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:
1995/01/06-1995/02/03
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to the appropriate OECD test guideline, and in compliance with GLP.

Data source

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

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
Details on test material:
- Name of test material (as cited in study report): Dow Corning 1-6376 Alkoxysilane

- Substance type: Alkoxy-Si

- Physical state: Clear liquid

- Storage condition of test material: Room temperature

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
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:
mean
Time point:
other: 24/48/72 hours
Score:
0
Max. score:
0
Reversibility:
other: no effects
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24/48/72 hours
Score:
0
Max. score:
0
Reversibility:
other: no effects
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24/48/72 hours
Score:
0
Max. score:
2
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24/48/72 hours
Score:
0
Max. score:
2
Reversibility:
fully reversible within: 24 hours
Irritant / corrosive response data:
All six 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:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material was deemed not irritating to the eye in a reliable study conducted according to an appropriate test protocol, and in compliance with GLP.