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EC number: 230-072-0 | CAS number: 6938-94-9
- 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from a peer reviewed journal.
Data source
Reference
- Reference Type:
- publication
- Title:
- Embryonic-Fetal Toxicity and Teratogenic Effects of Adipic Acid Esters in Rats
- Author:
- Singh, A .R ., Lawrence, W .H ., and Autian, J
- Year:
- 1 973
- Bibliographic source:
- Journal of Pharmaceutical Sciences. VoL 62, No. 10 October 1973:1596-1600
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: OECD 414 (PreNatal Developmental Toxicity Screening Test)
- Principles of method if other than guideline:
- The above experiment was performed to evaluate and assess the effect of the test chemical on the maternal animals and on the fetus of the treated maternal animals.
- GLP compliance:
- not specified
- Justification for study design:
- No Data Available
Test material
- Reference substance name:
- Diisopropyl adipate
- EC Number:
- 230-072-0
- EC Name:
- Diisopropyl adipate
- Cas Number:
- 6938-94-9
- Molecular formula:
- C12H22O4
- IUPAC Name:
- 1,6-bis(propan-2-yl) hexanedioate
- Test material form:
- liquid
- Details on test material:
- SOURCE OF TEST MATERIAL
- Identification: Di isopropyl adipate (CAS No. - 6938-94-9)
- Source of test material: Sustainability Support Services (Europe) AB
- Appearance: Colourless Liquid
- Batch No.of test material: Lot 1/05
- Manufactured date: Not provided
- Expiration date of the lot/batch: Not provided
- Purity: 99.55%
RADIOLABELLING INFORMATION (not applicable)
- Radiochemical purity: N/A
- Specific activity: N/A
- Locations of the label: N/A
- Expiration date of radiochemical substance: N/A
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Stored in cool place. Kept container tightly closed in a dry and well- ventilated place.
- Stability under test conditions: No data available
- Solubility and stability of the test substance in the solvent/vehicle: No data available
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: No data available
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: No data available
- Preliminary purification step (if any): No data available
- Final dilution of a dissolved solid, stock liquid or gel: No data available
- Final preparation of a solid: No data available
FORM AS APPLIED IN THE TEST (if different from that of starting material): No data available
OTHER SPECIFICS:
- Safety precautions: Avoided contact with skin and eyes. Avoided inhalation of vapour or mist. Normal measures for preventive fire protection were taken. Aprons, caps, mask, gloves and goggles were used to ensure the health and safety of the personnel.
- Disposal: The remaining unused test item was disposed as per internal SOPs of sa-FORD and the same was documented in the raw data.
Constituent 1
- Specific details on test material used for the study:
- - Appearance: Colourless Liquid
- Molcular weight: 230.302 g/mol
- Substance type: Organic
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on species / strain selection:
- No Data Available
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: No Data Available
- Age at study initiation: No Data Available
- Weight at study initiation: Females: 175-225 g.
- Fasting period before study: No Data Available
- Housing: The test animals were housed in the individual cages.
- Use of restrainers for preventing ingestion (if dermal): no
- Diet (e.g. ad libitum): Food was provided ad libitum.
- Water (e.g. ad libitum): Fresh tap was provide ad libitum.
- Acclimation period: No Data Available
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-27°C
- Humidity (%): No Data Available
- Air changes (per hr): No Data Available
- Photoperiod (hrs dark / hrs light): No Data Available
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- Details on exposure
PREPARATION OF DOSING SOLUTIONS: The test chemical was administered to the animals in at four dosage levels: one-thirtieth, one-tenth, one-fifth, and one-third of their acute LD-50 values.
DIET PREPARATION
- Rate of preparation of diet (frequency): No Data Available
- Mixing appropriate amounts with (Type of food):No Data Available
- Storage temperature of food: No Data Available
VEHICLE
- Justification for use and choice of vehicle (if other than water): No Data Available
- Concentration in vehicle: No Data Available
- Amount of vehicle (if gavage): No Data Available
- Lot/batch no. (if required): No Data Available
- Purity: No Data Available - Details on mating procedure:
- Details of mating
- M/F ratio per cage: (1:5) Five female rats were housed with one male.
- Length of cohabitation: Mating was conducted on 13 days.
- Proof of pregnancy: [vaginal plug / sperm in vaginal smear] referred to as [day 0 / day 1] of pregnancy: The onset of gestation was established by the presence of sperm in the vaginal smear and was designated as Day 0, with the following day being Day 1 of the gestation period.
- After ... days of unsuccessful pairing replacement of first male by another male with proven fertility. No Data Available
- Further matings after two unsuccessful attempts: [no / yes (explain)] No Data Available
- After successful mating each pregnant female was caged (how): The female rats were moved to individual cages, where they were kept undisturbed except for specified injections.
- Any other deviations from standard protocol: No Data Available - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No Data Available
- Duration of treatment / exposure:
- No Data Available
- Frequency of treatment:
- No Data Available
- Details on study schedule:
- No Data Available
Doses / concentrations
- Remarks:
- 0.1262, 0.3786, 0.7572 and 1.2619 ml/kg bw intraperitoneally
- No. of animals per sex per dose:
- There were 31 groups, each composed of five female rats.
- Control animals:
- not specified
- Details on study design:
- No Data Available
- Positive control:
- No Data Available
Examinations
- Parental animals: Observations and examinations:
- On the 20th day of gestation, 1 day prior to expected parturition, the rats were sacrificed by ether inhalation. The uterine horns and ovaries were surgically exposed to permit counting and recording of the numbers of corpora lutea, resorption sites, and viable and dead fetuses.
- Oestrous cyclicity (parental animals):
- Female rats were selected for experimentation only after observation of at least two complete 4- or 5-day estrus cycles. Occurrence of estrus was determined by daily vaginal smears, obtained by introducing 0.2 ml. of fresh, clean tap water into the vagina with a smooth. clean. sterile medicine dropper, withdrawing a part of the liquid, and transferring it to a clean slide. The slide was examined microscopically while fresh, and the stage of estrus (proestrus, metestrus, or diestrus) was determined according to cell types found in the vaginal smear.
- Sperm parameters (parental animals):
- No Data Available
- Litter observations:
- The following parameters of adverse effects were investigated:
(a) embryonic-fetal toxicity, as evidenced by resorptions and stillbirths,
(b) gross (external) malformations of fetuses,
(c) skeletal malformations.
(d) visceral abnormalities, and
(e) fetal size (weight).
In all evaluations. both viable and nonviable fetuses were considered - Postmortem examinations (parental animals):
- On the 20th day of gestation, 1 day prior to expected parturition, the rats were sacrificed by ether inhalation. The uterine horns and ovaries were surgically exposed to permit counting and recording of the numbers of corpora lutea, resorption sites, and viable and dead fetuses.
- Postmortem examinations (offspring):
- (b) gross (external) malformations of fetuses,
(c) skeletal malformations.
(d) visceral abnormalities were observed. - Statistics:
- No Data Available
- Reproductive indices:
- Implantation Index, Resorption Index, Uterine Index.
- Offspring viability indices:
- Fetal viability index.
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- 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:
- not specified
- 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:
- no effects observed
Details on results (P0)
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 1.262 other: ml/Kg
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- gross pathology
- reproductive performance
- Remarks on result:
- other: Not Specified
Target system / organ toxicity (P0)
- Critical effects observed:
- not specified
- System:
- other: Not Specified
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- no mortality observed
- Description (incidence and severity):
- No mortality was observed at any treated dose levels of the tes chemical.
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not specified
- 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
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- No significant effects on gross abnormalities except some sporadic cases of skeletal and visceral malformations were observed in the fetus treated with the test chemical.
- Histopathological findings:
- not specified
- Other effects:
- not specified
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- not specified
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- not specified
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 1.127 other: ml/Kg
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- viability
- mortality
- body weight and weight gain
- gross pathology
- Remarks on result:
- other: Not Specified
Target system / organ toxicity (F1)
- Critical effects observed:
- not specified
- System:
- other: Not Specified
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
- Treatment related:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Based on all the observations and results, it was concluded that the NOAEL for the test chemical was 1.269 ml/Kg bw.
- Executive summary:
A study was performed to evaluate and assess the effect of the test chemical on the maternal animals and on the fetus of the treated maternal animals. In this study, the test chemical was administered to the test animals via the intraperitoneal route at doses of 0.1262, 0.3786, 0.7572 and 1.2619 ml/kg bw. Female rats were selected for experimentation only after observation of at least two complete 4- or 5-day estrus cycles. Occurrence of estrus was determined by daily vaginal smears, obtained by introducing 0.2 ml. of fresh, clean tap water into the vagina with a smooth. clean. sterile medicine dropper, withdrawing a part of the liquid, and transferring it to a clean slide. The slide was examined microscopically while fresh, and the stage of estrus (proestrus, metstrus, or diestrus) was determined according to cell types found in the vaginal smear. Test animals were adult, virgin female, Sprague-Dawley rats, weighing 175-225 g. Adult, male rats of this strain were utilized as the “stud pool.” Five female rats were housed with one male in a large cage at room temperature (22-27“) with foods and fresh tap water provided ad libitum. The onset of gestation was established by the presence of sperm in the vaginal smear and was designated as Day 0. with the following day being Day 1 of the gestation period. At this time, the female rats were moved to individual cages, where they were kept undisturbed except for specified injections. There were 31 groups, each composed of five female rats. All treatments were administered by intraperitoneal injection on the 5th, 10th, and 15th days of gestation. On the 20th day of gestation, 1 day prior to expected parturition, the rats were sacrificed by ether inhalation. The uterine horns and ovaries were surgically exposed to permit counting and recording of the numbers of corpora lutea, resorption sites, and viable and dead fetuses. The following parameters of adverse effects were investigated, embryonic-fetal toxicity, as evidenced by resorptions and stillbirths, gross (external) malformations of fetuses, skeletal malformations, visceral abnormalities, and fetal size (weight). In all evaluations. both viable and nonviable fetuses were considered. After treatment it was observed that, only one resorption site was ohserved in the test chemical group. No other gross pathological effects were observed in the test chemical treated group. No effects on the estrous cyclicity of the maternal animals was observed. Also, no effects on the reproductive parameters was observed. In fetal examinations, no effects on the body weights and the viability of the fetus was observed. Also, no significant effects on gross abnormalities except some sporadic cases of skeletal and visceral malformations were observed in the fetus treated with the test chemical. Thus, based on all the observations and results, it was concluded that the NOAEL for the test chemical was 1.269 ml/Kg bw.
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