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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:
1994-11-29
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Guideline study reliable with restrictions - The stability was not stated. -According to the guideline, any effects other than ocular which were observed should be stated. It was not mentioned in this study if other than ocular effects were observed.

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)
Version / remarks:
, adopted 1987-02-24
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Calcium oxide
EC Number:
215-138-9
EC Name:
Calcium oxide
Cas Number:
1305-78-8
Molecular formula:
CaO
IUPAC Name:
Calcium oxide
Details on test material:
- Name of test material (as cited in study report): Calcium oxide (from Laboratoire Central Balthazar et Cotte)
- Physical state: White powder
- Analytical purity: 95.55 %
- Batch No.: 3314
- Storage condition of test material: At ambient temperature
- pH: The pH of the product, at 10 % concentration in distilled water, measured at the International Toxicology centre, was 9.
No further information on the test material was stated.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Elevage Cunicole de Val de Selle, 80160 Prouzel, France
- Weight at study initiation: 2782 g
- Housing: The animal was housed in polystyrene cage (35 X 55 X 32 cm or 48.2 X 58 X 36.5 cm) equipped with a trough and bottle.
- Diet (ad libitum): Food in form of granules "Rabbit maintenance, Reference 112 C" (UAR, 91360 Villemoisson-sur-Orge, France).
- Water (ad libitum): Drinking water, filtered through an F.G.Millipore membrane (0.22 micron) is distributed in bottles.
- Acclimation period: 5 days before the sart of the study

ENVIRONMENTAL CONDITIONS
- Temperature: 18 +/- 3 °C
- Humidity: 30 to 70 %
- Photoperiod (hrs dark / hrs light): 12/12
No further information on the test animal was stated.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): The lower eyelid was delicately opened, and a single dose of 100 mg of calcium oxide was introduced in the conjunctival cul-de-sac of the left eye. The lower and upper lids were maintained in contact for a second to prevent any loss of product.The right eye was administered no product and served as control.
No further information on amount/concentration applied was stated.

Observation period (in vivo):
The eyes were examined 1 hour after the administration of the product.
Number of animals or in vitro replicates:
One male rabbit
Details on study design:
REMOVAL OF TEST SUBSTANCE
The eyes were not rinsed after the administration of the product.

SCORING SYSTEM: Draize scoring system
All other damage observed is recorded.

TOOL USED TO ASSESS SCORE: If it was necessary the cornea was examined with an ultra-violet lamp. In the case of doubt as to the presence of corneal opacity, the eye is subjected to UV examination (the areas of corneal impairment are distinguished by a very clear fluorescence).
No further information on study design was stated.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 1 hour after administration
Score:
4
Max. score:
4
Remarks on result:
other: Given the seriousness of the eye lesions observed, the animal was put down for humanitarian reasons.
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: one hour after administration
Score:
2
Max. score:
2
Remarks on result:
other: Given the seriousness of the eye lesions observed, the animal was put down for humanitarian reasons.
Irritant / corrosive response data:
One hour after administration, very severe eye reactions were observed with a slight chemosis, a necrotised appearance of the conjunctiva, and total opacity of the cornea, showing a nacreous appearance. The iris was no longer visible. A purulent whitish substance was observed.
Given the seriousness of the eye lesions observed, the animal was put down for humane reasons, and the product was not tested on two other rabbits.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
Under the given experimental conditions the product calcium oxide is considered as an irritant to the eye in rabbits.
According to the Directive 67/548/EEC and subsequent regulations, the classification of the product, calcium oxide, should be "risk of serious damage to eyes".
According to the EC Regulation No. 1272/2008 and subsequent regulations, the test item is classified as Category 1.