In addition, six rabbits had corrosion and one site had blanching. Desquamation was present on all animals by day 5 and persisted throughout the remainder of the study. There were no other dermal findings. Severe erythema and slight to moderate edema persisted through study termination (Day 14) for four rabbits. Erythema decreased to slight and very slight for five and one animals, respectively, and edema decreased to slight or very slight for nine rabbits by study termination.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In an acute dermal toxicity study conducted according to OECD 402 and GLP, the LD50 of triethoxysilane was found to be greater than 2000 mg/kg when administered once for 24 hours to the shaved, intact skin of male and female albino rabbits.