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EC number: 215-951-9 | CAS number: 1459-93-4
- 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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation
- Remarks:
- in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Reliable scientific study from a reputable laboratory.
Data source
Reference
- Reference Type:
- publication
- Title:
- Comparison of the local lymph node assay with the guinea-pig maximization test for the detection of a range of contact allergens
- Author:
- Basketter DA and Scholes EW
- Year:
- 1 992
- Bibliographic source:
- Food Chem. Toxic. 30(1): 65-69
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Principles of method if other than guideline:
- GPMT and LLNA validation study
- GLP compliance:
- no
- Type of study:
- other: Guinea Pig Maximization test and murine local lymph node assay
Test material
- Reference substance name:
- Dimethyl isophthalate
- EC Number:
- 215-951-9
- EC Name:
- Dimethyl isophthalate
- Cas Number:
- 1459-93-4
- Molecular formula:
- C10H10O4
- IUPAC Name:
- 1,3-dimethyl benzene-1,3-dicarboxylate
- Test material form:
- not specified
- Details on test material:
- source: BP (Guildford, surrey, UK), at least 98% pure.
Constituent 1
In vivo test system
Test animals
- Species:
- other: guinea pig and mouse
- Strain:
- other: Albino dunkin-Hartley guinea pig and CBA/Ca mice
- Sex:
- male/female
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: A/P (acetone: polyethylene glycol 400 (70:30, v/v)).
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: A/P (acetone: polyethylene glycol 400 (70:30, v/v)).
- No. of animals per dose:
- 4
- Details on study design:
- The Magnusson and Kligman guinea-pig maximization test. The test method carried out is based on and similar to that described by Magnusson and Kligman (1970). Albino Dunkin—Hartley guinea-pigs weighed approximately 350 g at the start of the study. Preliminary irritation tests were carried out to determine the concentrations of the test substances suitable for induction of sensitization and for sensitization challenge. Guinea-pigs were then treated by a series of six intradermal injections in the shoulder region to induce sensitization. After 6-8 days, sensitization was boosted by a 48-hr occluded patch placed over the injection site. 12-14 days later, the animals were challenged on one flank by a 24-hr occluded patch at the maximum non-irritant concentration. Challenge sites were scored for erythema (scale 0-3) and oedema 24 and 48 hr after removal of the patches.
- Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- No. with + reactions:
- 0
- Clinical observations:
- evaluated as negative in the GPMT
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. No with. + reactions: 0.0. Clinical observations: evaluated as negative in the GPMT.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- No. with + reactions:
- 0
- Clinical observations:
- evaluated as negative in the GPMT
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. No with. + reactions: 0.0. Clinical observations: evaluated as negative in the GPMT.
Any other information on results incl. tables
In the GMPT assay, DMIP had a 0% response and was classified as a non-sensitizer.
In the LLNA assay, DMIP had a "test to control lymphocyte proliferation index" (dpm/node) of 1.0, and was classified as a non-sensitizer.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Dimethyl isophthalate (DMIP) was part of a series of chemicals tested to validate the murine local lymph node assay (LLNA), by testing in both the guinea pig maximization test (GPMT) and the LLNA. In both studies, DMIP was inactive, and was evaluated as non-sensitizing. The substance is not classified as a dermal sensitizer according to Regulation EC No. 1272/2008.
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