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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:
key study
Study period:
23 November 2004 to 5 January 2005
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report Date:
2005

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Elevage Scientifique des Dornbes, F-01400 Chatillon sur Chalaronne, France
- Age at study initiation: 14 weeks (males), 13-14 weeks (females)
- Weight at study initiation: No data
- Housing: Individually in stainless steel cages
- Diet: Pelleted standard Provimi Kliba 3418 rabbit maintenance diet, ad libitum
- Water: Community tap water, ad libitum
- Acclimation period: 5-6 days under laboratory conditions after health examination

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 23-Nov-2004 To: 30-Nov-2004

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: Untreated right eye served as reference control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): 100%
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
1, 24, 48 and 72 hours
Number of animals or in vitro replicates:
1 male, 2 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing : Not done

SCORING SYSTEM: Numercial scoring system listed in Commission Directive 2004/73/EC; classification according to Commission Directive 2001/59/EC and Kay JH and Calandra JC (1962). Interpretation of eye irritation tests. J. Soc. Cosmet Chem. 13, 281.

TOOL USED TO ASSESS SCORE: Varta Cliptrix diagnostic-lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
Calculated across 3 readings for all 3 animals
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
80
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: Very slight corneal opacity (1) affecting the whole area (4) in 1 animal at 1 hour
Irritation parameter:
iris score
Basis:
mean
Remarks:
Calculated across 3 reading for all 3 animals
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
10
Remarks on result:
other: No abnormal findings in the iris of any animal at any reading
Irritation parameter:
conjunctivae score
Remarks:
overall
Basis:
mean
Remarks:
Calculated across 3 readings for all 3 animals
Time point:
other: 24, 48 and 72 hours
Score:
0.67
Max. score:
20
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: Slight (1) to moderate (2) reddening of the conjunctivae in all 3 animals at 1 hour, slight reddening (1) persisted in 1 animal at 24 hours; slight (1) swelling (chemosis) in 2 animals at 1 hour
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
Calculated across 3 readings for all 3 animals
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: Slight swelling (chemosis) (1) of the conjunctivae 2 animals at 1 hour
Irritation parameter:
conjunctivae score
Remarks:
reddening
Basis:
animal #1
Remarks:
Mean score calculated across 3 readings
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: Slight reddening (1) of the conjunctiva at 1 hour
Irritation parameter:
conjunctivae score
Remarks:
reddening
Basis:
animal #2
Remarks:
Mean score calculated across 3 readings
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: Moderate reddening (2) of the conjunctiva at 1 hour
Irritation parameter:
conjunctivae score
Remarks:
reddening
Basis:
animal #3
Remarks:
Mean score calculated across 3 readings
Time point:
other: 24, 48 and 72 hours
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: Moderate reddening (2) of the conjunctiva at 1 hour, slight reddening (1) persisted to 24 hours.
Irritation parameter:
other: sclera
Basis:
other: Individual mean score calculated across 3 scoring times for each animal
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: Slight to moderate reddening of the sclera present in all animals at the 1-hour reading.
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:
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:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
3
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:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 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:
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
Irritant / corrosive response data:
No corrosion of the cornea at any of the reading times. Mild, early-onset and transient ocular changes (e.g. corneal opacity, reddening of the conjunctivae and sclerae and chemosis) were seen but these effects were reversible and were no longer evident 48 hours after treatment.
Other effects:
No clinical signs of systemic toxicity, no mortality, no staining of the eye, and body weights considered to be within normal range of variability.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In an eye irritation study in rabbits, conducted according to OECD Test Guideline 405 and in compliance with GLP, tri(isopropyl)silyl acrylate, tested at 100%, was not irritating.
Executive summary:

Tri(isopropyl)silyl acrylate was tested in an eye irritation test, conducted to OECD test guideline 405 and in compliance with GLP.

Undiluted test material (0.1ml) was applied to the left eyes of 3 rabbits, with the right eyes serving as controls. Eyes were examined 1, 24, 48 and 72 hours after application.

Some signs of irritation were seen at the 1- and 24-hour time points, but these had disappeared by the 48-hour time point.