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EC number: 273-521-6 | CAS number: 68988-22-7 A complex residuum from the distillation of products from the manufacture of dimethyl terephthalate by air oxidation and esterification of p-xylene. It consists of polyphenyl polyesters.
- 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:
- 22 September 2009 - 01 October 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study has been performed according to EC and/or OECD guidelines and in compliance with GLP principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 1,4-Benzenedicarboxylic acid, dimethyl ester, manuf. of, by-products from
- EC Number:
- 273-521-6
- EC Name:
- 1,4-Benzenedicarboxylic acid, dimethyl ester, manuf. of, by-products from
- Cas Number:
- 68988-22-7
- Molecular formula:
- Molecular formula, molecular weight range, SMILES notation, InChi and structural formula are not available, because DMT byproducts (CAS # 68988-22-7) is a UVCB subsance.
- IUPAC Name:
- 1,4-Benzenedicarboxylic acid, dimethyl ester, manuf. of, by-products from
- Details on test material:
- - Name of test material (as cited in study report): Terate® 091 Residue
- Substance type: Dark brown solid with soft lumps
- Physical state: Solid
- Analytical purity: 100%
- Composition of test material, percentage of components: by-product from the manufacture of 1,4-Benzenedicarboxylic acid, dimethyl ester
- Lot/batch No.: NB8322-091
- Expiration date of the lot/batch: 14 July 2010
- Stability under test conditions: Stable
- Storage condition of test material: At room temperature in the dark
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan France SARL, Gannat, France
- Age at study initiation: 17-20 weeks
- Weight at study initiation: 2842 - 3222 grams
- Housing:Animals were individually housed in labeled cages with perforated floors and shelters.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.1 - 20.0ºC
- Humidity (%): 45 - 75%
- Air changes (per hr): approximately 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 22 September 2009 To: 01 October 2009
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.5 gram of the unchanged test substance
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- up to 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2x3 cm
- % coverage: 100%
- Type of wrap if used: a metalline patch was mounted on Micropore tape which was wrapped around the abdomen and secured with Coban elastic bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): skin was cleaned of residual test substance using tap water and watery ethanol
- Time after start of exposure: 4 hours
SCORING SYSTEM:
The irritation was assessed according to the following numerical scoring system. At each observation, the highest scores given were recorded:
Erythema and eschar formation:
No erythema: 0
Very slight erythema (barely perceptible): 1
Well-defined erythema: 2
Moderate to severe erythema: 3
Severe erythema (beet redness) *: 4
*. Where signs of necrosis or corrosion (injuries in depth) prevent erythema scoring, the maximum grade for erythema (= 4) is given.
Oedema formation:
No oedema: 0
Very slight oedema (barely perceptible): 1
Slight oedema (edges of area well-defined by definite raising): 2
Moderate oedema (raised approximately 1 millimeter): 3
Severe oedema (raised more than 1 millimeter and extending beyond the area of exposure): 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- other: all animals
- Time point:
- other: 1, 24, 48 and 72 hours after exposure
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no irritation observed
- Irritation parameter:
- edema score
- Basis:
- other: all animals
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no irritation observed
- Irritant / corrosive response data:
- No skin irritation or corrosion was caused by 4 hours exposure.
- Other effects:
- Brown staining of the treated skin by the test substance was observed throughout the observation period, which did not hamper the scoring of the skin reactions.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on these results Terate® 091 Residue does not have to be classified and has no obligatory labeling requirement for skin irritation according to the:
- Regulation (EC) No 1272/2008 on classification, labeling and packaging of substances and mixtures,
- EC criteria for classification and labeling of dangerous substances and preparations (Council Directive 67/548/EEC and all adaptations to technical progress and amendments of this Directive published in the Official Journal of the European Union),
- Globally Harmonized System of Classification and Labeling of Chemicals (GHS) of the United Nations (2007) - Executive summary:
Skin irritancy of the test substance was determined in a guideline study (OECD TG 404) in rabbits. The test substance was found to be not irritating.
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