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Toxicological information

Acute Toxicity: dermal

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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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
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

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 levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD0
Effect level:
>= 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was noted.
Clinical signs:
No clinical signs were noted.
Body weight:
Female nos. 8, 9 and 10 showed slightly loss of weight between day 1 and 8 of test. The body weight gain of the other animals was not affected throughout the entire study period.
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.