Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

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:
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. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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.