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EC number: 272-945-9 | CAS number: 68921-53-9
- 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
![](https://poisoncentres.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 15 Sep - 16 Oct 1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP - guideline study. In accordance 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:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- 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
- Molecular formula:
- C22H42O4
- IUPAC Name:
- bis(2-ethylhexyl) adipate
- Details on test material:
- - Name of test material (as cited in study report): Di(2-Ethylhexyl) Adipate
- Supplier: ICI France, Department Baleycourt
- Physical state: colourless liquid
- Batch: Y02259/003/003-4
- Analytical purity: 99.2% w/w
- Impurities (identity and concentrations): Phthalate (as DOP) 0.08% w/w
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Alpk:APfSD (Wistar derived)
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: SPF colony maintained at the Animal Breeding Unit, ICI Pharmaceuticals, Alderley Park, Cheshire, UK.
- Age at study initiation: 12 weeks
- Weight at study initiation: 218-278 g
- Housing: individually in stainless steel cages with absorbent paper over collecting trays.
- Diet (e.g. ad libitum): CTI diet, Special Diets Services Ltd., Essex, UK.
- Water (e.g. ad libitum): yes
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-24
- Humidity (%): 44-70
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light):12/12
IN-LIFE DATES: From: 15 Sept - 16 Oct 1987.
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
The experimental diets were prepared in 30 kg batches from premixes. - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Chemical stability was observed at 300 ppm up to at least 32 days. This interval was in excess of the maximum period of use of the first batch of diet (21 days from preparation). The achieved concentration was within 8% of target and the doses received by the test groups were approximately 28, 170 and 1080 mg/kg bw/day.
- Details on mating procedure:
- - Impregnation procedure: cohoused
- If cohoused:
- M/F ratio per cage: not reported
- Length of cohabitation: overnight
- Proof of pregnancy: sperm in vaginal smear referred to as day 1 of pregnancy
Successfully mated females were delivered to the experimental unit.
A total of 96 mated females was supplied over a two week period. - Duration of treatment / exposure:
- days 1-22 of gestation.
- Frequency of treatment:
- Continuous feeding
- Duration of test:
- 22 days
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0, 28, 170 and 1080 mg/kg bw/day
Basis:
other: approximately received doses (as given in study report)
- Remarks:
- Doses / Concentrations:
0, 300, 1800 and 12000 ppm
Basis:
nominal in diet
- No. of animals per sex per dose:
- 24
- Control animals:
- yes, plain diet
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: on arrival and daily
BODY WEIGHT: Yes
- Time schedule for examinations: daily during days 1-22 of gestation
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Yes
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day 22
- Organs examined: uterus, ovaries, liver, spleen, kidney, stomach, rectum, abdominal cavity, pelvic cavity, - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: Yes
- Number of corpora lutea: Yes, in each ovary.
- Number of implantations: Yes
- Number of early resorptions: Yes (early intra-uterine deaths)
- Number of late resorptions: Yes (late intra-uterine deaths)
- Other: Each foetus was weighed and individually identified within the litter by means of a cardboard tag. After weighing the foetuses were killed with an intra-cardiac injection of pentobarbitone. - Fetal examinations:
- - External examinations and cleft palate: Yes, each foetus
- Soft tissue examinations: Yes, all
- Skeletal examinations: Yes, all
- Head examinations: Yes, the head of each foetus was cut along the fronto-parietal suture line and the brain was examined for macroscopic abnormalities. - Statistics:
- Analysis of variance, Student's t-test, Fisher's Exact Test
- Indices:
- - Pre-implantation loss (No. of corpora lutea / No. of implantations)
- Post implantation loss (No. of implantations / No. of live foetuses) - Historical control data:
- Yes, data on variants and frequency of occurence in rats of this strain were given.
Defects like bipartite 5th sternebrae, slightly dilated ureters and kinked ureters were seen in historical controls of this strain.
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
At 12000 ppm a small but statistically significant reduction in maternal bodyweight gain was observed.
There was also a small but statistically significant reduction in food consumption at this dose level from days 2-18 inclusive of gestation.
There was no evidence of maternal toxicity at 300 or 1800 ppm.
Effect levels (maternal animals)
open allclose all
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 170 mg/kg bw/day
- Based on:
- test mat.
- Remarks:
- Equivalent to 1800 ppm in diet.
- Basis for effect level:
- body weight and weight gain
- food consumption and compound intake
- Dose descriptor:
- LOAEL
- Effect level:
- ca. 1 080 mg/kg bw/day
- Based on:
- test mat.
- Remarks:
- Equivalent to 12000 ppm in diet.
- Basis for effect level:
- body weight and weight gain
- food consumption and compound intake
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:yes. Remark: (non-adverse)
Details on embryotoxic / teratogenic effects:
There was no effect at any dose on foetal weight, litter weight, gravid uterus weight, numbers of intra-uterine deaths or numbers of external abnormalities. At 12000 ppm there was a minimal increase of pre-implantation loss with an associated decrease in litter size.
Six major abnormalities (in five foetuses) were seen in the treated groups and eight in the control group (of which seven consisted of multiple minor skull defects in one litter). There was no evidence that the type or distribution of these abnormalities was related to treatment with the test substance.
Overall, minor skeletal defects were increased in a dose-related manner at 1800 and 12000 ppm of the test substance, while skeletal variants (as a percentage of foetuses affected) were increased at the top dose only. These findings indicated slightly poorer ossification at dose levels of 1800 and 12000 ppm, which were considered to be the result of slight fetotoxicity. However, the slightly poorer ossification is not considered as adverse effect.
Effect levels (fetuses)
open allclose all
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 080 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Remarks:
- Equivalent to 12000 ppm in diet.
- Sex:
- male/female
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Dose descriptor:
- LOEL
- Effect level:
- ca. 170 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Remarks:
- Equivalent to 300 ppm in diet.
- Sex:
- male/female
- Basis for effect level:
- other: delayed ossification
- Dose descriptor:
- NOEL
- Effect level:
- ca. 28 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Remarks:
- Equivalent to 1800 ppm in diet.
- Sex:
- male/female
- Basis for effect level:
- other: delayed ossification
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
Table 1: Foetal defects and variants - Intergroup comparison of foetal defects and variants
|
Dietary conc. of DEHA (ppm) |
|||
0 |
300 |
1800 |
12000 |
|
No. of litters examined |
24 |
23 |
24 |
23 |
External and visceral defects |
||||
No. of foetuses examined |
282 |
263 |
278 |
243 |
No. of foetuses showing major defects |
1 |
2 |
0 |
2 |
No. of foetuses showing minor defects only |
7 |
8 |
9 |
3 |
Variants |
||||
No. of foetuses showing variants |
69 |
69 |
81 |
78* |
Skeletal defects |
||||
No. of foetuses examined |
282 |
263 |
278 |
243 |
No. of foetuses showing major defects |
7 |
0 |
1 |
1 |
No. of foetuses showing minor defects only |
70 |
78 |
97** |
120** |
Variants |
||||
No. of foetuses showing variants |
270 |
257 |
268 |
243** |
Table 2: Summary of the type and incidence of major defects
|
Dietary conc. of DEHA (ppm) |
|||
0 |
300 |
1800 |
12000 |
|
External/Visceral |
||||
Situs inversus totalis |
0 |
0 |
0 |
1 |
Left adrenal, kidney and ureter absent |
1 |
0 |
0 |
0 |
Cysts attached to liver |
0 |
1 |
0 |
0 |
Small right kidney |
0 |
1 |
0 |
0 |
Umbilical hernia |
0 |
0 |
0 |
1 |
Skeletal |
||||
Skull: Multiple minor defects |
7 |
0 |
0 |
0 |
3rdand 7thribs (left) not ossified0 |
0 |
0 |
0 |
1 |
1strib (right) partially ossified |
0 |
0 |
1 |
0 |
There was no evidence that the test substance is teratogenic to the rat at any of the dose levels tested (up to 12000 ppm -approximately 1000 mg/kg/day). Administration of 12000 ppm DEHA resulted in slight maternal toxicity and slight foetotoxicity.
At 1800 ppm, there was no evidence of maternal toxicity although minimal foetotoxicity was observed. A dietary level of 300 ppm DEHA was a clear no-effect level for embryonic development.
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.
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