Registration Dossier

Administrative data

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.

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
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
no

Test material

Constituent 1
Chemical structure
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

Test animals

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

Test system

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.

Results and discussion

In vivo

Resultsopen allclose all
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

Any other information on results incl. tables

Calcium Acetate did not produce any irritation effect on the rabbit skin.

Applicant's summary and conclusion

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.