N-(1,1-dimethyl-3-oxobutyl)acrylamide

Endpoint summary

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:

2004

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study with GLP.

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Species and strain: Rabbits, New Zealand White.Supplier: Charles River Deutschland GmbH, D-97633 Sulzfeld.Number and sex: 3 females.Body weights (at the start and at the termination of the study): 2.1-2.2 and 2.2-2.3 Hygiene: Optimal hygienic conditions.Room temperature: Average of 19.5 °C (continuous control and recording).Relative humidity: Average of 67.5 % (continuous control and recording).Light: Artificial light from 6 a.m. to 6 p.m.Cages: Individual caging in metal wire cages, Ehret GmbH, D-79312 Emmendingen, type KK 016R, 79 cm x 59 cm bottom area, 38 cm height.Feed: Altromin 2123 maintenance diet for rabbits, rich in crude fibre, ad libitum. Analysis of the feed for ingredients and contaminants is performed randomly by Altromin, D-32791 Lage, Germany.Hay-briquettes (supplied by SSNIFF, D-59494 Soest) are offered additionally as a dietary supplement.Water: Tap water from an automatic watering system, ad libitum.Environmental Enrichment: Aspen wood boards during acclimatisation and observation period. Exception: boards were withdrawn during the exposure.Acclimatisation: 5 daysIdentification: Individual labelling with felt-tipped pen on an ear pinna and cage labels.

Type of coverage:

semiocclusive

Preparation of test site:

other: clipped

Vehicle:

water

Controls:

not required

Amount / concentration applied:

Samples with approximately 0.5 g of the test substance were moistened with 1.0 mL deionised water and were placed on cellulose patches in a size of about 2.5 cm x 2.5 cm and were applied to the test sites.

Duration of treatment / exposure:

4 hours.

Observation period:

72 hours. Examination at 1, 24, 48 and 72 hours after the patch removal.

Number of animals:

3

Irritation parameter:

erythema score

Basis:

animal: each

Time point:

other: 1, 24, 48 and 72 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Irritation parameter:

edema score

Basis:

animal: each

Time point:

other: 1, 24, 48 and 72 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Other effects:

No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

All areas treated with the test substance and all control areas were normal before the application and at each observation time.

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Diacetone acrylamide is not irritating to skin.

Executive summary:

The possible irritation or corrosion by the test substance following a single application to the intact skin of rabbits was determined applying the EU-method. Results:

Test sites, exposed for 4 hours (three animals):

- Erythema/Eschars: Not affected.

- Oedema: Not affected.

Diacetone acrylamide 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:

2005

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study with GLP.

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Supplier: Charles River Deutschland GmbH, D-97633 Sulzfeld.Number and sex: 3 females.Body weights (at the start and at the termination of the study): 2.0-2.6 and 2.2-2.7 Hygiene: Optimal hygienic conditions.Room temperature: Average of 19.5 °C (continuous control and recording).Relative humidity: Average of 66.8 % (continuous control and recording).Light: Artificial light from 6 a.m. to 6 p.m.Cages: Individual caging in metal wire cages, Ehret GmbH, D-79312 Emmendingen, type KK 016R, 79 cm x 59 cm bottom area, 38 cm height.Feed: Altromin 2123 maintenance diet for rabbits, rich in crude fibre, ad libitum. Analysis of the feed for ingredients and contaminants is performed randomly by Altromin, D-32791 Lage, Germany.Hay-briquettes (supplied by SSNIFF, D-59494 Soest) are offered additionally as a dietary supplement.Water: Tap water from an automatic watering system, ad libitum.Environmental Enrichment: Wooden rest shelves.Acclimatisation: 5 days (1 animal) and 12 days (2 animals).Identification: Individual labelling with felt-tipped pen on an ear pinna and cage labels.

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

The weighed amounts of the individual doses were 55, 71 and 70 mg.

Duration of treatment / exposure:

The approximate equivalent of 0.1 mL of the test substance was administered per animal into the conjunctival sacs of the right eyes by gently pulling the lower lids away from the eyeballs for instillation. The eyes were held closed for about one second to prevent a loss of test substance.The left eyes remained untreated and served as a control.

Observation period (in vivo):

Both eyes of the animals were examined within 24 hours before the instillation and approximately 1, 24, 48 and 72 hours p.a. Animal 1 was also observed 6 d p.a.

Number of animals or in vitro replicates:

3

Details on study design:

Firstly, the test substance was given to one animal. As no evidence for a serious damage to the eye of this animal was found during the initial 72 hour observation period (no corrosive effect), the test substance was administered to the other two animals subsequently.

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: 1, 24, 48 and 72 h p.a. and 6 d p.a.

Score:

0 - 1

Max. score:

1

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: Score at 24 and 48 h p.a.: 1, 1/4 of the cornea was affected. Score at 0 and 72 h and at 6 d p.a.: 0

Irritation parameter:

cornea opacity score

Basis:

animal: 2 and 3

Time point:

other: 1, 24, 48 and 72 h p.a.

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Irritation parameter:

iris score

Basis:

animal: each

Time point:

other: 1, 24, 48 and 72 h p.a.

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 1, 24, 48 and 72 hours and 6 d p.a.

Score:

0 - 1

Max. score:

1

Reversibility:

fully reversible within: 6 d

Remarks on result:

other: Score at 1 to 72 h p.a.: 1; score at 6d p.a.; 0

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: 1, 24, 48 and 72 h p.a.

Score:

0 - 1

Max. score:

1

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: Score at 24 and 48 h p.a.: 1; Score at 1 and 72 h p.a.: 0

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

other: 1, 24, 48 and 72 h p.a.

Score:

0 - 1

Max. score:

1

Reversibility:

fully reversible within: 72 h p.a.

Remarks on result:

other: Score 1, 24 and 48 h p.a.: 1; Score at 72 h p.a.: 0

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: 1, 24, 48 and 72 h p.a. and 6 d p.a.

Score:

0 - 4

Max. score:

4

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: Score at 1 h: 4; Score at 24 h: 2; Score at 48 h: 1; Score at 72 h and 6 d p.a.: 0

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

other: 1, 24, 48 and 72 h p.a.

Score:

0 - 2

Max. score:

2

Reversibility:

fully reversible within: 72 h p.a.

Remarks on result:

other: Score at 1 h: 2; Score at 24 h: 2; Score at 48 h: 1; Score at 72 h: 0

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

other: 1, 24, 48 and 72 h p.a.

Score:

0 - 2

Max. score:

2

Reversibility:

fully reversible within: 48 h p.a.

Remarks on result:

other: Score at 1 h: 2; Score at 24 h: 1; Score at 48 h: 0; Score at 72 h: 0

Other effects:

No signs of systemic toxicity were observed in the animals during the test period and no mortality occurred.

The untreated eyes ("control eyes") were normal at each observation time. The eyes, treated with the test substance ("test eyes") were normal before the instillation.

The following mean scores were calculated for the examinations at 24, 48 and 72 h p.a.:

	Mean Scores for Animal No.:
	1	2	3
Corneae	0.7	0.0	0.0
Irises	0.0	0.0	0.0
Conjunctivae, redness	1.0	0.7	0.7
Conjunctivae, chemosis	1.0	1.0	0.3

Ocular lesions were reversible in all animals within 6 d p.a.

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Diacetone acrylamide is not irritating to skin.

Executive summary:

The possible irritation by the test substance following a single application to the intact eyes of rabbits was determined applying the EU-methods. Results:

- Corneae: Diffuse areas of opacity (score of "1", 25 % of the cornea affected) were observed in 2/3 animals from 1 h or 24 h onwards until a maximum of 48 h p.a.

- Irises: Not affected.

- Conjunctivae, redness: In all animals some injected blood vessels (score of "1") were observed from 1 h or 24 h onwards until a maximum of 72 h p.a.

- Conjunctivae, chemosis: Severe or obvious swelling (scores of "4" or "2"), decreasing afterwards, was seen in all animals from 1 h onwards until a maximum of 48 h p.a.

Diacetone acrylamide is not irritating to skin according to the EC classification scheme of Directive 2001/59/EC.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Justification for selection of skin irritation / corrosion endpoint:
Guideline study with GLP.

Justification for selection of eye irritation endpoint:
Guideline study with GLP.

Effects on eye irritation: slightly irritating

Justification for classification or non-classification

No indications were obtained to justify a classification.