Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 24.11.1981 to 23.12.1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The method used is equivalent to OECD 405 guideline. No GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
(No data on washing after exposure time)
Principles of method if other than guideline:
The Draize test is previous to OECD 405 Guideline.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Calciumacetat

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler; 6050 Offenbach/ Main.
- Weight at study initiation: Male median weight: 3.00 kg; Female median weight: 2.56 kg.
- Housing: Animals were housed individually in stainless steel cages, with an area of 40 cm x 51 cm.
- Diet (e.g. ad libitum): Ovator Solikanin 4 mm (Muskator Works 4000 Duesseldorf -1); Daily: 130 g per animal.
- Water (e.g. ad libitum): Daily: ca. 250 mL per animal.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-26 ºC
- Humidity (%): 30-70 %
- Photoperiod (hrs dark / hrs light): 12 hours light/ 12 hours dark

IN-LIFE DATES: From 24.11.1981 to 02.12.1981

Test system

Vehicle:
water
Controls:
other: Left eyes of treated animals served as negative controls.
Amount / concentration applied:
Volume: 0.1 mL (ca. 53 mg of test substance).
Test substance was applied on right eyes.
Observation period (in vivo):
Observation period: 8 days.
Observations at 1 h, 24 h, 48 h, 72 h, and 8 days after the test substance application.
Number of animals or in vitro replicates:
6 rabbits (4 males and 2 females) were used.
Details on study design:
SCORING SYSTEM: By Draize: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics. In Dermal Toxicity pp. 46-59. Austin, TEX: Association of Food and Drug Official of the United States, Texas, State Department of Health.
1.) Cornea
A) The degree of turbidity
0 No turbidity
1 Scattered or diffuse opacity iris still clearly visible
2 It is not quite transparent districts, details of iris Unclear
3 Opalescent areas, details of iris not discernible. Dimension of the pupil elusive
4 Opaque, iris invisible
B) Involvement of the cornea
0 No involvement
1 A quarter or less but not 0
2 It is larger than one quarter but less than half
3 It is greater than the Haälfte, but less than three quarters
4 Larger than three quarters until the entire cornea
2.) Iris
0 Normal
1 Abnormal wrinkling, congestion, swelling, vascular injection, iris reacts nor Lichteinrall
2 No reaction to light, haemorrhage, severe destruction
3.) Conjunctiva
A) Redness
0 Vessels normal
1 Hyperaemia
2 Diffuse rash, individual vessels can not be distinguished
3 Massive rash all sections
B) Swelling
0 No swelling
1 Slight swelling
2 Externally visible swelling of the lid is everted
3 Swelling that leads to half-closed lids
4 Swelling that leads to more than half - to fully-closed lids
C) Secretion
0 No abnormal secretion
1 Hypersecretion
2 Hypersecretion, which leads to moistening of the eyelids and surrounding hair
3 Hypersecretion, which considerable parts to moisten the eye

0 - 10: Non irritant
11 - 25: Slightly irritant
26 - 56: Moderately irritant
57 - 110: Severely irritant

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 h- 8 d
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 h
Score:
0.667
Max. score:
4
Remarks on result:
other: (Involvement)
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 48 h - 72 h
Score:
0.333
Max. score:
2
Remarks on result:
other: (Involvement)
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 h
Score:
2
Max. score:
2
Remarks on result:
other: (Redness)
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 48 h
Score:
1.167
Max. score:
2
Remarks on result:
other: (Redness)
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 72 h
Score:
0.833
Max. score:
2
Remarks on result:
other: (Redness)
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 h
Score:
1.333
Max. score:
2
Remarks on result:
other: (Swelling)
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 48 h
Score:
0.167
Max. score:
1
Remarks on result:
other: (Swelling)
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 72 h
Score:
0.333
Max. score:
2
Remarks on result:
other: (Swelling)
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 h
Score:
0.667
Max. score:
1
Remarks on result:
other: (Secretion)
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 48 h - 72 h
Score:
0.167
Max. score:
1
Remarks on result:
other: (Secretion)

Any other information on results incl. tables

Under test conditions, effects were fully reversible within 8 days.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under test conditions, Calcium Acetate was not irritating for the eyes of rabbits.
Executive summary:

The Acute eye irritation test was performed on Vienna White rabbits (males and females). Ca. 53 mg of Calcium Acetate was applied to the conjunctival sac of the right eye of 6 animals. The left eye served as the untreated control. Assessment of the irritant effect was made 1 h, 24 h, 48 h, 72 h, and 8 days after test substance application.

Under test conditions, Calcium Acetate was not irritating for the eyes of rabbits.