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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:
25 October - 11 November 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
performed under GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): crystalline calcium silicate hydrate (xonotlite - tobermorite)
- Physical state: solid
- Analytical purity: confidential information
- Lot/batch No.: confidential information
- Expiration date of the lot/batch: confidential information
- 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: Elevage de Gerome (Quafier Labaste - F40260 Linke)
- Age at study initiation: 12-13 weeks
- Weight at study initiation: 2.65-3.17 kg during test
- Housing: individual wire floored stainless steel cages of dimensions 61 cm x 46 cm x 36 cm
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C ± 3°C
- Humidity (%): from 30% to 70%
- Air changes (per hr): at least 10 cycles per hour
- Photoperiod (hrs dark / hrs light): circadian cycle (12 hrs day/12 hrs darkness)

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g
Duration of treatment / exposure:
At 1 hour after test item instillation, remaining test item was rinsed
Observation period (in vivo):
9 days (observations after 1, 24, 48, 72 hrs and 4, 8, and 9 days)
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): physiological rinse
- Time after start of exposure: 1 hour

SCORING SYSTEM: in accordance with OECD Guideline 405

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24, 48, and 72 hrs mean
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 72 hrs
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24, 48 and 72 hrs mean
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 9 days
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24, 48, and 72 hrs mean
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 6 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24, 48, and 72 hrs score
Score:
0.3
Max. score:
2
Reversibility:
fully reversible within: 48 hr
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24, 48, and 72 hrs meand
Score:
0.3
Max. score:
2
Reversibility:
fully reversible within: 48 hrs
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24, 48, and 72 hrs score
Score:
0.3
Max. score:
2
Reversibility:
fully reversible within: 48 hrs
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24, 48, and 72 hrs score
Score:
1.3
Max. score:
3
Reversibility:
fully reversible within: 9 days
Remarks on result:
other: redness
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24, 48, and 72 hrs score
Score:
2.3
Max. score:
3
Reversibility:
fully reversible within: 9 days
Remarks on result:
other: redness
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24, 48, and 72 hrs score
Score:
2.3
Max. score:
3
Reversibility:
fully reversible within: 6 days
Remarks on result:
other: redness
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24, 48, and 72 hrs score
Score:
1.7
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24, 48, and 72 hrs score
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 6 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24, 48, and 72 hrs score
Score:
1.7
Max. score:
4
Reversibility:
fully reversible within: 6 days
Irritant / corrosive response data:
- conjunctivae: moderate redness noted after 1 hr, totally reversible between day 6-9, moderate to important chemosis noted after 1 hr, totally reversible between day 6-8
- iris: congestion noted after 24 hr, totally reversible on day 2
- corneal: slight corneal opacity after 1 hr, totally reversible between 3-6
Other effects:
After 1 hr, lachrymation with moistening of the eyelids and large areas aroound the eye was observed in all animals. This effect was fully reversible within 24 hours (animal 2 and 3) or 48 hrs (animal 1).

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information according to CLP Criteria used for interpretation of results: EU
Conclusions:
Crystalline calcium silicate hydrate (xonotlite - tobermorite) induced corneal opacity and conjunctival redness. Based on the calculated means, the test item must according to Annex I of 1272/2008/EC (CLP/EU-GHS) be classified in category 2 "irritating to eyes".
Executive summary:

An in vivo eye irritation test was performed in accordance with OECD Guideline 405 to assess the eye irritation potential of crystalline calcium silicate hydrate (xonotlite - tobermorite). The test item induced corneal opacity and conjunctival redness, but all effects were fully reversible within 9 days. Based on the calculated means, the test item must according to Annex I of 1272/2008/EC (CLP/EU-GHS) be classified in category 2 "irritating to eyes".