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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:
14.07.1987 to 17.07.1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Trimethoxyoctylsilane
EC Number:
221-338-7
EC Name:
Trimethoxyoctylsilane
Cas Number:
3069-40-7
Molecular formula:
C11H26O3Si
IUPAC Name:
trimethoxyoctylsilane
Test material form:
liquid

Test animals / tissue source

Species:
rabbit
Strain:
other: white Russian (albino)
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: ASTA Pharma AG, D-4800 Bielefeld 14
- Age at study initiation: 5-6 months
- Weight at study initiation: 2.4 to 2.6 kg
- Housing: Individually in stainless steel cages
- Diet (e.g. ad libitum): Not stated, but assumed to be ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: At least one day

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ±2
- Humidity (%): 55 ±15
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 14.07.1987 to 17.07.1987

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 (1. 24. 48, 72 hours)
Number of animals or in vitro replicates:
Three (one male, two females)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No

SCORING SYSTEM: Draize scale

TOOL USED TO ASSESS SCORE: Cliptrix pencil light

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: Irritation index
Basis:
mean
Time point:
other: 1, 24, 48 and 72 hours
Score:
4
Max. score:
80
Reversibility:
fully reversible
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:
2
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
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
Irritant / corrosive response data:
Cornea and iris did not show any findings. The conjunctiva reacted with hyperemia (grade 1) in one animal and in two animals diffuse crimson or beefy discolouration (grade 2 or 3) was observed. In addition, slight swelling (grade 1) or swelling with partial eversion of lids (grade 2) occurred. Swelling had completely disappeared at 24 hours and redness 48 or 96 hours after substance treatment. Discharge with moistening of considerable parts around the eye, was recorded in two animals only at observation time of one hour.
Other effects:
There were no systemic effects, and the general condition of the animals was undisturbed.

Any other information on results incl. tables

Effect  Hours after exposure      Animal irritation scores
  1 2 3
  Corneal opacity 1  0  0  0 
  24  0  0  0 
  48  0  0  0 
  72 0  0  0 
  Iritis 1  0  0  0 
  24  0  0  0 
  48  0  0  0 
  72 0 0 0
 Conjunctival redness 1  1  2  3
  24  1  1  2
  48  0  0 2
  72  0  0  0
 Conjunctival chemosis  1  1  2  2
   24  0  0  0
   48  0  0  0
   72  0  0  0
 Conjunctival discharge  1  0  3  3
   24  0  0  0
   48  0  0  0
   72  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 Test Guideline 405 but not in compliance with GLP (reliability score 2) trimethoxyoctylsilane was not irritating to the eyes of rabbits. There were no systemic effects.