Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 248-368-3 | CAS number: 27253-26-5
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- 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:
- Developmental Toxicity Study in Rats with Diisodecyl Phthalate
- Author:
- Nikiforov AI, et al
- Year:
- 1 995
- Bibliographic source:
- Toxicol Letters 78(Suppl 1):61
- Reference Type:
- publication
- Title:
- Developmental Toxicity of Di-isodecyl and Di-isononyl Phthalates In Rats
- Author:
- Waterman SJ, Ambroso JL, Keller LH, Trimmer GW, Nikiforov AI and Harris SB
- Year:
- 1 999
- Bibliographic source:
- Reproductive Toxicology 13(2):131-136
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.31 (Prenatal Developmental Toxicity Study)
- Version / remarks:
- Cited as Directive 87/302/EEC, part B, p. 24
- GLP compliance:
- not specified
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
- IUPAC Name:
- bis(8-methylnonyl) phthalate
- Details on test material:
- - Name of test material (as cited in study report): di-isodecyl phthalate
- CAS RN 68515-49-1
Constituent 1
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:no effects
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
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). It is currently admitted that the litter is the preferred unit for developmental toxicity studies in order to avoid exaggeration of the level of significance. Therefore, only the effects observed at 1000 mg/kg/day are considered to set a NOAEL. As recognized in the EU Risk Assessment Report for DIDP, the NOAEL for the conceptus can be assumed to be 500 mg/kg/day based on significant increase of skeletal variation on a per litter basis at the high dose of 1000 mg/kg/day.
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.
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.