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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: A guideline study with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

diacetone acrylamide

IUPAC Name:

diacetone acrylamide

Details on test material:

Description: white solidBatch Number: T-49305Purity: 99.5 %Stability of test article: stableStability of test article dilution: stable for at least 2 hoursStorage Conditions: 20 °C

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS- Source: BRL, Biological Research Laboratories Ltd.; CH-4414 Füllinsdorf- Age at study initiation: males: 10 weeks, females: 12 weeks- Weight at study initiation: males: 243 - 246 g; females: 206 - 217 g- Housing: Individually- Diet (ad libitum): Pellet standard Kliba 343.- Water (ad libitum): Tap water- Acclimation period: 1 weekENVIRONMENTAL CONDITIONS- Temperature (°C): 22 +- 3- Humidity (%): 40-70- Air changes (per hr): 10-15- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Vehicle:

water

Details on dermal exposure:

The test article was placed into a glass beaker on a balance and the vehicle (bi-distilled water) was added. A weight/volume dilution was prepared using a homogenizer.Approximately 24 hours before treatment, the backs of the animals were shaved with an electric clipper, exposing an area of approximately 10 % of the total body surface.On test day 1 the test article was applied evenly an the skin with a syringe and covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and fixed with an elastic adhesive bandage.Application Volume: 4 ml at 2000 mg/kg bw.Twenty-four hours after the application, the dressing was removed. The treated skin was washed with lukewarm tap water, dried with disposable paper towels and the skin reaction was assessed according to the method of Noakes and Sandersan, 1969.

Duration of exposure:

24 h

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

5 males + 5 females

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days- Frequency of observations: Four times during test day 1, and daily during days 2 - 15.- Frequency of weighing: Days 1, 8 and 15.- Necropsy of survivors performed: yes.- Other examinations performed: clinical signs.

Statistics:

No.

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

male/female

Dose descriptor:

LD0

Effect level:

>= 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was noted.

Clinical signs:

other: No clinical signs were noted.

Gross pathology:

No macroscopical organ changes were observed.

Other findings:

None.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated informationCriteria used for interpretation of results: EU

Conclusions:

The LD50,dermal,rat of diacetone acrylamide is greater than 2000 mg/kg body weight.

Executive summary:

Diacetone acrylamide was applied to the skin of rats of both sexes for 24 hours at a single dose of 2000 mg/kg. No mortality, no local or clinical signs and no macroscopical organ changes were observed. The LD50,dermal,rat of diacetone acrylamide is greater than 2000 mg/kg body weight.