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EC number: 205-450-3 | CAS number: 141-04-8
- 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:
- 1996
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- OECD Preliminary Reproduction Toxicity Screening Test
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 421 (Reproduction / Developmental Toxicity Screening Test)
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Dibutyl adipate
- EC Number:
- 203-350-4
- EC Name:
- Dibutyl adipate
- Cas Number:
- 105-99-7
- Molecular formula:
- C14H26O4
- IUPAC Name:
- dibutyl adipate
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Details on mating procedure:
- Premating exposure period: male: 14 days; female: 14 days
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- Males: 42 days
Females: from 14 days before mating to day 3 of lactation. - Frequency of treatment:
- Frequency of treatment: 7 day /week
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Dose / conc.:
- 100 mg/kg bw/day (nominal)
- Dose / conc.:
- 300 mg/kg bw/day (nominal)
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 13
- Control animals:
- yes, concurrent vehicle
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Dermal irritation (if dermal study):
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Slight suppression of body weight gain was observed in males in 1,000 mg/kg group, while body weight change in females and food consumption in male and female animals in all compound treated groups were comparable to those in the controls.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- no effects observed
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- no effects observed
- Behaviour (functional findings):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- effects observed, non-treatment-related
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Other effects:
- no effects observed
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- no effects observed
- Reproductive function: sperm measures:
- no effects observed
- Reproductive performance:
- no effects observed
Effect levels (P0)
open allclose all
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- reproductive performance
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 300 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical signs
Target system / organ toxicity (P0)
- Key result
- Critical effects observed:
- no
- Lowest effective dose / conc.:
- 1 000 mg/kg bw/day (nominal)
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Dermal irritation (if dermal study):
- no effects observed
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- pup weight on postnatal days 0 and 4 was slightly decreased along with viability on postnatal day 4.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- no effects observed
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Sexual maturation:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- no effects observed
- Other effects:
- no effects observed
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- no effects observed
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- not examined
Effect levels (F1)
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- ca. 300 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- viability
Target system / organ toxicity (F1)
- Key result
- Critical effects observed:
- no
Overall reproductive toxicity
- Key result
- Reproductive effects observed:
- yes
- Lowest effective dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- Treatment related:
- not specified
- Relation to other toxic effects:
- reproductive effects in the absence of other toxic effects
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Any other information on results incl. tables
Copulation, ovulation, fertility, maintenance of pregnancy, and parturition and lactation were not affected by the test compound.
Reproductive parameters (i.e., duration of gestation, number of corpora lutea, implantations and resorptions, litter size, and sex ratio distribution) were comparable among all four groups including controls. In the 1,000 mg/kg group, pup weight on postnatal days 0 and 4 was slightly decreased along with viability on postnatal day 4. Thus the NOEL was considered to be 1,000 mg/kg/day for reproduction in male and female rats and 300 mg/kg/day for the F1 generation.
Concerning maternal and paternal general toxicity, no mortalities occurred in any group. There were no toxic effects of this chemical on the general condition of male and female animals. Slight suppression of body weight gain was observed in males in 1,000 mg/kg group, while body weight change in females and food consumption in male and female animals in all compound treated groups were comparable to those in the controls. Macroscopic findings at necropsy and histological findings for the internal genitalia showed no abnormalities,. Kidney weights were increased in males and females of the 1,000 mg/kg groups as compared to the control values. Thus the NOEL for general toxicity of this chemical in parent animals was considered to be 300 mg/kg/day.
Applicant's summary and conclusion
- Executive summary:
Type: Fertility [ ]; One generation study [ ];
Two generation study [ ]; Other [X]
Species/strain: Rat/Crj: CD (Sprague-Dawley)
Sex: Female [ ]; Male [ ]; Male/Female [X]; No data [ ]
Route of Administration: Oral gavage
Exposure period: Males: 42 days
Females: from 14 days before mating to day 3 of lactation.
Frequency of treatment: 7 day /week
Postexposure observation periodi:
Premating exposure period: male: 14 days; female: 14 days
Duration of the test;
Doses: 0, 100, 300 or 1,000 mg/kg (13 /animals/sex/group)
Control group: Yes [X]; No [ ]; No data [ ];
Concurrent no treatment [ ]; Concurrent vehicle [X]; Historical [ ]
NOEL Parental: 1,000 mg/kg/day (reproductive effect)
300 mg/kg/day (general toxicity)
NOEL F1 Offspring: 300 mg/kg/day
NOEL F2 Offspring: N/A
Results: Copulation, ovulation, fertility, maintenance of pregnancy, and parturition and lactation were not affected by the test compound. Reproductive parameters (i.e., duration of gestation, number of corpora lutea, implantations and resorptions, litter size, and sex ratio distribution) were comparable among all four groups including controls. In the 1,000 mg/kg group, pup weight on postnatal days 0 and 4 was slightly
decreased along with viability on postnatal day 4. Thus the NOEL was considered to be 1,000 mg/kg/day for reproduction in male and female rats and 300 mg/kg/day for the F1 generation.
Concerning maternal and paternal general toxicity, no mortalities occurred in any group. There were no toxic effects of this chemical on the general condition of male and female animals. Slight suppression of body weight gain was observed in males in 1,000 mg/kg group, while body weight change in females and food consumption in male and female animals in all compound treated groups were comparable to those in the controls. Macroscopic findings at necropsy and histological findings for the internal genitalia showed no abnormalities,.
Kidney weights were increased in males and females of the 1,000 mg/kg groups as compared to the control values. Thus the NOEL for general toxicity of this chemical in parent animals was considered to be 300 mg/kg/day.
Method: OECD Preliminary Reproduction Toxicity Screening Test
GLP: Yes [X] No [ ] ? [ ]
Test substance: Commercial, purity > 99 %
Remarks:
Reference: MHW, Japan (1996a)
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