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EC number: 239-914-1 | CAS number: 15816-71-4
- 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
Toxicity to reproduction
Administrative data
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1998
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 998
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 421 (Reproduction / Developmental Toxicity Screening Test)
- Deviations:
- not specified
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Dicyclohexylamine
- EC Number:
- 202-980-7
- EC Name:
- Dicyclohexylamine
- Cas Number:
- 101-83-7
- Molecular formula:
- C12H23N
- Test material form:
- not specified
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- Males: 49 days
Females: from 14 days before mating to day 3 of lactation - Frequency of treatment:
- once daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 20 mg/kg bw/day (nominal)
- Dose / conc.:
- 40 mg/kg bw/day (nominal)
- Dose / conc.:
- 80 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 12
- Control animals:
- yes
Examinations
- Parental animals: Observations and examinations:
- clinical signs of toxicity, body weight, mortality, pathology of male organs, number of pairs mated, number of pairs copulated, number of pregnant females, days until copulation, copulation index (no. of pairs with successful copulation / no. of pairs mated) X 100 fertility index (no. of pregnant rats / no. of pairs with successful copulation) X 100duration of gestation, ---gestation index(no. of females with live pups / no. of pregnant females) X 100, ---implantation index (no. of implantations / no. of corpora lutea) X 100
- Oestrous cyclicity (parental animals):
- estrus cycle length
- Sperm parameters (parental animals):
- not specified
- Litter observations:
- live birth index (no. of live pups on day 0 / no. of pups born) X 100, ---delivery index (no of pups born / no. of implantations) X 100, ---sex ratio (no of males /no of females), ---viability index (no of live pups on day 4 / no. of live pups on day 0) X 100, body weight of pups on day 0 and day 4
- Postmortem examinations (parental animals):
ORGANS EXAMINED AT NECROPSY (reported organs): --Organ weight (absolute and relative): - male, right and left testes, right and left epididymides
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- unspecific signs of intoxication
- Dermal irritation (if dermal study):
- not examined
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- In the 80 mg/kg bw/day-group, 1 dam died on day 21 and another dam on day 22 of gestation.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Suppression of body weight gain in both sexes (male: treated rat versus control: 507 g versus 543 g) and low food consumption were observed.
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- no effects observed
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- effects observed, treatment-related
- Description (incidence and severity):
- 80 mg/kg:
Number of stillborn pups was significantly increased (55 versus 11 in controls) and the number of live born pups significantly decreased (72 versus 169 in controls) as well as live born index (58 % versus 94 % in controls), viability index reduced in pups (20.8 % versus 99 % in controls), pup weights on day 0 significantly (m/f: 6.1 g/5.5 g versus 7.3 g/7.0 g) and on day 4 slightly but not statistically significantly reduced (m/f: 9.0 g/8.6 g versus 11.8 g/11.1 g), poor maternal behavior and nursing observed in 7 dams.
Effect levels (P0)
open allclose all
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 40 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- mortality
- body weight and weight gain
- food consumption and compound intake
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 80 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: no effects
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- mortality observed, treatment-related
- Description (incidence and severity):
- Offsprings of the 80 mg/kg bw/day-dosed animals:number of stillborn pups significantly increased (55 versus 11 in controls),number of live born pups significantly decreased (72 versus 169 in controls) as well as live born index (58 % versus 94 % in controls), viability index reduced in pups of the 80 mg/kg bw/day group (20.8 % versus 99 % in controls) and pup weights on day 0 significantly (m/f: 6.1 g/5.5 g versus 7.3 g/7.0 g) and on day 4 slightly but not statistically
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Pup weights on day 0 significantly (m/f: 6.1 g/5.5 g versus 7.3 g/7.0 g) and on day 4 slightly but not statistically
significantly reduced (m/f: 9.0 g/8.6 g versus 11.8 g/11.1 g) - Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- 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
- Other effects:
- not specified
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- not examined
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- not examined
Effect levels (F1)
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 40 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
Target system / organ toxicity (F1)
- Key result
- Critical effects observed:
- not specified
Overall reproductive toxicity
- Key result
- Reproductive effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- In an OECD reproduction/developmental toxicity screening test (OECD TG 421) in rats dicyclohexylamine revealed effects on reproduction only in females at the highest oral dose tested (80 mg/kg bw/day) including slightly reduced gestation index, increase in stillborn pups and decrease in live born pups. The NOAEL (reproductive toxicity) is 80 mg/kg bw/day for males and 40 mg/kg bw/day for females. The NOAEL (offspring) is 40 mg/kg bw/day based on significant reduction in pup weights on day 0 and slight reduction in pup weights on day 4 in offspring of the parents dosed with 80 mg/kg bw/day. These adverse effects on the development of the F1-generation occur only in the presence of severe maternal toxicity.
- Executive summary:
In an OECD reproduction/developmental toxicity screening test (OECD TG 421) in rats dicyclohexylamine revealed effects on reproduction only in females at the highest oral dose tested (80 mg/kg bw/day) including slightly reduced gestation index, increase in stillborn pups and decrease in live born pups. The NOAEL (reproductive toxicity) is 80 mg/kg bw/day for males and 40 mg/kg bw/day for females. The NOAEL (offspring) is 40 mg/kg bw/day based on significant reduction in pup weights on day 0 and slight reduction in pup weights on day 4 in offspring of the parents dosed with 80 mg/kg bw/day. These adverse effects on the development of the F1-generation occur only in the presence of severe maternal toxicity.
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