Registration Dossier

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:
2000/10/02-2000/10/12
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid

Test animals / tissue source

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 adults

- Weight at study initiation: 2501 to 2936 g

- Housing: Individual suspended wire mesh cages. The animals were maintained by the animals husbandry staff of WIL Research laboratories, Inc. in accordance with standard operating procedures.

- Diet: PMI Nutrition International, Inc. Certified Rabbit LabDiet 5322 was offered at approximately 150 g per day.

- Water: Municipal water, ad libitum

- Acclimation period: minimum of 7 days


ENVIRONMENTAL CONDITIONS

- Temperature (°F): 67-69 (19.4-20.6 °C)

- Humidity (%): 40-61

- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: Untreated eye.
Amount / concentration applied:
TEST MATERIAL

- Amount(s) applied (volume or weight with unit):0.1ml

- Concentration (if solution): undiluted

Duration of treatment / exposure:
Single instillation, not rinsed.
Observation period (in vivo):
The eyes were examined for ocular reactions as approximately 24, 48 and 72 hours after dosing.
Number of animals or in vitro replicates:
3 females
Details on study design:
REMOVAL OF TEST SUBSTANCE

- Washing (if done): not rinsed

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: fluorescein and UV lamp

Results and discussion

In vivo

Resultsopen allclose all
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 #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 #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
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:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.66
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
Irritant / corrosive response data:
Minor conjunctival irritation (grade 1) was observed in the treated eye of all animals, which completely subsided by 72 hours. There were no corneal or iridial findings.
Other effects:
There were no deaths or test article - related body weight changes during the study period.

Any other information on results incl. tables

Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility

Cornea

Iris

Conjunctivae

Chemosis

Max. score: 4

Max. score: 2

Max. score: 3

Max. score: 4

60 min

0/0/0

0/0/0

       1/1/1

1/0/1 

24 h

0/0/0 

 0/0/0 

1/1/1 

0/0/0

48 h

0/0/0

0/0/0

1/0/1 

 0/0/0 

72 h

0/0/0

0/0/0

 0/0/0  

 0/0/0 

Average 24h, 48h, 72h

 0

 0

 0.55

 0

Reversibility*)

 -

-

c

Average time (unit) for reversion

 -

 By 72 hours

 -

 *) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In the eye irritation study, condicted according to OECD TG 405, and in compliance with GLP, the test substance, 3-trimethoxysilylpropyl methacrylate, was reported to be not irritating to eyes.