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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:
supporting study
Study period:
2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2001

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Elevages Scientifique Dombes, France
- Age at study initiation: 10-11 weeks
- Weight at study initiation: 2.3-2.4 kg
- Housing: individually in stainless steel cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 'under laboratory conditions after health examination. Only animals without any visual signs of illness were used for the study.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 30-70
- Air changes (per hr): 10-14
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
Duration of treatment / exposure:
Single instillation.
Observation period (in vivo):
Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours, as well as 7, 10, 14, 17 and 21 days after test item application.
Number of animals or in vitro replicates:
1 male, 2 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 48 hours

SCORING SYSTEM: The ocular reaction was assessed according to the numerical scoring system listed in the EEC Commission Directive 92/69/EEC, July 31, 1992 (based on Draize scoring system).

TOOL USED TO ASSESS SCORE: diagnostic-lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Remarks on result:
positive indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 21 days
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 72 hours
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Remarks on result:
positive indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.67
Max. score:
2
Reversibility:
not fully reversible within: 21 days
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
Reversibility:
not fully reversible within: 21 days
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 10 days
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2.33
Max. score:
3
Reversibility:
not fully reversible within: 21 days
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 10 days
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2.33
Max. score:
3
Reversibility:
not fully reversible within: 17 days
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 10 days
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
fully reversible within: 17 days
Remarks on result:
positive indication of irritation
Irritant / corrosive response data:
A slight to marked opacity, affecting up to the whole area of the cornea at most readings, was evident in the male throughout the observation period and was still present on day 21. A slight corneal opacity, affecting approximately one quarter or less of the cornea, was observed in one female from the 72-hour to the 17-day reading. The other female showed a moderate to marked opacity, affecting up to the whole cornea at every reading, from 1 hour to 10 days after treatment. the cornea of this animal was opaque from 14 to 21 days after treatment. In addition, sub-corneal bleeding was observed in the male 17 days after treatment and in one female from 7 to 17 days after treatment.

The light reflex in the iris was delayed/reduced in the male at the 1 hour, 10 day, 14 day, 17 day and 21 day readings and was absent at the 72 hour and 7 day readings. The light reflex in one female was absent at all readings from 1 hour to 10 days after treatment. On test days 14 to 21 the iris of this animal was not discernible through the opacity. No abnormal findings were observed in the iris of the female at any reading.
Moderate to marked reddening of the conjunctivae was observed in the male throughout the observation period and moderate reddening was still evident on day 21. Slight reddedning was noted in one female from 1 hour to 7 days after treatment and slight to moderate reddening was evident in the other female from 1 hour to 14 days after treatment.
Moderate to marked swelling (with partial eversion of lids or with half closed to closed lids) was observed in the male from 1 hour to 17 days after treatment and slight swelling was still present on day 21. Slight swelling was noted in the one female from the 1 hour to the 7 day reading and slight to marked swelling was noted in the other female from the 1 hour to the 14 day reading.
The sclera could not be assessed in the male from 1 hour to 10 days after treatment or in one female from 1 to 72 hours after treatment due to swelling of the conjunctivae. Moderate reddening was observed in the male at the 14 day reading and slight to moderate reddening persisted up to termination on day 21. Slight to marked reddening of the sclera was evident in one female from 7 to 21 days after treatment. No abnormal findings were noted in the sclera of the other female at any reading.
At the 1 hour reading all animals were noted to have discharge with moistening of the lids and hair, and considerable area around the eye. Discharge, of various severity, continued to be observed in the male up to the day 17 reading, in one female up to the 24 hour reading and in the other female up to the 72 hour reading. No staining of the treated eyes by the test item was observed.
Other effects:
No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
In the in vivo eye irritation study with N-ethyl-3-trimethoxysilyl-2-methyl-propanamine, conducted according to OECD Test Guideline 405 and in compliance with GLP, the test substance was concluded to be causing irreversible eye damage rabbit eyes.