Registration Dossier

Administrative data

Description of key information

OECD TG 404: not irritating
OECD TG 405: not irritating

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
24-03-1980 to 27-03-1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
The restrictions was feeding conditions and analytical purity of the test substance was not provided in the study report.
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
feeding condition and analytical purity was not stated in the study report.
Qualifier:
according to
Guideline:
other: Federal Hazardous Substances Act as stated in the Code of Federal Regulations, 16 CFR 1500.42.
Deviations:
yes
Remarks:
feeding condition and analytical purity was not stated in the study report.
GLP compliance:
not specified
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Dutchland Laboratory Animals, Inc., Denver, Pennsylvania.
- Age at study initiation: Not stated.
- Weight at study initiation: Not stated.
- Housing: Individually in elevated metal cages.
- Diet : Commerical rabbit ration (Purina Lab Rabbit Chow©).
- Water : Water (via automated watering system) were available ad libitum.
- Acclimation period: Approximately for one-week period.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not stated.
- Humidity (%): Not stated.
- Air changes (per hr):Not stated.
- Photoperiod (hrs dark / hrs light):Not stated.

Type of coverage:
semiocclusive
Preparation of test site:
other: Abraded and shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: Untreated sites of the same animal served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
Duration of treatment / exposure:
24 h
Observation period:
Reading time points: 24 and 48 h. No further observation required.
Number of animals:
3 males and 3 females
Details on study design:
TEST SITE
- Area of exposure: Trunk. The skin at one site was abraded with minor incision and the skin of the other site remained intact.
- % coverage: Not stated
- Type of wrap if used: One-half-inch square gauze patch (two layers thick) which was secured with a non-absorbent binder composed of polyethylene tubing and Coban elastic bandage (Minnesota Minning and Manufacturing Company, St. Paul, Minnoesota).

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The exposure sites were wiped with gauze.
.
- Time after start of exposure: 24 h

SCORING SYSTEM: Draize scoring system
Irritation parameter:
erythema score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable.
Irritation parameter:
edema score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable.
Irritant / corrosive response data:
No erythema, oedema, ot other dermal effects were noted at any exposure site. The primary irritation score was zero.
Interpretation of results:
other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008
Conclusions:
In a reliable skin irritation study conducted according to OECD TG 404 but not in compliance with GLP, showed the test material was not a skin irritant.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
26-02-1980 to 04-03-1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
The restrictions was feeding conditions and analytical purity of the test substance was not provided in the study report.
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
feeding condition and analytical purity was not stated in the study report.
Qualifier:
according to
Guideline:
other: Federal Hazardous Substances Act as stated in the Code of Federal Regulations, 16 CFR 1500.42.
Deviations:
yes
Remarks:
feeding condition and analytical purity was not stated in the study report.
GLP compliance:
not specified
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Dutchland Laboratory Animals, Inc., Denver, Pennsylvania.
- Age at study initiation: Not stated
- Weight at study initiation: 2625 - 3000 g
- Housing: Individually in elevated metal cages.
- Diet : Commerical rabbit ration (Purina Lab Rabbit Chow©).
- Water : Water (via automated watering system) were available ad libitum.
- Acclimation period: Approximately for a three-week period.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not stated
- Humidity (%): Not stated
- Air changes (per hr):Not stated
- Photoperiod (hrs dark / hrs light):Not stated

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
Duration of treatment / exposure:
Group 1 - Single exposure, without washing
Group 2- Single exposure, with washing after 20 - 30 seconds.
Observation period (in vivo):
Reading time points: 24, 48, 72h and on days 4 and 7.
Number of animals or in vitro replicates:
Group 1- 3 males and 3 females
Group 2 -2 males and 1 female
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The rabbits in group 2 were given a washout 20 - 30 sec after instillation with lukewarm water for about 1 minute. The eyes of the animals in group 1 remained unwashed.
- Time after start of exposure: Approximately 20 - 30 seconds following administration of the dose.

SCORING SYSTEM: Draize scoring system.

TOOL USED TO ASSESS SCORE: fluorescein.
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
out of all 3 animals in group 1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable.
Irritation parameter:
iris score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility not applicable.
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
out all 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: reversibility not applicable.
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable.
Irritant / corrosive response data:
No corneal opacity, iritis, conjuctival redness, chemosis, or discharge was noted in the washed or unwashed treated eyes of any of the animals.
Other effects:
Three animals phonated and three aniamls excessively blinked and rubbed the treated eye upon instillation of the compound.
Interpretation of results:
other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008
Conclusions:
A reliable eye irritation study, conducted according to OECD TG 405 but not in compliance with GLP, showed the test material, phenyltrimethoxy silane, would not be considered an eye irritant.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Studies were chosen as key when the available study was of relevance and of sufficient quality for classification, labelling and for risk assessment.

 

A key skin irritation study, conducted according to OECD TG 404, found trimethoxphenylsilane was not irritating to rabbit skin. No erythema, oedema, or other dermal effects were noted at any exposure sites (Hazelton Laboratories, 1980a).

A key eye irritation study, conducted according to OECD TG 405, found trimethoxyphenylsilane was not irritating to the eyes of rabbit. No corneal opacity, iritis, or conjunctival redness, chemosis, or discharge was noted in the washed or unwashed treated eyes of any of the animals (Hazelton Laboratories, 1980b) .

Justification for classification or non-classification

The available data on skin and eye irritation of the registered substance do not meet the criteria for classification according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.