Registration Dossier
Registration Dossier
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EC number: 213-103-2 | CAS number: 924-42-5
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian germ cell study: cytogenicity / chromosome aberration
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well documented report of a guideline study conducted to GLP.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 995
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 478 (Genetic Toxicology: Rodent Dominant Lethal Test)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- rodent dominant lethal assay
Test material
- Reference substance name:
- N-(hydroxymethyl)acrylamide
- EC Number:
- 213-103-2
- EC Name:
- N-(hydroxymethyl)acrylamide
- Cas Number:
- 924-42-5
- Molecular formula:
- C4H7NO2
- IUPAC Name:
- N-(hydroxymethyl)acrylamide
- Details on test material:
- - Name of test material (as cited in study report): N-Hydroxymethyl acrylamide
- Substance type: organic
- Physical state: solid (powder)
- Analytical purity: 97-99% (based on MS, IR, UV and NMR)
- Impurities (identity and concentrations): not specified
- Composition of test material, percentage of components: 100%
- Isomers composition: not relevant
- Purity test date: not specified
- Lot/batch No.: not specified
- Expiration date of the lot/batch: not specified
- Stability under test conditions: stable
- Storage condition of test material: (animal room conditions
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- Swiss
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Raleigh, NC, USA
- Age at study initiation: 11 weeks
- Weight at study initiation: not specified
- Assigned to test groups randomly: no
- Fasting period before study: no
- Housing: group-housed during quarantine and the 1 week pre-mating period
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 2 weeks (quarantine)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 54
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 14:10
IN-LIFE DATES: not specified
Administration / exposure
- Route of administration:
- oral: drinking water
- Vehicle:
- Water (substance is totally water soluble and stable in water.
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: Each dose level was formulated by adding aliquots of the substance to carboys of de-ionised/filtered water with stirring. The stock solutions were stored at 4°C in the dark in glass or polycarbonate bottles and aliquotted into the drinking water bottles as necessary.
- Duration of treatment / exposure:
- Animals were exposed continually from weaning at postnatal day (pmd) 21 through mating at pmd 74 plus or minus 10.
- Frequency of treatment:
- Continuous
- Post exposure period:
- Not applicable
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0 ppm
Basis:
nominal in water
- Remarks:
- Doses / Concentrations:
60 ppm
Basis:
nominal in water
- Remarks:
- Doses / Concentrations:
180 ppm
Basis:
nominal in water
- Remarks:
- Doses / Concentrations:
360 ppm
Basis:
nominal in water
- No. of animals per sex per dose:
- 20, 20, 19 and 20 for the 0, 60, 180 and 360 ppm groups respectively.
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- None
Examinations
- Tissues and cell types examined:
- Uterus was assessed for resorption sites.
- Details of tissue and slide preparation:
- Not applicable
- Statistics:
- Statistical analyses were performed according to Heindel et, 1989 and Chapin et al, 1993. The male was considered the unit of analysis and the data from the 3 females were pooled.
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- positive
- Toxicity:
- yes
- Remarks:
- Neurotoxicity - Grip strength
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- not applicable
- Additional information on results:
- Early fetal resorption (2.98 vs 0.79 in the controls), total implantation loss (3.18 vs 1.06 in the controls) and live fetuses (10.5 vs 13.6 in the controls) were only significantly effected in the high dose group. Early fetal deaths were slightly impacted at the mid dose, even though this was also a neurotoxic dose.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): positive
N-methylolacrylamide induced dominant lethal mutations after almost 9 weeks of treatment in the domint lethal phase of a continuous breeding study.
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