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EC number: 604-102-1 | CAS number: 13893-53-3
- 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
Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- short-term repeated dose toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Meets generally accepted scientific standards, and is acceptable for assessment.
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Robust Summary for Aminoalkylnitrile Category
- Author:
- US EPA HPVIS
- Year:
- 2 006
- Bibliographic source:
- Doc ID 201-16274
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
Materials and methods
- Principles of method if other than guideline:
- A 28-day repeated dermal neurotoxicity study with 94.2% 2-amino-2,3-dimethylbutanenitrile was conducted to assess its potential to cause systemic toxicity and adverse effects on the nervous system. Test substance was administered dermally to rats (5/sex/group), at concentrations of 0, 3, 10, and 30 mg/kg (0, 3.578, 11.932, and 35.775 ml/kg) for 28 days (5 days/week, 6 hrs/day for 4 weeks). Test material was applied by gentle inunction
over the clipped area of unabraded skin. Dosages adjusted at 3-day intervals to accommodate body weight changes. The treated area was covered with an impervious patch. After 6 hrs, the patch was removed and the treated area thoroughly cleansed. Detailed observations, body
weights, and food consumption values were recorded at 3-day intervals. - GLP compliance:
- yes
Test material
- Reference substance name:
- 2-amino-2,3-dimethylbutanenitrile
- Cas Number:
- 13893-53-3
- Molecular formula:
- C6H12N2
- IUPAC Name:
- 2-amino-2,3-dimethylbutanenitrile
- Details on test material:
- Purity: 94.2%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Charles-River CD (Sprague-Dawley derived)
- Sex:
- male/female
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- Test substance was administered dermally to rats (5/sex/group), at concentrations of 0, 3, 10, and 30 mg/kg (0, 3.578, 11.932, and 35.775 µl/kg) for 28 days (5 days/week, 6 hrs/day for 4 weeks). Test material was applied by gentle inunction over the clipped area of unabraded skin. Dosages adjusted at 3-day intervals to accommodate body weight changes. The treated area was covered w/ an impervious patch. After 6 hrs, the patch was removed and the treated area thoroughly cleansed.
- Duration of treatment / exposure:
- 6 h a day/ 4 week exposure
- Frequency of treatment:
- 5 days a week
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 3, 10, and 30 mg/kg (0, 3.578, 11.932, and 35.775 µl/kg)
Basis:
- No. of animals per sex per dose:
- 5
- Control animals:
- yes
Examinations
- Observations and examinations performed and frequency:
- Detailed observations, body weights, and food consumption values were recorded at 3-day intervals.
- Sacrifice and pathology:
- All animals were perfused with 10% buffered neutral formalin solution prior to necropsy. The weights of the liver, kidney, heart, thyroid glands, brain, and gonads were recorded.
Results and discussion
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 3 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: for local effects (skin irritation)
- Dose descriptor:
- NOAEL
- Effect level:
- >= 30 mg/kg bw/day
- Sex:
- male/female
- Basis for effect level:
- other: for systemic effects with special focus on neurotoxicity
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
All rats survived the experimental period. There were no overt signs of toxicity observed at any treatment level; body weight gain, diet consumption, hematology and clinical chemistry values were comparable across all groups.
The weights of the liver, kidney, heart, thyroid glands, brain, and gonads were recorded. A statistically significant increase in absolute thyroid weights was observed in male rats at all treatment levels. Thyroid weights for females were somewhat increased though not significantly. Relative thyroid weights were also somewhat increased at all levels in both sexes with a significant increase in males at the 3 mg/kg level.
Subsequent histopathology failed to find any pathologic change that would account for this finding. No other significant organ weight changes were observed at any treatment level. No test article related gross or microscopic lesions were observed in the tissues samples from the adrenal gland, bone marrow, brain, eye and optic nerve, heart, liver, kidneys, lung, ovary, skeletal muscle, sciatic nerve, skin, spinal cord, testes, thyroid glands, and uterus. There were no overt signs of neurotoxicity (no lacrimation, no salivation, no tremors, no convulsions, no increased urination, no diarrhea, no piloerection) at any treatment level. Skin irritation, consisting of erythema, eschar formation, dry and/or flaky skin and small sores were observed at the application site in the 10 and 30 mg/kg groups. No significant irritation was seen in rats in the 3 mg/kg dose group.
The authors of this study therefore concluded that the NOEL is 3 mg/kg. As the intent of the repeated exposure dermal study is to assess systemic toxicity following dermal application of the test material, and as no evidence of systemic toxicity was seen at the high dose, one could conclude that 30 mg/kg did not produce systemic toxicity or neurotoxicity and should be considered a dermal NOEL.
Applicant's summary and conclusion
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.
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