Registration Dossier
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EC number: 271-091-4 | CAS number: 68515-49-1
- 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

Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study is rated a "1" because it applied GLP, used appropriate testing procedures, and followed an accepted test guideline.
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 995
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 999
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Official Journal of European Communities L 133 Methods for Determination of Toxicity, Teratogenicity (Annex V, Adopted November 18, 1987)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 1,2-Benzenedicarboxylic acid, di-C9-11-branched alkyl esters, C10-rich
- EC Number:
- 271-091-4
- EC Name:
- 1,2-Benzenedicarboxylic acid, di-C9-11-branched alkyl esters, C10-rich
- Cas Number:
- 68515-49-1
- Molecular formula:
- C28 H46 O4
- IUPAC Name:
- Not available; not a single isomer substance (see remarks below)
- Reference substance name:
- 1,2-benzenedicarboxylic acid, di-C9,C10 and C11 branched alkyl ester, C10 Rich
- IUPAC Name:
- 1,2-benzenedicarboxylic acid, di-C9,C10 and C11 branched alkyl ester, C10 Rich
- Details on test material:
- - Name of test material (as cited in study report): di-isodecyl phthalate
- CAS RN 68515-49-1
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Inc
- Age at study initiation: 9 weeks
- Weight at study initiation: 210 to 270 g
- Fasting period before study:
- Housing: Single house during the study period, except during mating
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 13 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 24.4
- Humidity (%): 40 to 70
- Photoperiod: 12 hrs dark / 12 hrs light
Administration / exposure
- Route of administration:
- oral: gavage
- Details on mating procedure:
- - Impregnation procedure: cohoused
- If cohoused:
- 1:1 M/F ratio per cage:
- Length of cohabitation: until observation of proof of pregnancy.
Mated females returned to individual cages. New females placed in males'cages until required number of mated females obtained for study.
- Proof of pregnancy: vaginal plug / sperm in vaginal smear, referred to as day 0 of pregnancy - Duration of treatment / exposure:
- Gd 6 through 15
- Frequency of treatment:
- daily
- Duration of test:
- All females euthanised on GD21
Doses / concentrations
- Remarks:
- Doses / Concentrations:
100, 500, 1000 mg/kg
Basis:
actual ingested
- No. of animals per sex per dose:
- no males; up to 25 mated females / dose
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Sex: male/female
Duration of test: gestation day 21
Results and discussion
Results: maternal animals
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 500 mg/kg bw/day
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- 500 mg/kg bw/day
- Basis for effect level:
- other: developmental toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:yes
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
RS-Freetext:
Maternal toxicity was indicated by reductions in body weight gain and food consumption. There was no
evidence of malformations or fetal toxicity.
Developmental effects: There were no significant differences in mean foetal body weight and no statistically
significant increases in total or individual external, visceral or skeletal malformations in the treated group
when compared with controls. The only visceral variation observed was a single incidence of dilated renal
pelves in the mid group. Three controls, one low-dose, three mid-dose, and six high-dose foetuses were
stunted. Those observations were considered incidental and unrelated to treatment. There was a dose-
related increase in total foetuses with skeletal variations on both a per foetus basis (38/196, 35/177, 61/193,
123/196) and a per litter basis (18/25, 17/22, 20/24, 23/24) at a dose of 0-100-500-1,000 mg/kg, respectively.
When compared with controls, rudimentary lumbar ribs and cervical ribs were dose-related significantly
increased (p 0.01) in the mid and high-dose groups on a per foetus basis (21%, 52% versus 8.2% in control
group and 6.2%, 9.2% versus 1% in control group, respectively; the historical control ranges are 3.7-21.6%
and 0.54-4.0%, respectively) and in the high-dose group on a per litter basis (23/24 vs. 10/24 for rudimentary
lumbar ribs and 10/24 vs. 2/25 for rudimentary cervical ribs).
Applicant's summary and conclusion
- Conclusions:
- The results indicate that DIDP was neither a selective developmental toxicant nor an embryotoxic agent.
- Executive summary:
In regard with developmental effects, skeletal variations are observed in the developmental studies at 1,000 mg/kg/d concurrently with slight signs of maternal toxicity and lead to a NOAEL of 500 mg/kg/d.
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