Registration Dossier
Registration Dossier
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EC number: 200-540-9 | CAS number: 62-54-4
Eye irritation
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:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- 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 substance name:
- Calcium di(acetate)
- EC Number:
- 200-540-9
- EC Name:
- Calcium di(acetate)
- Cas Number:
- 62-54-4
- Molecular formula:
- C2H4O2.1/2Ca
- IUPAC Name:
- calcium diacetate
- Details on test material:
- - Name of test material (as cited in study report): Calciumacetat
Constituent 1
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.
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