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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
20 May - 04 Jun 2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report Date:
2015

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
(2012)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
(2008)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Version / remarks:
(1998)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Methyl-[3-(trimethoxysilyl)propyl]carbamate
- Physical state: clear colourless liquid
- Stability under test conditions: stable
- Storage condition of test material: at RT, protect from light, avoid humidity

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River France (L’Arbresle Cedex, France)
- Age at study initiation: 12 – 24 weeks
- Weight at study initiation: at least 1500 g
- Housing: animals were individually housed in labeled cages with perforated floors and shelters (Ebeco, Germany)
- Diet: pelleted diet for rabbits (Global Diet 2030, Harlan Teklad®, Mucedola, Milanese, Italy) approximately 100 grams per day; hay (TecniLab-BMI BV, Someren, The Netherlands) and wooden sticks (Swedish aspen wood, Bioservices, Uden, The Netherlands) were available during the study period.
- Water: (tap/filtered) water, ad libitum
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 24
- Humidity (%): 40 – 70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
single application without washing
Observation period (in vivo):
7 days
Reading time points: 1, 24, 48 and 72 h and day 7
Number of animals or in vitro replicates:
3 males
Details on study design:
SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.67
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.67
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
Instillation of 0.1 mL of the test substance into one eye of each of three rabbits resulted in effects on the cornea (grade 0.33) and iris (grade 0.33) in one animal and effects of the conjunctivae in all animals (grade 1.67, 1.67 and 0.67). The corneal injury consisted of opacity and epithelial damage. The corneal injury resolved within 7 days. Iridial irritation was observed at 24 hours and was resolved at 48 hours after instillation. The irritation of the conjunctivae consisted of redness, chemosis and discharge and completely resolved within 72 hours in one animal and within 7 days in the other two animals. There was no evidence of ocular corrosion. No signs of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Any other information on results incl. tables

Table 1: Individual eye irritation scores

Animal

Time after dosing

Cornea

 (0 – 4)

Iris

 (0 – 2)

Conjunctivae

(0 – 3)

Chemosis

(0 – 4)

 

 

1

1 hour

24 hours

48 hours

72 hours

7 days

mean 24+48+72 hours

0

0

1

0

0

0.33

0

1

0

0

0

0.33

2

2

2

1

0

1.67

2

1

1

0

0

0.67

 

 

2

1 hour

24 hours

48 hours

72 hours

7 days

mean 24+48+72 hours

0

0

0

0

0

0

0

0

0

0

0

0

2

2

2

1

0

1.67

2

1

0

0

0

0.33

 

3

1 hour

24 hours

48 hours

72 hours

mean 24+48+72 hours

0

0

0

0

0

0

0

0

0

0

2

1

1

0

0.67

1

0

0

0

0

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria are not met, no classification required according to Regulation (EC) No 1272/2008
Conclusions:
In an in vivo acute eye irritation/corrosion study in the rabbit according to OECD guideline 405 and in compliance with GLP no signs of systemic toxicity were observed in the animals during the test period and no mortality occurred. Therefore, the test material is considered to be classified as a non-irritant to eyes.