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Diss Factsheets
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EC number: 201-550-6 | CAS number: 84-66-2
- 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 16 - 31 March 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in 1978 before the introduction of GLP and OECD methodology.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Hagan EC (1959) Acute toxicity in Appraisal of the Safety of chemicals in foods, drugs and cosmetics, pp 17-25
- Principles of method if other than guideline:
- Four groups of 3male and 3 female albino rats were given doses of 1.0, 2.0, 5.0 and 10.0 ml/kg, applied to the shaved mildly abraded skin under an occlusive patch for 24 h then observed for 14 days. The DEP was used as received. Animals were observed for signs of pharmacologic activity and toxicity 1, 3, 6 and 24 hours post application and daily thereafter for a total of 14 days. Animals sacrificed at the end of the 14 day observation period were subjected to a complete gross necropsy.
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Diethyl phthalate
- EC Number:
- 201-550-6
- EC Name:
- Diethyl phthalate
- Cas Number:
- 84-66-2
- Molecular formula:
- C12H14O4
- IUPAC Name:
- .
- Details on test material:
- - Name of test material (as cited in study report): 78-033-2 - Identified as diethyl phthalate (DEP
- Physical state: liquid
- Analytical purity: Not reported
- Lot/batch No.: Not reported
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Summit View Farm, Belvidere, New Jersey, USA
- Age at study initiation: Not reported
- Weight at study initiation: Males: 140 - 170g; females: 154 - 178g
- Fasting period before study: no
- Housing: standard laboratory conditions
- Diet (e.g. ad libitum): Wayne animal feed
- Water (e.g. ad libitum): yes
- Acclimation period: yes, period not specified
ENVIRONMENTAL CONDITIONS
- Temperature (°C): standard laboratory conditions
- Humidity (%): standard laboratory conditions
- Air changes (per hr): standard laboratory conditions
- Photoperiod (hrs dark / hrs light): standard laboratory conditions
IN-LIFE DATES: From: 16 March To: 31 March 1978
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Not reported
- % coverage: 10
- Type of wrap if used: gauze patches covered by an impermeable plastic wrapping
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: immediately
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1.0, 2.0, 5.0 or 10 ml/kg
- Concentration (if solution): 100% as supplied
- Constant volume or concentration used: no
- For solids, paste formed: yes/no
VEHICLE
- Amount(s) applied (volume or weight with unit): N/A
- Concentration (if solution): N/A
- Lot/batch no. (if required): N/A
- Purity: N/A - Duration of exposure:
- 24 hours
- Doses:
- 1.0, 2.0, 5.0 or 10 mL/kg
- No. of animals per sex per dose:
- 3 males and 3 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical signs - 1, 3, 6 and 24 hours following dosing and daily thereafter for a total of 14 days. Body weight recorded at initiation and termination.
- Necropsy of survivors performed: yes - Statistics:
- Not required as there were no deaths and an LD 50 could not be calculated.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 10 mL/kg bw
- Based on:
- test mat.
- Mortality:
- None in any dose group.
- Clinical signs:
- other: Skin slightly reddened in all animals when dressings removed
- Gross pathology:
- No abnormalitities detected
- Other findings:
- None reported
Any other information on results incl. tables
LD50 > 10 ml/kg
Dose Level Sex Dead/dosed % Mortality
(ml/kg) M:F
1.0 3:3 0/3:0/3 0:0
2.0 3:3 0/3:0/3 0:0
5.0 3:3 0/3:0/3 0:0
10.0 3:3 0/3:0/3 0:0
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- LD50 > 10 ml/kg
- Executive summary:
Acute toxicity following administration of a single dermal dose over a 24 hour period has been investigated in the rat. The LD50 was determined to be in excess of 10 mL/kg body weight. This equates to a dose level of 11181 mg/kg when corrected for density.
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