Registration Dossier

Administrative data

Description of key information

The substance 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.
A eye irritation/corrosion study was performed. In a single animal 0.1 g of test substance was instilled in the eye. The study was terminated after a hour as severe irritation was apparent. No further details. Since it is not possible to judge the reversibility of these effect and the scores are at the highest level the substance is classified corrosive to the eyes.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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.
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)
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.
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
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.
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
20 April 1999 - 4 June 1999
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was performed according to OECD guideline and GLP. The report is however very concise and does not contain full details on methods and results.
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
The report is however very concise and does not contain full details on methods and results.
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River Italia S.p.A.
- Age at study initiation: No data
- Weight at study initiation: No data
- Housing: No data
- Diet (e.g. ad libitum): No data
- Water (e.g. ad libitum): No data
- Acclimation period: No data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data

IN-LIFE DATES: No data
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye served as the control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g
Duration of treatment / exposure:
1 hour
Observation period (in vivo):
1 hour
Number of animals or in vitro replicates:
1
Details on study design:
REMOVAL OF TEST SUBSTANCE
No data

SCORING SYSTEM:
Draize

TOOL USED TO ASSESS SCORE:
No data
Irritation parameter:
conjunctivae score
Remarks:
discharge
Basis:
animal #1
Time point:
other: 1 hour
Score:
3
Max. score:
3
Reversibility:
other: the study was terminated after 1 hour
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 1 hour
Score:
4
Max. score:
4
Reversibility:
other: the study was terminated after 1 hour
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
other: 1 hour
Score:
3
Max. score:
3
Reversibility:
other: the study was terminated after 1 hour
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 1 hour
Score:
2
Max. score:
2
Reversibility:
other: the study was terminated after 1 hour
Irritation parameter:
cornea opacity score
Remarks:
opacity
Basis:
animal #1
Time point:
other: 1 hour
Score:
4
Max. score:
4
Reversibility:
other: the study was terminated after 1 hour
Irritation parameter:
cornea opacity score
Remarks:
involved area
Basis:
animal #1
Time point:
other: 1 hour
Score:
4
Max. score:
4
Reversibility:
other: the study was terminated after 1 hour
Irritant / corrosive response data:
The study was terminated after a hour as severe irritation was apparent. No further details.
Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The study was terminated after a hour as severe irritation was apparent. No further details. Since it is not possible to judge the reversibilty of these effect and the scores at all the highest level the substance is classified corrosive to the eyes.
Executive summary:

A eye irritation/corrosion study was performed according to OECD guidelines and GLP. In a single animal 0.1 g of test substance was instilled in the eye. The study was terminated after a hour as severe irritation was apparent. No further details. Since it is not possible to judge the reversibility of these effect and the scores are at the highest level the substance is classified corrosive to the eyes.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Effects on eye irritation: corrosive

Justification for classification or non-classification

Based on the available results the substance is not classified for skin irritation/corrosion and corrosive to the eyes, eye damage 1.