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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:
1987-05-26 until 1987-05-27
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and guideline study
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted 1981-05-12
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
of the Directive 84/449/EEC
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Disodium disilicate
EC Number:
237-623-4
EC Name:
Disodium disilicate
Cas Number:
13870-28-5
Molecular formula:
Na2Si2O5
IUPAC Name:
disodium disilicate
Details on test material:
- Name of test material (as cited in study report): Natriumschichtsilikat Na-SKS-6 kristallin
- Physical state and appearance: White powder
- Analytical purity: > 99%
- Storage condition of test material: Darkness at room temperature in a fume cupboard

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: HOECHST AG, Kastengrund
- Age of animals: About 3-5 months
- Animal weights: 2.8- 3.8 kg
- Housing: In fully air-conditioned rooms, separate cages (arranged in a battery)
- Diet (e.g. ad libitum): Altromin 2123 maintenance diet- rabbit (Altromin GmbH, Lage/Lippe), ad libitum and hay (approx. 15 g daily)
- Water (e.g. ad libitum): Water from automatic water dispensers, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20± 3°C
- Humidity (%): 50± 20%
- Photoperiod (hrs dark / hrs light): Lighting time: 12 hours daily

IN-LIFE DATES: From: 1987-05-26 To: 1987-05-27

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The untreated eyes (the right eyes) of the 3 rabbits served in each case as a control.
Amount / concentration applied:
100 mg disodium disilicate (delta-crystalline) was applied in a single dose.
Duration of treatment / exposure:
Not indicated
Observation period (in vivo):
1 hour and 24 hours after application
Number of animals or in vitro replicates:
3 rabbits
Details on study design:
SCORING SYSTEM: As instructed by the relevant guidelines.

TOOL USED TO ASSESS SCORE: Fluorescein (one drop of 0.01% fluorescein-sodium solution).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 24h
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 24h
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 24h
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 24h
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 1h
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 24h
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 1h
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 24h
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 1h
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 24h
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1h
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 24h
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24h
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 24h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24h
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 24h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24h
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 24h
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24h
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 24h
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 24h
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 24h
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 24h
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24h
Score:
3.33
Max. score:
4
Reversibility:
not fully reversible within: 24h
Irritant / corrosive response data:
Up to 24 hours after application the conjunctivae of the animals showed swellings: The lids were about half closed and a diffuse red beefy colour appeared. Additionally, clear-colourless or white-mocous discharge were noted. One hour after application the iris of all animals was reddened.
24 hours after application the cornea of the animals showed opacity areas, the iris was invisible. The conjunctivae and the nicating membrane were discoloured white. The conjunctival sac showed severe corrosions.
Other effects:
No other effects.

Any other information on results incl. tables

Due to the severe irritation findings, the animals were killled 24 hours after application.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Remarks:
Migrated information
Conclusions:
Under the study conditions, the test substance applied to the eyes of rabbits was found to be severely irritating to the eyes.
Executive summary:
In a primary eye irritation study (study no.: 94.0713) 100 mg of the test substance disodium disilicate (delta-crystalline) was instilled into the conjunctival sac of three New Zealand albino rabbits (weight: 2.8-3.8 kg, age: 3-5 months) while the untreated eye served in each animal as a control. The study was conducted according to the OECD 405 guideline and the EG guideline B.5. Up to 24 hours after application (the eyes were examined 1 hour and 24 hours after application), the state of the eyes of all animals reached the maximum scores in most of the examined parameters. In addition, a clear- colorless or white-mucous discharge was noted and the conjunctival sac showed severe corrosions. Due to the severe irritation findings the study was terminated after 24 hours and the animals were sacrificed. The test substance is therefore considered to be severely irritating to the eyes under the test conditions, in rabbits.

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