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Description of key information

6 albino rabbits were tested for skin irritation with Acetoacet Amide according to a company guideline similar to OECD 404. Following this guideline 0.5 g of the test item were tested at the intact and abraded skin under occlusive coverage.

The exposure period was 4h. After removal of the patch the remnant test item was removed with appropriate solvent. The observation period was 48 hours after initial application.

None of the animals showed any signs of skin irritation or corrosion at any time.

Acetessigamidlösung ca. 30 %ig was tested for eye irritating proprties according to OECD 405. Following this protocol the left eyes of three rabbits were treated with 0.1 ml of 30 % aequous acetoacetamid solution.

The untreated right eyes served as control. 24 hours after instillation the treated eyes were washed with physiological saline (37°C). The examination of the eyes was performed 1, 24, 48 and 72 hours after application.

No signs of irritation were observed at any time.

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:
1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
Study conducted prior to GLP and OECD guideline implementation.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
DOT (Transport-Classification) Guideline
Deviations:
not specified
GLP compliance:
no
Remarks:
Study conducted prior to GLP and OECD guideline implementation.
Specific details on test material used for the study:
not available
Species:
rabbit
Strain:
not specified
Details on test animals or test system and environmental conditions:
albino rabbits
Type of coverage:
occlusive
Preparation of test site:
abraded
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
4 hours
Observation period:
48 hours after initial application
Number of animals:
6
Details on study design:
The intact and abraded skin of 6 albino rabbits was employed for this study. The hair was clipped from the backs with the aid of angora clippers. Four areas of the back, placed approximately ten centimeters apart, were designated for the patches. Areas 2 and 3 were abraded by making four epidermal incisions (two perpendicular to two others in the area of the patch). The patches consisted of 1.5 inch x 1.5 inch 12 ply gauze squares. The patches were secured to the area by thin bands of adhesive tape. The material to be tested (0.5 grams) was introduced beneath the patch. The entire trunks of the animlas were then wrapped in claear plastic trunk bands. The trunk bands help to hold the patches in position and retard evaporation of volatile substances during the four hours exposure period. Upon removal of the patches the resulting reactions were evaluated on basis of weighted scores.
Following this initial reading, all test sites were washed with appropriate solvent to prevent further exposure. Readings were again made at 24 and 48 hours after the iniitial application. Each test substance is evaluated on a total of site (6 abraded and 6 intact)
Irritation parameter:
erythema score
Basis:
animal: 1-6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks:
no signs of irritation (erythema) at any time
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal: 1-6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks:
no signs of irritation (erythema) at any time
Remarks on result:
no indication of irritation
Other effects:
No other effects reported.
Interpretation of results:
GHS criteria not met
Conclusions:
Based on the findings, Acetoacet Amide is not irritating to the rabbit skin.
Executive summary:

6 albino rabbits were tested for skin irritation with Acetoacet Amide according to a company guideline similar to OECD 404. Following this guideline 0.5 g of the test item were tested at the intact and abraded skin under occlusive coverage.

The exposure period was 4h. After removal of the patch the remnant test item was removed with appropriate solvent. The observation period was 48 hours after initial application.

None of the animals showed any signs of skin irritation or corrosion at any time.

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:
30 Mai 1989 - 2 June 1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG, breeding colony and Madörin AG, Füllingsdorf, Schweiz
- Age at study initiation: about 3 - 5 months
- Weight at study initiation: 2,6 - 3,3 kg
- Housing: in air conditioned rooms in single cages
- Diet: Altromin 2123 Haltungsdiät - Kaninchen, ad libitum. 15 grams hay per day
- Water : deionized and chlorinated water from automatic suspensors, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +- 3
- Humidity (%): 50 +- 20
- Photoperiod 12 hrs dark / 12 hrs light
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0,1 ml of the 30% aequous acetoacetamide-solution
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE:
Washing with physiological saline (37 °C) 24 hours after application of the test item and before each investigation

SCORING SYSTEM:
Cornea: 0 - 4
Iris: 0 - 2
Conjunctivae: 0 - 3
Chemosis: 0 - 4
Irritation parameter:
cornea opacity score
Basis:
other: animal # 100, 182 and 543
Remarks:
each
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
other: animal # 100, 182 and 543
Remarks:
each
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
other: animal # 100, 182 and 543
Remarks:
each
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
other: animal # 100, 182 and 543
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Other effects:
No other effects reported
Interpretation of results:
GHS criteria not met
Conclusions:
Based on the findings, Acetessigamidlösung (ca. 30 %ig) is not irritating to the rabbit eye.
Executive summary:

Acetessigamidlösung ca. 30 %ig was tested for eye irritating proprties according to OECD 405. Following this protocol the left eyes of three rabbits were treated with 0.1 ml of 30 % aequous acetoacetamid solution.

The untreated right eyes served as control. 24 hours after instillation the treated eyes were washed with physiological saline (37°C). The examination of the eyes was performed 1, 24, 48 and 72 hours after application.

No signs of irritation were observed at any time.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

Based on the irritation/corrosion data available, the substance is not classified as irritating and does not require labelling according to Regulation 1272/2008/EEC (CLP).

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