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Diss Factsheets

Toxicological information

Toxicity to reproduction

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Administrative data

toxicity to reproduction
other: Effects on reproductive organs
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Publication in a recognized journal.
Reason / purpose for cross-reference:
reference to same study

Data source

Reference Type:

Materials and methods

Test guideline
no guideline followed
Principles of method if other than guideline:
Comparison of the known neurotoxicity and the effects on testis for acrylamide and possible effects for 13 related compounds.
GLP compliance:
not specified
Limit test:

Test material

Constituent 1
Reference substance name:
diacetone acrylamide
diacetone acrylamide
Details on test material:
Supplier: Tokyo Kasei Co

Test animals

other: ddY
Details on test animals or test system and environmental conditions:
- Age at study initiation: 5-6 weeks- Weight at study initiation: 29 +- 2.2 g- Housing: 5-7 per cage- Diet: ad libitum- Water: ad libitum

Administration / exposure

Route of administration:
oral: gavage
physiological saline
Analytical verification of doses or concentrations:
Duration of treatment / exposure:
8 - 10 weeks
Frequency of treatment:
twice weekly
Doses / concentrations
Doses / Concentrations:Doses ranging from 1/2 to 1/5 of the LD50. The LD50 = 7.7. mmol/kg. Doses therefore ranging from 261 to 651 mg/kg bw.Basis:
No. of animals per sex per dose:
5-7 animals per dose.
Control animals:
yes, concurrent vehicle
Details on study design:
To examine the effect of metabolic activation, sodium phenobarbital (PB), which was prepared from phenobarbital before use, was given intraperitoneally at 50 mg/kg for five successive days per week, from one week before, up until the last week of treatment with the test compounds


Postmortem examinations (offspring):
Histopathological study of the testis and examination of blood: After treatment with the test compounds for 8-10 weeks, mice were killed under ether anesthesia for histology and blood examination. The testis was weighed and fixed in 10% neutral formalin, processed, and embedded in paraffin. Ten-micron sections were stained with hematoxylin and eosin. Blood was taken from the right atrium with a heparinized syringe. Measurements of red and white blood cell counts, hemoglobin concentration, and hematocrit value, and differentiation of white blood cells, were conducted by routine methods.
Intergroup comparison was conducted by the Student's t-test.

Results and discussion

Results: P0 (first parental generation)

General toxicity (P0)

Clinical signs:
not examined
Body weight and weight changes:
no effects observed
Description (incidence and severity):
body weight
Food consumption and compound intake (if feeding study):
no effects observed
Description (incidence and severity):
body weight
Organ weight findings including organ / body weight ratios:
not examined
Other effects:
not examined

Reproductive function / performance (P0)

Reproductive function: sperm measures:
not examined
Reproductive performance:
not examined

Details on results (P0)

Effect on testis: Atrophy and reduced testis weight was noted in 5 compounds, but not in diacetone acrylamide. No histopathological lesions were reported for diacetone acrylamide.Effect of PB treatment: diacetone acrylamide was not tested.Blood study: Effects of test compounds on the blood were examined after the last treatment. Only one compound, N,N'-methylene-bis-acrylamide, produced marked effects on red and white blood cell counts, hemoglobin concentration and hematocrit value.

Results: F1 generation

General toxicity (F1)

Clinical signs:
not examined
Mortality / viability:
not examined
Body weight and weight changes:
not examined
Sexual maturation:
not examined
Organ weight findings including organ / body weight ratios:
not examined
Gross pathological findings:
not examined
Histopathological findings:
not examined

Overall reproductive toxicity

Reproductive effects observed:
not specified

Applicant's summary and conclusion

Diacetone acrylamide did not produce lesions of the testes in this type of experiment.
Executive summary:

Neurotoxicity of acrylamide and related compounds and their effects on the testis after repeated oral doses were studied in mice. Of fourteen analogues tested, five produced neuropathy; but diacetone acrylamide did not.

No effects on testis or blood were noted for diacetone acrylamide.