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Description of key information

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
1 520 mg/kg bw

Acute toxicity: via dermal route

Link to relevant study records
Reference
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.
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
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
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.
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.
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 000 mg/kg bw

Additional information

Acute oral toxicity:

Three weight of evidence results with rats are available, indicating the same level of toxicity: Wendtlandt 1991: LC50 >1000 mg/kg and <2000 mg/kg; Tanii 1991: LD50 = 1520; Vernon 1975: LD50 = 1770. The Wendtlandt report is the best described, but giving only a range of an LD50, the Tanii report is also of 1991 and gives the lowest concrete data, the Vernon report is older with a slightly higher LD50.

Acute inhalation toxicity:

The study is waived based on the unlikely human exposure.

Acute dermal toxicity:

The key study with rats and an LD50 >2000 mg/kg bw is supported by the study of Vernon 1975, reporting an LD50 for rabbits >10000 mg/kg bw.


Justification for selection of acute toxicity – oral endpoint
Three weight of evidence results with rats are available, indicating the same level of toxicity: Wendtlandt 1991: LC50 >1000 mg/kg and <2000 mg/kg; Tanii 1991: LD50 = 1520 mg/kg; Vernon 1975: LD50 = 1770 mg/kg. The Wendtlandt report is the best described, but giving only a range of an LD50, the Tanii report is also of 1991 and gives the lowest concrete value, the Vernon report is older with a slightly higher LD50. Therefore the Tanii study was selected.

Justification for selection of acute toxicity – inhalation endpoint
According to column 2 of Annex IX of REACH "Testing by the inhalation route is appropriate if exposure of humans via inhalation is likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size".
Diacetone acrylamide has a low vapour pressure of 0.109 Pa at 20 °C and a high particle size. 72.3 % by weight of the test substance have a particle size of >2000 µm. The mass median aerodynamic diameter of the fraction <2000 µm of diacetone acrylamide is 1245 µm. Exposure of humans is therefore not likely.
Experiments with the oral and dermal route of exposure are available.

Justification for selection of acute toxicity – dermal endpoint
More recent and sufficiently described study.

Justification for classification or non-classification

The acute oral toxicity of LD50 = 1520 mg/kg bw will require a classification in Acute Tox. 4, H302.