Bis(pentane-2,4-dionato)calcium

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

November 18-21, 1991

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study was performed according to OECD guideline and GLP. No CoA included in the report.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Principles of method if other than guideline:

72 hour observation period instead of 14 days

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Bis(pentane-2,4-dionato)calcium

EC Number:

243-001-3

EC Name:

Bis(pentane-2,4-dionato)calcium

Cas Number:

19372-44-2

Molecular formula:

C10H14CaO4

IUPAC Name:

calcium bis[(2Z)-4-oxopent-2-en-2-olate]

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

Name: Ca-Acetylacetonate
Batch No.: 106002
Physical state: Powder
Purity: 98%

No CoA included in the report.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harald Schriever, Kaninchenfann, D-2740 Bremervorde, Neuendamm 88
- Age at study initiation: no data
- Weight at study initiation: no data
- Housing: individual housing (50 x 45 x 40 em, L x B x H) in a battery of cages, each equipped with a paper roll disposal system.
- Diet (e.g. ad libitum): ad libitum, Ssniff K pellets
- Water (e.g. ad libitum): ad libitum, drinking water as for human consumption
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%): 30-70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light):12/12

IN-LIFE DATES: November18-21,1991.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Remarks:

The test article was moistened sufficiently with aqua ad iniectabilia.

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

Duration of treatment / exposure:

4 hours

Observation period:

30-6 0min, 24, 48 and 72h after patch removal.

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: back
- % coverage: 6cm2
- Type of wrap if used: Each test area was covered with a semi-occlusive dressing consisting of KosmoplastR (Medilog), which was held in place by non-irritating tape ElastoplastR (BeiersdorfAG, Hamburg), and StiiIpaR (p.HartmannAG, Heidenheim/Brenz), which enveloped the whole of the animal's trunk.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the dressing was removed and any residual sample was carefully washed off with water or an appropriate solvent.
- Time after start of exposure: At the end of the 4-hexposure period.

SCORING SYSTEM:
Erythema and Eschar Formation
0 No erythema
1 Very slight erythema (barely perceptible)
2 Well-defined erythema
3 Moderate to severe erythema
4 Severe erythema (beetredness) to slight eschar formation (injuriesindepth)

Maximum possible = 4

Oedema Formation
0 No oedema
1 Very slight oedema (barely perceptible)
2 Slight oedema (edges of area well defined by definite raising)
3 Moderate oedema (raised approximately 1mm)
4 Severe oedema (raised more than 1mm and extending beyond area of exposure)

Maximumpossible = 4

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 30-60 min, 24, 48 and 72 h

Score:

0

Max. score:

4

Remarks on result:

other: No effects on skin were observed in this study

Irritant / corrosive response data:

No test article-dependent findings were observed.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

No test article-dependent findings were observed. The test substance is not irritating to skin.

Executive summary:

The potential toxicity of "Ca-Acetylacetonate" was assessed in an acute dermal irritation/corrosion test on 6 albino rabbits. The skin was exposed to the test substance for 4 h. Animals were examined for signs of erythema and oedema at 30-60 min, 24, 48 and 72 h post-exposure. No test article-dependent findings were observed. The test substance is not irritating to skin.