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EC number: 203-672-5 | CAS number: 109-43-3
- 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
Toxicity to reproduction
Administrative data
- Endpoint:
- one-generation reproductive toxicity
- Remarks:
- based on test type (migrated information)
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- weight of evidence
- Study period:
- 10 Aug 1987 - 12 Jan 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP - Guideline study. According to the ECHA guidance document "Practical guide 6: How to report read-across and categories (March 2010)", the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
- Reference Type:
- secondary source
- Title:
- Diesters Category of the Aliphatic Esters Chemicals (Test Plan and Robust Summaries for Substances in the HPV Test Plan)
- Author:
- US-EPA (American Chemistry Council's Aliphatic Esters Panel)
- Year:
- 2 010
- Bibliographic source:
- High Production Volume (HPV) Chemical Challenge Program (201-16837A and 201-16837B)
- Reference Type:
- secondary source
- Title:
- Bis(2-ethylhexyl)adipate (DEHA) CAS N°: 103-23-1
- Author:
- OECD
- Year:
- 2 000
- Bibliographic source:
- SIDS Initial Assessment Report for SIAM 10; Tokyo, Japan, 15-17 March 2000
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 415 [One-Generation Reproduction Toxicity Study (before 9 October 2017)]
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Bis(2-ethylhexyl) adipate
- EC Number:
- 203-090-1
- EC Name:
- Bis(2-ethylhexyl) adipate
- Cas Number:
- 103-23-1
- IUPAC Name:
- bis(2-ethylhexyl) adipate
- Details on test material:
- - Name of test material (as cited in study report): Di-(2-ethylhexyl) Adipate (DEHA)
- Physical state: clear liquid
- Analytical purity: 99.2% w/w
- Batch No: Y02259/003/001
- Storage: in a ventilated cupboard at 20 ºC
- Stability: Chemical stability of DEHA in diet was determined on three batches of diet at nominally 300 and 12000 ppm. Satisfactory chemical stability was established for diet stored at room temperature for up to 34 days.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Alpk:APfSD (WIstar-derived)
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on mating procedure:
- - M/F ratio per cage: 1/2
- Length of cohabitation: 10 days
- Proof of pregnancy: sperm in vaginal smear referred to as day 1 of pregnancy
- After 10 days of unsuccessful pairing replacement of first male by another male with proven fertility.
- Further matings after two unsuccessful attempts: no
- After successful mating each pregnant female was caged (how): individually
In all pairings brother sister mating was avoided. - Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- (P) Males: 10 weeks before mating.
(P) Females: 10 weeks before mating
After 10 weeks, the animals were mated to produce a single litter (F1A) which were reared to day 36 post partum.
Test diets were fed continuously throughout the study. - Frequency of treatment:
- continuously
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
300, 1800 and 12000 ppm
Basis:
nominal in diet
- Remarks:
- Doses / Concentrations:
304, 1038 and 11840 ppm
Basis:
other: analytical
- Remarks:
- Doses / Concentrations:
approx. 52, 178 and 2102 mg/kg bw/day for males and 61, 203 and 2399 mg/kg bw/day for females
Basis:
other: The values were calculated by the mean body weights and the mean food consumption with the analytical compound values
- No. of animals per sex per dose:
- 15 males
30 females - Control animals:
- yes, plain diet
Results and discussion
Results: P0 (first parental generation)
Effect levels (P0)
open allclose all
- Dose descriptor:
- NOAEL
- Remarks:
- fertility
- Effect level:
- >= 2 102 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: see 'Remark'
- Dose descriptor:
- NOAEL
- Remarks:
- fertility
- Effect level:
- >= 2 399 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: see 'Remark'
- Dose descriptor:
- NOAEL
- Remarks:
- systemic
- Effect level:
- 178 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: The nominal dose was 1800 ppm in diet.
- Dose descriptor:
- NOAEL
- Remarks:
- systemic
- Effect level:
- 203 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: The nominal dose was 1800 ppm in diet.
- Dose descriptor:
- LOAEL
- Remarks:
- systemic
- Effect level:
- 2 102 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: The nominal dose was 12000 ppm in diet. An increase in liver weight was observed in both male and female parents receiving 12000 ppm DEHA.
- Dose descriptor:
- LOAEL
- Remarks:
- systemic
- Effect level:
- 2 399 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: The nominal dose was 12000 ppm in diet. An increase in liver weight was observed in both male and female parents receiving 12000 ppm DEHA. Reduction in bodyweight gain during gestation in the 12000 ppm DEHA group compared with controls.
Results: F1 generation
Effect levels (F1)
open allclose all
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 178 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: Mean pup weight gain and total litter weight were reduced at the highest dose. Litter size was slightly reduced throughout the post-partum period at the highes dose.
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 203 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: Mean pup weight gain and total litter weight were reduced at the highest dose. Litter size was slightly reduced throughout the post-partum period at the highest dose.
- Dose descriptor:
- LOAEL
- Generation:
- F1
- Effect level:
- 2 102 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: Mean pup weight gain and total litter weight were reduced. Slighly reduction in litter size throughout the post-partum period.
- Dose descriptor:
- LOAEL
- Generation:
- F1
- Effect level:
- 2 399 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: Mean pup weight gain and total litter weight were reduced. Slighly reduction in litter size throughout the post-partum period.
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
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.
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.