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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:
March 1986
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
The study sponsor has indicated that the test material was a silicone material with ca. 5% mixture of triactoxyethylsilane + triacetoxymethylsilane.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Interfauna (UK) Ltd, Cambs, UK.
- Age at study initiation: adults
- Weight at study initiation: no data
- Housing: 1 per type III Drahtkäfige-high
- Diet: standard diet (SsniffK 4) ad libitum
- Water: ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 2
- Humidity (%): 45-65
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12h/ 12h

IN-LIFE DATES: no details

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye acted as the control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml

Duration of treatment / exposure:
24 h
Observation period (in vivo):
1h, 24h, 48h, 72h, 7 days
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): washed at 24h with physiological saline
- Time after start of exposure:

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE:
fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
other: 3 animals
Time point:
other: 24, 48, 72h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
other: 3 animals
Time point:
other: 24, 48, 72h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
other: 3 animals
Time point:
other: 24, 48, 72h
Score:
>= 0.7 - <= 1.7
Max. score:
3
Reversibility:
fully reversible
Remarks:
7 days
Irritation parameter:
chemosis score
Basis:
other: 3 animals
Time point:
other: 24, 48, 72h
Score:
0 - <= 0.7
Max. score:
4
Reversibility:
fully reversible
Remarks:
72h
Irritant / corrosive response data:
Conjunctival redness (grade 1 or 2) was reported in all animals at 24 and 48h and in one animal at 72h. Chemosis (grade 1) occurred in 1 animal at 24 and 48h. Conjunctival discharge occurred in 2 animals at 1h.

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 - redness

Conjunctivae-chemosis

Conjunctivae- discharge

Max. score: 4

Max. score: 2

Max. score: 3

Max. score: 4

Max. score 3

1 h

0/0/0

0/0/0

3/2/3

1/0/2

0/1/1

24 h

0/0/0

0/0/0

1/1/2

0/0/1

0/0/0

48 h

0/0/0

0/0/0

1/1/2

0/0/1

0/0/0

72 h

0/0/0

0/0/0

0/0/1

0/0/0

0/0/0

7 days

0/0/0

0/0/0

0/0/0

0/0/0

0/0/0

Average 24h, 48h, 72h

0/0/0

0/0/0

0.7/0.7/1.7

0/0/0.7

0/0/0

Reversibility*

n/a

n/a

c

c

c

Maximum for reversion

n/a

n/a

Day 7

72 h

24 h

* 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:
A generally reliable study, conducted according to OECD 405 but without GLP, reported mild, transient irritation to the eyes of rabbits that was entirely reversed after 7 days.