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Administrative data

Description of key information

The key study for skin irritation, conducted according to OECD Test Guideline 404 and in compliance with GLP, found the test material not irritating to rabbit skin (WIL Research Laboratories, 1999c).

The key study for eye irritation, conducted according to OECD Test Guideline 405 and in compliance with GLP, found the test substance to be a mild irritant although the criteria for classification was not met (WIL Research Laboratories, 1999d).

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:
3 March 1999 - 20 May 1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Covance Research Products, Inc., Denver PA
- Age at study initiation: young adult
- Weight at study initiation: 3507 - 3642 g
- Housing:Individual, suspended in wire mesh cages.
- Diet: PMI Nutrition International, Inc. Certified Lab Diet 5322, circa 150 g/day
- Water: reverse osmosis treated municipal water, ad libitum
- Acclimation period: minimum 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.5 - 19.4 °C
- Humidity (%): 45.6-46.8 %
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL

- Amount(s) applied (volume or weight with unit): 0.5 mL

- Concentration: undiluted


Duration of treatment / exposure:
4 hour(s)
Observation period:
72 hours
Number of animals:
1 male and 2 females
Details on study design:
TEST SITE
- Area of exposure: dorsal skin
- Type of wrap if used: Cotton gauze patches, secured with a gauze binder and surgical tape.

REMOVAL OF TEST SUBSTANCE
- Washing: Excess test material was removed from treated skin areas following exposure.
- Time after start of exposure:4 hours

SCORING SYSTEM: Draize
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: No effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 4 days
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
Reversibility:
other: No effects observed
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
Reversibility:
other: No effects observed
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
Reversibility:
other: No effects observed
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
Reversibility:
other: No effects observed
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
See results section.
Other effects:
See results section.

No deaths or body weight changes were observed. Very slight erythema was noted for one animal at the 48- and 72-hour
observations. There was no edema or other dermal irritation noted. A primary irritation index score of 0.2 was
calculated from the results, consistent with a slight skin irritation potential in the rabbit.

Interpretation of results:
GHS criteria not met
Conclusions:
In a skin irritation toxicity study, conducted according to OECD test guideline 404 and in compliance with GLP, the test substance was found to be slightly irritating, as determined in a reliable study. The observed effects do not meet the criteria for classification as a skin irritant in the EU.
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:
3 March 1999 - 21 June 1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Covance research products, Inc., Denver, PA.
- Age at study initiation: young adult
- Weight at study initiation: 3898 to 4295 grams
- Housing: individual suspended wire mesh cages
- Diet: PMI Nutrition International, Inc. Certified Rabbit Lab Diet 5322, at ca. 150 g/day
- Water: reverse osmosis treated municipal water, ad libitum
- Acclimation period: minimum 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17.3-18.8 °C
- Humidity (%): 43.8-60.5 %
- Photoperiod: 12 hours dark / 12 hours light

Vehicle:
unchanged (no vehicle)
Controls:
other: Untreated eye.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL

- Concentration: undiluted
Duration of treatment / exposure:
Single instillation, not rinsed.
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: Not rinsed.

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: sodium fluorescein and UV light
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24/48/72h
Score:
0.7
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: No effects observed
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
Reversibility:
other: No effects observed
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
Reversibility:
other: No effects observed
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
Reversibility:
other: No effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: No effects observed
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
Reversibility:
other: No effects observed
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:
4
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:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: see 'Remark'
Remarks:
Minimal chemosis at 1 hour observation only
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: No effects observed
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
Reversibility:
other: No effects observed
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
There were no positive ocular findings noted during the study. All animals had minor conjunctival irritation that had completely subsided by day 3.

No death or significant body weight changes were observed. No corneal or iridal reactions were noted. Minor conjunctival reactions were noted in the treated eye of all animals. Conjunctival irritation subsided in 1 animal by day 2 and two animals by day 3. Redness was observed in two animals up to 48 hours, and in one animal up to 24 hours. Discharge was noted in one animal at 1 hour. Mean scores at the 1, 24, 48 and 72 hour time points were, 2.7, 2.0, 1.3 and 0.0, respectively. A maximum average score of 2.7 was calculated at the one-hour time point, indicating that  Tris(2-methoxyethoxy)vinylsilane was a mild irritant to the rabbit eye under the exposure conditions employed.

Interpretation of results:
GHS criteria not met
Conclusions:
In an eye irritation study, conducted according to OECD test guideline 405 and in compliance with GLP, the test substance was found to be a mild irritant, as determined in a reliable study. The observed effects do not meet the criteria for classification as an eye irritant in the EU.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The key study for skin irritation, conducted according to OECD Test Guideline 404 and in compliance with GLP, found the test material not irritating to rabbit skin when 0.5 mL of the test substance was applied to the dorsal skin of 1 male and 2 female rabbits. The test substance was applied for 4 hours and observed in total for 72 hours. No deaths occurred and no body weight changes were observed. Very slight erythema was noted for one animal at the 48 and 72 hours observations. No oedema or other dermal irritation was noted (WIL Research Laboratories, 1999c).

In a supporting in vivo skin irritation study, conducted in a similar manner to OECD Test Guideline 404 but pre-GLP, the test substance was not found to be irritating (Consultox Laboratories, 1976).

In a supporting skin irritation study, conducted in a similar manner to OECD Test Guideline 404 but pre-GLP, 0.5 mL of the test substance was applied to clipped intact skin under a gauze patch and was loosely covered with impervious sheeting. The test substance was found to be slightly irritating, however, the observed effects do not meet the criteria for classification as a skin irritant in the EU (Bushy Run Research Center, 1985).

The key study for eye irritation, conducted according to OECD Test Guideline 405 and in compliance with GLP, found the test material not irritating to rabbit eyes when 0.1 mL of the test substance was applied to untreated eyes. No deaths occurred and no significant body weight changes were observed. No corneal or iridial reactions were noted, however, minor conjunctival reactions were present in the eyes of all treated animals which subsided in all animals by day 3 (WIL Research Laboratories, 1999d).

In a supporting eye irritation study, not conducted according to a guideline or GLP, the test substance was found to be slightly irritating although the observed effects do not meet the criteria for classification as an eye irritant in the EU (Consultox Laboratories, 1976b).

Justification for classification or non-classification

Based on the available data, tris(2-methoxyethoxy)vinyylsilane does not require classification for irritation according to Regulation (EC) No 1272/2008.