Registration Dossier

Administrative data

Description of key information

No reliable skin or eye irritation data are available for the registered substance. Data are therefore read-across from the structural analogue 3-(trimethoxysilyl)propane-1-thiol (CAS 4420-74-0).

In a reliable skin irritation study not conducted to GLP,3-(trimethoxysilyl)propane-1-thiol was not irritating to the skin of New Zealand white rabbits (BRRC 1990).

In a reliable eye irritation study not conducted to GLP,3-(trimethoxysilyl)propane-1-thiol was not irritating to the eyes of New Zealand white rabbits (BRRC 1990).

See RAAF read-across justification in Section 13.

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system 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

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
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.
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No erythema or oedema was observed in any animal at any time point.
Other effects:
No other effects reported.
Interpretation of results:
GHS criteria not met
Conclusions:
In a detailed summary of a skin irritation study (reliability score 2; not in compliance with GLP), 3-(trimethoxysilyl)propanethiol was not irritating to the skin of New Zealand white rabbits.
Executive summary:

Undiluted 3 -(trimethoxysilyl)propanethiol (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.

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues 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

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1, 0.01 and 0.005 ml
Duration of treatment / exposure:
No data
Observation period (in vivo):
up to 21 days as necessary.
Number of animals or in vitro replicates:
Six per volume
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no


SCORING SYSTEM: Similar to OECD test guideline 405


TOOL USED TO ASSESS SCORE: fluorescein staining used to determine corneal injury
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No corneal injury or iritis was observed in any of the eyes. Within one hour minor transient conjunctival irritation (redness) was observed in 5/6 animals from the 0.1 ml group. All eyes were normal within 48 hours.
Other effects:
No other effects were reported.
Interpretation of results:
GHS criteria not met
Conclusions:
In a detailed summary of an eye irritation study (reliability score 2; not in compliance with GLP), 3-(trimethoxysilyl)propanethiol was not irritating to the eyes of New Zealand white rabbits.
Executive summary:

0.1, 0.01, and 0.005 ml of undiluted 3-(trimethoxysilyl)propanethiol was instilled into the lower conjunctival sac of one eye per rabbit (six rabbits per volume). The eyelids were held together for one second. The eyes were scored, by a scoring system similar to that recommended in OECD test guideline 405, at one, four and 24 hours, 2, 3 and 7 days after dosing. Additional readings were made, if necessary, at 14 and 21 days. Fluorescein (2%) staining was used to determine corneal injury before dosing and one day after instillation. No corneal injury or iritis was observed in any of the eyes. Within one hour minor transient conjunctival irritation (redness) was observed in 5/6 animals from the 0.1 ml group. All eyes were normal within 48 hours. Therefore overall the test substance was not irritating to eyes.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

No reliable skin or eye irritation data are available for the registered substance. Data are therefore read-across from the structural analogue 3-(trimethoxysilyl)propane-1-thiol (CAS 4420-74-0).

In a reliable skin irritation study not conducted to GLP, 3-(trimethoxysilyl)propane-1-thiol) was not irritating to the skin of New Zealand white rabbits (BRRC 1990). The undiluted test substance 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.

In a reliable eye irritation study not conducted to GLP), 3-(trimethoxysilyl)propane-1-thiol) was not irritating to the eyes of New Zealand white rabbits (BRRC 1990).

No corneal injury or iritis was observed in any of the eyes. Within one hour minor transient conjunctival irritation (redness) was observed in 5/6 animals from the highest dose volume group (0.1 ml). All eyes were normal within 48 hours. No other effects were reported.

Data to which reliability could not be assigned are available for the registered substance but insufficient study details were presented for skin and eye irritation (Carnegie-Mellon 1976). These studies are included as supporting data.

Justification for classification or non-classification

Based on the lack of effects in the available data read across from the structurally analogous 3-(trimethoxysilyl)propane-1-thiol (CAS 4420-74-0), no classification is required for skin or eye irritation according to Regulation (EC) No 1272/2008.