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EC number: 271-090-9 | CAS number: 68515-48-0
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15.12.1995 to 26 .12 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: A GLP compliant study undertaken to a standard considered to be equivalent to international test guidelines for a primary skin irritation study.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Principles of method if other than guideline:
- There is no explicit statement in the report that the study was undertaken in accordance with a specific guideline, although there is a reference to 'OECD 1992 test guideline 404'.
- GLP compliance:
- yes
Test material
- Reference substance name:
- 1,2-Benzenedicarboxylic acid, di-C8-10-branched alkyl esters, C9-rich
- EC Number:
- 271-090-9
- EC Name:
- 1,2-Benzenedicarboxylic acid, di-C8-10-branched alkyl esters, C9-rich
- Cas Number:
- 68515-48-0
- Molecular formula:
- C26 H42 O4
- IUPAC Name:
- 1,2-Benzenedicarboxylic acid, di-C8-10-branched alkyl esters, C9-rich
- Reference substance name:
- DINP
- IUPAC Name:
- DINP
- Details on test material:
- - Name of test material (as cited in study report): Di-isononyl phthalate
- Substance type: Technical material
- Physical state: Colourless liquid
- pH : 6 (determined by the laboratory)
- Stability under test conditions: No data
- Storage condition of test material: Room temperature
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: HRP Inc.,Denver, PA, USA
- Age at study initiation: Approximately 13-14 weeks
- Weight at study initiation: 2.29 to 2.49 kg
- Housing:Single housing in suspended stainless steel and wire mesh cages with absorbent paper below.
- Diet (e.g. ad libitum): Fixed amount daily
- Water (e.g. ad libitum): Ad libitum
- Acclimation period:10 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 65-70°F
- Humidity (%): 40-60% RH
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light):Approximately 12 hours dark/12 hours light
IN-LIFE DATES: From: 21 December 1995 To:26 December 1995
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml per animal
- Concentration (if solution): Undiluted test material
- Duration of treatment / exposure:
- Four hours
- Observation period:
- 72 hours
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: 1 inch X 1 inch
- Type of wrap if used: gauze patch held in place by non-irritating tape and a semi-occluded dressing, and protected by a neck collar during the exposure period.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiped using peanut oil and paper towel
- Time after start of exposure: 4 hours
SCORING SYSTEM:Draize 1959
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0.17
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Very slight erythema (barely perceptible) (Grade 1) observed in one rabbit at the 6 hour examination and one different rabbit at the 24 hour examination. The scores for erythema and oedema were 'Grade 0' (No response) at all other occasions of examination.
- Other effects:
- There were no other effects of treatment.
Any other information on results incl. tables
Dermal reactions to treatment were confined to very slight erythema (barely perceptible) in single animals at the 1 or 24 hour examinations. Individual dermal scores are appended in the 'attached background information' window below.
1) The mean erythema and oedema scores for each time interval are:
1 hr |
24 hr |
48 hr |
72 hr |
|
Erythema |
0.17 |
0.17 |
0.00 |
0.00 |
Oedema |
0.00 |
0.00 |
0.00 |
0.00 |
Mean erythema and oedema scores for 24, 48 and 72 hours are: Erythema: 0.06 Oedema: 0.00 2)The primary irritation index, as calculated by the modified Draize method, is: 0.08
Applicant's summary and conclusion
- Interpretation of results:
- other: very mild skin irritant
- Remarks:
- Criteria used for interpretation of results: other: Draize method
- Conclusions:
- The test material is an extremely mild skin irritant to rabbits
- Executive summary:
In a 72 hour primary skin irritation study, 6 rabbits (New Zealand White) were exposed to a 4 hour semi-occluded application of 0.5 ml of undiluted di-isononyl phthalate to 1x1 inch.of clipped doral skin, and the sites examined 1, 24, 48 and 72 hours after treatment. Irritation responses were confined to very slight erythema in single rabbits at the1or 24 hour examinations. The primary skin irritation index was 0.08, and the test material was considered to be an extremely mild skin irritant.
The study was considered suitable for classification, and satisfied the guideline requirements for rabbit primary skin irritation studies.
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