Registration Dossier
Registration Dossier
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EC number: 200-540-9 | CAS number: 62-54-4
Endpoint summary
Administrative data
Description of key information
Skin irritaton/corrosion: Key study: Experimental resuts: Calcium Acetate did not produce any irritation effect on the rabbit skin. Test method was similar to OECD guideline 404.
Eye irritation/corrosion: Key study: Experimental results: Test method was similar to OECD guideline 405. Under test conditions, Calcium Acetate was not irritating for the eyes of rabbits.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 10.11.1981 to 23.12.1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Test method was equivalent to OECD guideline 404. No GLP.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Gaukler; 6050 Offenbach/ Main.
- Weight at study initiation: Male median weight: 2.87 kg; Female median weight: 3.07 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 10.11.1981 to 19.11.1981 - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- Application form: 50% aqueous solution
- Duration of treatment / exposure:
- Exposure time: 4 hours
- Observation period:
- Observation period: 9 days.
Determinations at 30-60 minutes, 24 h, 48 h, and 9 days after test substance application.
At the end of the study, all animals were sacrificed and pathologically examined. - Number of animals:
- 3 animals were used (2 males and 1 female).
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of the time exposure, the test substance was removed with Lutrol, or with Lutrol and water (1:1).
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. - Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 24 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 24 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 48 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 48 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 48 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 9 d
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 9 d
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 9 d
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- other: redness
- Basis:
- animal #1
- Time point:
- other: 24 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- other: redness
- Basis:
- animal #2
- Time point:
- other: 24 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- other: redness
- Basis:
- animal #3
- Time point:
- other: 24 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- other: redness
- Basis:
- animal #1
- Time point:
- other: 48 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- other: redness
- Basis:
- animal #2
- Time point:
- other: 48 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- other: redness
- Basis:
- animal #3
- Time point:
- other: 48 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- other: redness
- Basis:
- animal #1
- Time point:
- other: 9 d
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- other: redness
- Basis:
- animal #2
- Time point:
- other: 9 d
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- other: redness
- Basis:
- animal #3
- Time point:
- other: 9 d
- Score:
- 0
- Max. score:
- 0
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Calcium Acetate did not produce any irritation effect on the rabbit skin.
- Executive summary:
The irritation and corrosive effects of Calcium Acetate acid was studied on Vienna White rabbits (two males and one female).
Animals were exposed for 4 hours to a 50 % aqueous solution and observed for 9 days.
Calcium Acetate did not produce any irritation effect on the rabbit skin.
Reference
Calcium Acetate did not produce any irritation effect on the rabbit skin.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- 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.
- 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
- 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 - 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
- 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)
- 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.
Reference
Under test conditions, effects were fully reversible within 8 days.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Skin irritaton/corrosion:
Key study: Experimental resuts: Test method was similar to OECD guideline 404.
The irritation and corrosive effects of Calcium Acetate acid was studied on Vienna White rabbits (two males and one female).
Animals were exposed for 4 hours to a 50 % aqueous solution and observed for 9 days.
Calcium Acetate did not produce any irritation effect on the rabbit skin.
Eye irritaton/corrosion:
Key study: Experimental resuts: Test method was similar to OECD guideline 405 .
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.
Justification for classification or non-classification
No irritant.
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