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Diss Factsheets
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EC number: 201-873-2 | CAS number: 88-99-3
- 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: in vivo (non-LLNA)
- Remarks:
- in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: No OECD Guideline or GLP defined. No test material concentration and dose defined.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 981
Materials and methods
- Principles of method if other than guideline:
- A modification of the Maguire method was adopted. The method derives from the "Split-adjuvant" technique, in which chemical allergen and Freund´s adjuvant are administered separately to the skin rather than as an emulsion.
- GLP compliance:
- not specified
- Type of study:
- other: Maguire method
- Justification for non-LLNA method:
- The test was performed before the LLNA method was validated.
Test material
- Reference substance name:
- Phthalic acid
- EC Number:
- 201-873-2
- EC Name:
- Phthalic acid
- Cas Number:
- 88-99-3
- Molecular formula:
- C8H6O4
- IUPAC Name:
- benzene-1,2-dicarboxylic acid
- Details on test material:
- 1,2-Benzene-dicarboxylic acid
Constituent 1
- Specific details on test material used for the study:
- substance is called 1,2-benzene-dicarboxylic acid (compound No. 23)
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- other: epicutaneous, no further data given
- Vehicle:
- no data
- Concentration / amount:
- no data
Challengeopen allclose all
- Route:
- other: epicutaneous, no further data given
- Vehicle:
- no data
- Concentration / amount:
- no data
- No. of animals per dose:
- 10
- Details on study design:
- Prior to conducting the sensitization test, the test material was applied as recieved on the clipped flanks of guinea pigs to determine if primary irritation would occur. If significant irritation was observed, dilutions of the test material were made in a suitable solvent. The highest concentration which did not caus primary irritation was used for the test.
The test procedure consisted of topical application of a 0.1 ml aliquot of the test material to the clipped and depilated backs of 10 guinea pigs for four times in 10 days. At the time of the third application, 0.2 ml of Freund´s adjuvant was injected intradermally at one point adjacent to the insult site. After a 2-week rest period, the guinea pigs were challenged on the clipped flanks with the test material on one flank and a solvent on the other flank. The challenge site was evaluated for erythema and edema at 24 and 48 hours. A moderate erythema and/or edema in two or more guinea pigs would be considered sufficient to classify the test material as a potential human skin sensitizer. - Positive control substance(s):
- yes
- Remarks:
- Epichlorohydrin and diglycidyl ether of 2,2-di-(p,p'-hydroxyphenyl)propane
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- no data
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no data
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: no data. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no data.
- Group:
- positive control
- Remarks on result:
- other: diglycidiylether of 2,2-di-(p,p'-hydroxyphenyl)propane
- Group:
- negative control
- Remarks on result:
- other: Various chemical groups were evaluated for their skin sensitisation potential in guinea pigs. Therefore a sufficient basis for a negative control is available.
Any other information on results incl. tables
0 of 10 tested animals showed effects.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Executive summary:
In a modiefied method of the Maguire method the test procedure consisted of topical application of a 0.1 ml aliquot of the test material to the clipped and depilated backs of 10 Hartley guinea pigs for four times in 10 days. At the time of the third application, 0.2 ml of Freund´s adjuvant was injected intradermally at one point adjacent to the insult site. After a 2-week rest period, the guinea pigs were challenged on the clipped flanks with the test material on one flank and a solvent on the other flank. The challenge site was evaluated for erythema and edema at 24 and 48 hours. A moderate erythema and/or edema in two or more guinea pigs was considered sufficient to classify the test material as a potential human skin sensitizer. In 0/10 animals effects were observed, therefore the test substance was not found to be sensitising.
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