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Administrative data

Description of key information

Skin irritation (OECD 404): not irritating 
Eye irritation (OECD 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:
16 Feb 1999 - 19 Feb 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)
Version / remarks:
adopted 1992
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Nederland, The Netherlands
- Age at study initiation: at least 6 weeks
- Weight at study initiation: less than 3.5 kg
- Housing: single housing
- Diet: standard laboratory rabbit diet (LKK-20, Hope Farms Woerden, The Netherlands), ad libitum. In addition hay (BMI, Helmond, The Netherlands) was provided once a week.
- Water: tap water diluted with decalcified water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 (Fluctuations were observed, but were not considered to be relevant)
- Humidity (%): 50 (Fluctuations were observed, but were not considered to be relevant)
- Air changes (per hr): 15
- Photoperiod: 12 hrs dark / 12 hrs light
Type of coverage:
semiocclusive
Preparation of test site:
other: clipping with electric clipper
Vehicle:
unchanged (no vehicle)
Controls:
other: adjacent areas of the untreated skin served as control
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 ml
- Concentration: undiluted test substance
Duration of treatment / exposure:
4 h
Observation period:
72 h (the test was probably completed after 72 h due to negative results at the 72 h reading)
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2 cm x 3 cm
- % coverage: no data
- Type of wrap if used: the test area was covered with a Metalline patch which was mounted on Micropore tape and was wrapped around the abdomen and secured with coban elastic bandage.

REMOVAL OF TEST SUBSTANCE
- Washing: Washing with water was performed.
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize scoring scheme

OBSERVATIONS:
The animals were observed twice daily for mortality/viability and at least once daily for toxicity. Body weights were recorded once before treatment. Skin reactions were recorded 1, 24, 48, and 72 h after treatment.
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: 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: not applicable
Irritant / corrosive response data:
After 1 hour an erythema (grade 1) was observed in all 3 animals, which was fully reversible within 24 hours.
Interpretation of results:
other: CLP/EU GHS criteria are not met, no classification required according to Regulation (EC) No 1272/2008
Conclusions:
A skin irritation study conducted in accordance with OECD 404 and GLP (reliability score 1), found ureidopropyltrialkoxysilane, mixed methoxy and ethoxy not to be irritating to the skin of rabbits. The report describes the material as non-irritant according to CLP criteria.
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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted in 1987
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River Nederlands, The Netherlands
- Age at study initiation: at least 6 weeks
- Weight at study initiation: less than 3.5 kg
- Housing: single housing
- Diet: Standard laboratory rabbit diet (LKK-20), Hope Farms, Woerden, The Netherlands (approximately 100 g per day). In addition, hay (BMI, Helmond, The Netherlands) was provided once a week.
- Water (e.g. ad libitum): Tap water diluted with decalcified water.
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 (Fluctuations were observed, but were not considered to be relevant)
- Humidity (%): 50 (Fluctuations were observed, but were not considered to be relevant)
- Air changes (per hr): 15
- Photoperiod: 12 hrs dark / 12 hrs light
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 ml
- Concentration: undiluted
Duration of treatment / exposure:
Single application without washing.
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM:
Draize scoring system
TOOL USED TO ASSESS SCORE:
24 hours after treatment fluorescein (2%) was instilled into both eyes of the animals to quantitatively assess the corneal epithelial damage.
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: 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: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.7
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.7
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.7
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
No effects on cornea or iris have been observed in any animal and at any time point. Conjunctival redness was observed in all 3 animals 1 hour after treatment up to 72 hours after treatment, and was fully reversibly within 7 days. The scores for redness were the same in all animals, being 2 at the time points 1, 24, and 48 hours. After 72 hours the scores decreased to 1 in all 3 animals. In 2 out of 3 animals a chemosis score of 3 was observed 1 hours after treatment, decreased to 1 at the time points 24 and 48 h, and was fully reversible within 72 hours. In the third animal the chemosis score was 3 after 1 hour, 2 after 24 hours, and 1 after 48 and 72 hours. It was fully reversible within 7 days.
Other effects:
Remnants of the test substance were observed on the outside of the eyelids.
Interpretation of results:
other: CLP/EU GHS criteria are not met, no classification required according to Regulation (EC) No 1272/2008
Conclusions:
In an eye irritation study according to OECD TG 405 and GLP (reliability score 1), only minor, transient eye irritation was observed following instillation of ureidopropyltrialkoxysilane, mixed methoxy and ethoxy esters in 3 rabbits. The scores of 0 for cornea and iris and the mean scores of 1.7 for conjunctivae and 0.9 for chemosis indicate that the test material would not be considered irritating to the eyes of rabbits.
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.

Skin irritation:

In a key skin irritation study, conducted in compliance with GLP and according to OECD TG 404, the test substance was not found to be corrosive or irritant (NOTOX, 1999). Treatment of 3 New Zealand White rabbits with 0.5 ml of the neat test substance for 4 h under semi-occlusive conditions provoked slight erythema (grade 1) but no edema reactions after 1 h in all 3 animals. The effects were fully reversible within 24 h. Therefore, mean values for erythema and edema over 24, 48, and 72 h was 0 for both endpoints. In conclusion, ureidopropyltrialkoxysilane, mixed methoxy and ethoxy esters is not irritant / corrosive under the conditions tested.

Eye irritation:

In an eye irritation study according to OECD TG 405 and GLP, only minor, transient eye irritation was observed following instillation of Ureidopropyltrialkoxysilane, mixed methoxy and ethoxy esters in 3 rabbits (NOTOX, 1999). The scores (mean over 24, 48, and 72 h) of 0 for cornea and iris and the mean scores of 1.7 for conjunctivae and 0.9 for chemosis indicate that the test material would not be considered irritating to the eyes of rabbits.

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.