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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
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EC number: 229-222-8 | CAS number: 6440-58-0
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
![](https://poisoncentres.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- sub-chronic toxicity: dermal
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 411 (Subchronic Dermal Toxicity: 90-Day Study)
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- 5,5-dimethylhydantoin
- EC Number:
- 201-051-3
- EC Name:
- 5,5-dimethylhydantoin
- Cas Number:
- 77-71-4
- Molecular formula:
- C5H8N2O2
- IUPAC Name:
- 5,5-dimethylimidazolidine-2,4-dione
- Details on test material:
- The test material is the hydrolysis degradation product of DMDMH which was considered relevant for long term testing
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: CD
- Sex:
- male/female
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- water
- Details on exposure:
- TEST SITE
- Area of exposure: Entire application area in the high dose group and over proportionately smaller areas in the mid and low dose groups.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Rinsed with water
- Time after start of exposure: 6 hrs
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 3.0, 0.3, 1.0 and 3.0ml/kg/day
- Concentration (if solution): A constant concentration of 13% (w/w) in water was used for animals in DMH treatment groups. - Duration of treatment / exposure:
- 90 days
- Frequency of treatment:
- 6 hours/day, 5 days per week
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
39 mg/kg
Basis:
analytical per unit body weight
- Remarks:
- Doses / Concentrations:
130 mg/kg
Basis:
analytical per unit body weight
- Remarks:
- Doses / Concentrations:
390 mg/kg
Basis:
analytical per unit body weight
- No. of animals per sex per dose:
- 15/sex/group
- Control animals:
- yes, concurrent vehicle
Examinations
- Observations and examinations performed and frequency:
- DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Twice daily
BODY WEIGHT: Yes
- Time schedule for examinations: Weekly
FOOD CONSUMPTION: Yes
- Time schedule: Weekly
WATER CONSUMPTION: No
OPHTHALMOSCOPIC EXAMINATION: Yes
- Time schedule for examinations: Prior to first exposure and following sixty- third treatment
HAEMATOLOGY: Yes
- Time schedule for collection of blood: All animals at end of study
- Parameters: Haematocrit, haemoglobin, erythrocyte count, total and differential leukocyte count, platelet count, reticulocyte count, mean corpuscular volume (MCV), mean corpuscular haemoglobin (MCH),mean corpuscular haemoglobin concentration (MCHC)
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: All animals at end of study
- Parameters: sodium, potassium, chloride, calcium, phosphorus, glucose, cholesterol, urea nitrogen, total bilirubin, direct bilirubin, indirect bilirubin, creatinine, total protein, albumin, globulin, A/G ratio, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, gamma glutamyl transpeptidase
URINALYSIS: No - Sacrifice and pathology:
- Organ Weights: liver, kidneys, adrenals, testes, ovaries, spleen, brain, heart
Gross and histopathology: high dose group and controls organs: brain, spinal cord, pituitary, thyroid, parathyroid, thymic region, oesophagus, salivary glands, stomach, small and large intestines, liver, pancreas, kidneys, adrenals, spleen, heart, trachea, lungs, aorta, uterus, vagina, female mammary gland, prostate, testes, seminal vesicles, urinary bladder, lymph nodes sciatic nerve, femur, sternum (including marrow), eyes, exorbital lacrimal gland, thigh musculature, skin (treated and untreated)
Lungs, liver, kidneys, treated and untreated skin were examined from the low and mid-dose groups. In addition, submandibular lymph nodes were examined from all low and mid dose male rats - Statistics:
- Data for quantitative continuous variables were compared for the 3 treatment groups and control group by use of Levene’s test for equality of variances, analysis of variance (ANOVA), and t-tests. The t-tests were used when the F value from the ANOVA was significant. When Levene’s test indicated homogenous variances, and the ANOVA was significant, a pooled t-test was used for pairwise comparisons. When Levene’s test indicated heterogenous variances all groups were compared by an ANOVA for unequal variances followed, when necessary, by a separate variance t-test for pairwise comparisons. Nonparametric data were statistically evaluated using the Kruskal-Wallis test followed by the Mann-Whitney U test when appropriate. Incidence data were compared using Fishers exact test. For all statistical tests, the probability value of <0.05 (two-tailed) was used as the critical level of significance.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- One male from the control group was found dead on day 17 and one male from the low dose group was sacrificed moribund on day 39.
- Mortality:
- no mortality observed
- Description (incidence):
- One male from the control group was found dead on day 17 and one male from the low dose group was sacrificed moribund on day 39.
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Details on results:
- The death of the male rat in the low dose group was not considered to be treatment related due to a lack of dose-response relationship.
Effect levels
- Dose descriptor:
- NOEL
- Effect level:
- 390 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The NOEL for DMH is 390 mg/kg. The highest dose tested was limited by solubility.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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