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:
05.05.1992 to 21.05.1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

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:
liquid

Test animals / tissue source

Species:
rabbit
Strain:
other: white russian
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: ASTA Medica AG, D-4802 Halle-Künsebeck
- Age at study initiation: 8-10 months
- Weight at study initiation: Males: 2.58 kg; Females: 2.39 and 2.58 kg
- Housing: Individually in stainless steel cages
- Diet: Approx. 120 g/day/animal
- Water: Ad libitum
- Acclimation period: At least one day

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.5-20.0
- Humidity (%): 50-70
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 11.05.1992 To: 21.05.1992

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
Duration of treatment / exposure:
No rinsing
Observation period (in vivo):
Three days (including 1, 24, 48, 72 hours)
Number of animals or in vitro replicates:
Three
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: Cliptrix pencil light

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1, 24, 48 and 72 hours
Score:
2
Max. score:
110
Reversibility:
fully reversible
Remarks on result:
other: The eye irritation did not meet EU classification criteria.
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:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
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:
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:
Table 1. There were no changes to the cornea or iris. The conjunctiva of all three animals reacted with diffuse redness (grade 2). The finding had completely disappeared 48 hours after application. Slight swelling (grade 1) occurred in all three animals only one hour after application. In addition, discharge moistened lids and hair just adjacent to lids in one animal was observed one hour after application.
Other effects:
There were no systemic toxic effects in any of the animals.

Any other information on results incl. tables

Table 1 Summary of irritation scores

Reaction  Day/hours after exposure           Scores for each animal
     Animal 1  Animal 2  Animal 3
 Corneal opacity  1 h  0  0  0
   24 h  0  0  0
   48 h  0  0  0
   72 h  0  0  0
 Area of cornea involved  1 h  0  0  0
   24 h  0  0 0
   48 h  0  0  0
   72 h  0  0  0
 Iris  1 h  0  0  0
   24 h  0  0  0
   48 h  0  0  0
   72 h  0  0  0
 Conjunctival redness  1 h  2  2  2
  24 h   1  1  1
   48 h  0  0  0
   72 h  0  0  0
 Conjunctival Chemosis  1 h  1  1  1
   24 h  0  0  0
   48 h  0  0  0
   72 h  0  0  0
 Discharge  1 h  0  0  2
   24 h  0  0  0
   48 h  0  0  0
   72 h  0  0  0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In an eye irritation study conducted according to OECD 405 and in compliance with GLP (reliability score 1) triethoxy(octyl)silane was not irritating to the eyes of rabbits. There were no systemic effects.