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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:
1995-01-06 to 1995-02-03
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report date:
1995

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
(3-chloropropyl)triethoxysilane
EC Number:
225-805-6
EC Name:
(3-chloropropyl)triethoxysilane
Cas Number:
5089-70-3
Molecular formula:
C9H21ClO3Si
IUPAC Name:
(3-chloropropyl)triethoxysilane

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS

- Source: Hazleton Research Products, Inc., Kalamazoo, Michigan
- Age at study initiation: ca. 4 months
- Weight at study initiation: 2661-2851g
- Housing: Individual hanging stainless steel wire mesh cages
- Diet: 125g/day, Certified Rabbit Chow #5322 (Purina Mills, Inc., Louis, Missouri)
- Water: ad libitum
- Acclimation period: 32 days

ENVIRONMENTAL CONDITIONS

- Temperature (°F): 67-69 (19.4-20.6 °C)
- Humidity (%): 54
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 30/12/1994 To: 03/02/1995

Test system

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

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



Duration of treatment / exposure:
Single instillation, not rinsed.
Observation period (in vivo):
Eye examinations were carried out at 1, 24, 48 and 72 hours after dosing.
Number of animals or in vitro replicates:
3 males
Details on study design:
REMOVAL OF TEST SUBSTANCE

- Washing (if done): not rinsed

SCORING SYSTEM: According to guideline.

TOOL USED TO ASSESS SCORE: hand-slit lamp, fluorescein

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
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
All three animals exhibited moderate redness and slight to very slight chemosis of the conjunctivae at the one-hour observation period. This conjunctival irritation cleared by the 24-hour observation period. The primary eye irritation score is 0.
Other effects:
No deaths or overt signs of toxicity were observed during the study.

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 

2/2/2 

2/1/1 

24 h

 0/0/0

 0/0/0

 0/0/0

 0/0/0

48 h

 0/0/0

 0/0/0

 0/0/0

 0/0/0

72 h

 0/0/0

 0/0/0

 0/0/0

 0/0/0

Average 24h, 48h, 72h

 0

Reversibility*

 -

Average time (unit) for reversion

 -

By 24 hours 

 By 24 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 an eye irritation study conducted according to OECD Test Guideline 405 and in compliance with GLP, (3-chloropropyl)triethoxysilane was not irritating to the rabbit eyes.