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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:
1995/01/13-1995/03/23
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to the appropriate OECD 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
Details on test material:
- Name of test material (as cited in study report): 1-6376 Alkoxysilane

- Substance type: Alkoxy-Si (TRIALKOXY-Si)

- Physical state: Clear liquid

- Storage condition of test material: Room temperature.

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS

- Source: Hazleton Research Products, Inc., Kalamazoo, Michigan

- Age at study initiation: ca. 4 months

- Weight at study initiation: 2593-2918g males, 2561-2793g females

- Fasting period before study: not reported

- Housing: The animals were housed in individual hanging stainless steel wire mesh cages in an animal room.

- Diet: Up to 125g/day Certified Rabbit Chow ~5322, Purina Mills, Inc. St. Louis, Missouri

- Water: ad libitum

- Acclimation period: 25 days


ENVIRONMENTAL CONDITIONS

- Temperature (°F): 67-68 (19.4-20 °C)

- Humidity (%): 54

- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 30/12/1994 To: 07/02/1995

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE

- Area of exposure: dorsal skin

- % coverage: 15% of the body surface

- Type of wrap if used: The test site and torso was then wrapped with 8 ply gauze bandaging, occluded with plastic wrap and secured with 3" Dermiform tape.


REMOVAL OF TEST SUBSTANCE

- Washing (if done): The test site was washed with water and dried with disposable towels.

- Time after start of exposure: approximately 24 hours.


TEST MATERIAL

- Amount(s) applied (volume or weight with unit): 2.0163 ml/kg
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5M, 5F
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days

- Frequency of observations and weighing: The animals were observed approximately 1, 2 and 4 hours after test article administration on study day 1, then twice daily (morning and afternoon) for 13 additional days (once on the day of the necropsy). Individual body weights were obtained immediately prior to test article administration, on study day 8 and at study termination (day 15).

- Necropsy of survivors performed: yes

- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: A gross necropsy was performed on all animals euthanized (by intravenous sodium pentobarbital overdose) at study termination (day 15); no tissues were saved.
Statistics:
No statistical analysis was reported.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No deaths occurred during the 14-day study period.
Clinical signs:
Desquamation of the test site was noted in four animals. Additionally, a small red raised area on the test site was noted in a single animal. These signs are considered to be due to either the test article and/or treatment.
Body weight:
The small amount of weight loss noted in two animals on study day 8 is considered common for rabbits.
Gross pathology:
No macroscopic findings were noted at the time of necropsy. The antemortem observations were not confirmed at the time of necropsy.
Other findings:
- Potential target organs: None identified.

- Other observations: No sex specific differences reported.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
An acute dermal LD50 value of >2000 mg/kg bw was determined for rabbits in a reliable study, conducted according to an appropriate test guideline, and in compliance with GLP.