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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Organofunctional Silane Y-9616 (gamma-mercaptopropyltrimethoxysilane)
- Substance type: Organosilane
- Physical state: Liquid
- Stability under test conditions:
- Storage condition of test material: No data

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: No data
- Age at study initiation: No data
- Weight at study initiation: No data
- Housing: No data
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: No data


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

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml


Duration of treatment / exposure:
Four hours
Observation period:
14 days
Number of animals:
Six
Details on study design:
TEST SITE
- Area of exposure: No data
- % coverage: No data
- Type of wrap if used: occlusive


REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: four hours


SCORING SYSTEM: Draize

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: all
Max. score:
0
Remarks on result:
other: No erythema or oedema was observed in any animal at any time point.
Irritant / corrosive response data:
No erythema or oedema was observed in any animal at any time point.
Other effects:
No other effects reported.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In a detailed summary of a skin irritation study (reliability score 2; not to GLP), gamma-mercaptopropyltrimethoxysilane was not irritating to the skin of New Zealand white rabbits.
Executive summary:

Undiluted gamma-mercaptopropyltrimethoxysilane (0.5 ml) was applied to the intact (shaved) skin of six New Zealand white rabbits for four hours under an occlusive dressing. The dressings were then removed, the skin washed and the skin reactions observed for up to 14 days. None of the rabbits had any signs of skin irritation, and no other clinical signs of toxicity were observed. It was therefore concluded by the study authors that the test substance was not irritating to the skin.