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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 275-809-7 | CAS number: 71662-46-9
- 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
Endpoint summary
Administrative data
Description of key information
The target substance 1,2-Benzenedicarboxylic acid, di-C8-10-alkyl esters was not sensitising in a study according to OECD 406.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1990-09-10 to 1990-10-12
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Test was performed before REACH enforcement.
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): WITAMOL 118
- Substance type: product
- Physical state: liquid
- Stability under test conditions: not mentioned
- Storage condition of test material: below 40 °C, under nitrogen under a laboratory hood in the dark
- Other: none - Species:
- guinea pig
- Strain:
- other: Dunkin Hartley, Pirbright White
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: F. Winkelmann, Borchen, Germany
- Age at study initiation: 7 to 8 weeks
- Weight at study initiation: 382-487 g
- Housing: 1 - 5 animals in Makrolon cages type IV
- Diet (e.g. ad libitum): G4 complete feed for guinea pigs ad libitum, supplied by Ssniff Spezialfutter GmbH, Soest, Germany
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: 14 days (main test)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 1
- Humidity (%): 40 - 77
- Air changes (per hr): not mentioned
- Photoperiod (hrs dark / hrs light): 12/12 - Route:
- intradermal and epicutaneous
- Vehicle:
- corn oil
- Concentration / amount:
- - Concentrations used for induction: intradermal treatment: approx. 5 % in corn oil; dermal treatment: 100 %
- Concentration in Freunds Complete Adjuvant (FCA): approx. 5 % test substance in a mixture of FCA and corn oil (1:1)
- Concentrations used for challenge: 100 % - No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- - Concentrations used for induction: intradermal treatment: approx. 5 % in corn oil; dermal treatment: 100 %
- Concentration in Freunds Complete Adjuvant (FCA): approx. 5 % test substance in a mixture of FCA and corn oil (1:1)
- Concentrations used for challenge: 100 % - No. of animals per dose:
- test group: 20 animals
control group: 10 animals - Details on study design:
- RANGE FINDING TESTS:
A dose range finding was performed in a preliminary study. 0.1 ml of test substance in corn oil (0, 0.1, 0.5, 1, 2.5, 5 and 10 g test substance/100 ml corn oil) were applied intracutaneously into the left side of two animals. 24 hours after application the skin reactions were assessed. For dermal applications undiluted test substance and concentrations of 10, 20 and 50 g test substance/100 ml corn oil were applied on patches of 2x2 cm to the clipped skin of 4 animals. The patches were removed after 24 hours and dermal reactions were read immediately, 24 and 48 hours after patch removal.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: 1st exposure: intracutaneous injections (0.1 cm³); 2nd exposure: epicutaneous for 48 hours; evaluation after 1 and 24 hours each
- Concentration in Freunds Complete Adjuvants (FCA): test substance in vehicle (5g/100 cm³) in a mixture of FCA and vehicle (1:1)
- Test group: dermal: 100 % test substance (2 x 4 cm patch)
- Control group: vehicle (2 x 4 cm patch)
- Frequency of applications: day 0: intradermal treatment, day 6: pretreatment with sodium dodecyl sulphate (10% in vaseline) and day 7: dermal treatment
- Duration: 3 weeks
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: on day 21
- Exposure period: dermal application for 24 hours
- Test groups: test substance (2 x 2 cm patch)
- Control group: test substance (2 x 2 cm patch)
- Site: left flanks
- Concentrations: 100 %
- Evaluation: 24, 48 and 72 hours after application - Challenge controls:
- see above B. Challenge exposure
- Positive control substance(s):
- not specified
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Key result
- Reading:
- 1st reading
- Group:
- positive control
- Remarks on result:
- other: positive control performed once a year
- Interpretation of results:
- GHS criteria not met
- Executive summary:
1,2-Benzenedicarboxylic acid, di-C8-10-alkyl esters was not sensitising in a study according to OECD 406.
- Endpoint:
- skin sensitisation: in vitro
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin sensitisation study does not need to be conducted because the available in vitro test methods are not applicable for the substance and therefore an in vivo skin sensitisation study was conducted
Referenceopen allclose all
RESULTS OF PILOT STUDY:
- intracutaneous application: well defined erythema and moderate edema at concentrations of 10 g test substance /100 ml corn oil. At concentrations of 0, 0.1, 0.5, 1, 2.5, 5 and 10 g test substance/100 ml corn oil very slight erythema and moderate edema were observed.
- dermal application: no skin reactions at any dose
RESULTS OF TEST
- Sensitization reaction: 0/20
- Clinical signs: no substance specific observations
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The skin sensitising effects of 1,2-Benzenedicarboxylic acid, di-C8-10-alkyl esters and structurally related phthalates was evaluated in animal experiments as well as a human repeat insult patch test (HRIP) with the undiluted substances. No skin sensitisation was observed.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
No evidence of skin sensitisation in animal tests as well as in a human volunteer HPRIT study were found. Hence the test substance is not classified according to Regulation (EC) No 1272/2008.
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.