Calcium dihydroxide

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1994-12-22

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Guideline study reliable with restrictions - The purity and stability was not given in the test report. Minor deviation with no effect on the study results: - According to the guideline, any effects other than ocular which are 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:

yes

Remarks:

, see "rationale for reliability"

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Calcium dihydroxide

EC Number:

215-137-3

EC Name:

Calcium dihydroxide

Cas Number:

1305-62-0

Molecular formula:

CaH2O2

IUPAC Name:

calcium dihydroxide

Details on test material:

- Name of test material (as cited in study report): Calcium hydroxide (from Laboratoire Central Balthazar et Cotte)
- Physical state: White powder
- Batch No.: 3542
- Storage condition of test material: At ambient temperature
- pH: The pH of the product, at 10 % concnetration in distilled water, measured at the International Toxicology Centre, was about 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: 2708 g
- Housing: 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 the form of granules " Rabbit maintenance, Reference 112 C" (UAR, 91360 Villemoisson-sur-Orge, France).
- Water (ad libitum): Drinking water
- Acclimation period: 5 days before the start 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: The lower eyelid was delicately opened, and a single dose of 100 mg of the product as such was introduced in the conjuctival cul-de-sac of the left eye of the animal. 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 was recorded.

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

Results and discussion

In vivo

Results

Results 1

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, and the product was not tested on the other 2 rabbits.

Results 2

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: 1 hour after administration

Score:

3

Max. score:

3

Remarks on result:

other: Given the seriousness of the eye lesions observed, the animal was put down for humanitarian reasons, and the product was not tested on the other 2 rabbits.

Irritant / corrosive response data:

Very severe eye reactions were observed 1 hour after the treatment, with pronounced chemosis (score:3), necrotised appearance of the conjunctiva, whitish watering and total opacity of the cornea, showing nacreous appearance. The iris was no longer visible.
Given the seriousness of the eye lesions observed, the animal was put down for humanitarian reasons, and the product was not tested on the other 2 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 hydroxide, 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 hydroxide, should be irritant.
According to the EC Regulation No. 1272/2008 and subsequent regulations, the test item is classified as Category 1.