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EC number: 214-527-0 | CAS number: 1141-38-4
- 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: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- March 16, 1981 (animal receipt) to June 30, 1981 (final report issued)
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPP 81-6 (Skin Sensitisation)
- Deviations:
- no
- Principles of method if other than guideline:
- This study was peformed at Bio/dynamics, Inc. Mettlers Road, Est Millstone, New Jersey 08873. The procedures used were based on the methods described by E.V. Buehler in "Delayed contact Hypersensitivity in the guinea Pig" Arch. Dermatol 91: 171-175 (1965) and H.L. Ritz and E.V Buehler in "Planning, conduct and Interpretation of Guinea Pig Sensitization Patch Tests" in Current Concepts in Cutaneous toxicity (Victor A. Drill and Paul Lazar, eds.) pp. 25-40 Academic press, 1980.
- GLP compliance:
- no
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- This study was conducted before the LLNA guidelines were even being discussed
Test material
- Reference substance name:
- Naphthalene-2,6-dicarboxylic acid
- EC Number:
- 214-527-0
- EC Name:
- Naphthalene-2,6-dicarboxylic acid
- Cas Number:
- 1141-38-4
- Molecular formula:
- C12H8O4
- IUPAC Name:
- naphthalene-2,6-dicarboxylic acid
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- 2,6-naphthalene was held confidential in the report and suppled as C-217. It was supplied by Celanese as very fine white powder, for storage at room temperature. The suggested vehicle was paraffin oil.
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- 40 (21 males and 19 females) Hartley Albino Guinea Pigs were obtained from Dutchland Laboratories, Inc. Denver, PA. They were housed individually in suspended stainless steel cages, with an equilibrium/acclimatization period of 23 days. They were fed Charles River Vitamin C-fortified guinea Pig Diet, ad libitum. Water was supplied ad libitum from the municipal water supply (Elizabethtown Water company. 12 hour light/12 hr dark schedule.
Males weighed between 323 and 432 grams, and females weighed between 316 and 401 grams when received on March 16, 1981. They were evaluated for health status before being randomly assigned to the dose groups. Each animals was identified with a monel ear tag bearing its unique animal number.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- 0.2 grams of test material moistened with 0.2 ml of paraffin oil
- Day(s)/duration:
- 9 inductions at 6 hours each, 3 inducitons/week.
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- Positive control DNCB was added to 80% ethanol (0.1% mixture)
- Day(s)/duration:
- 9 inductions over 3 weeks with challenge 14 days after last induction
- Adequacy of induction:
- highest technically applicable concentration used
Challenge
- No.:
- #20
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- 0.2 grams in 0.2 ml of vehicle
- Day(s)/duration:
- single challenge, 14 days after last induction
- Adequacy of challenge:
- other: limit concentration
- No. of animals per dose:
- 20 for test material, 12 for positive control, and 8 for irritation controls. For positive control substance iritation controls, the animals were shared with another study.
- Details on study design:
- On the day prior to the first application, the hair on the dorsal and lateral surfaces was clipped short with an electric clipper. 0.2 g of the test material was administered to each animal and moistened with 0.2 ml of paraffin oil, and control material mixtures were administered in a volume of 0.2 ml beneath a surgical guaze square, 1 inch by one inch, eight single layers thick, placed directly on the test site. The test site was the right side of the midline, as close to the midline as possible. The patch was covered by overlapping, inpermeable plastic. This was firmly secured by an elastic adhesive bandage which was wound around the torso of the animal. The patch was left in place for 6 hours after which it was removed and the skin was piped free of any excess material. This was repeated three times for a week for three weeks, for a total of nine insults.
Fourteen days after the last sensitization expousre, the challenge treatment was administered. Animals were clipped as before. the substances were administered in the same manner as the induction phase at a second site on the left side of the midline. After six hours of exposure, the patches were removed and the skin wiped free of any excess material.
Viability was checked twice daily. In life observations were preformed prior to treatment, and at 7, 14, 21, 28, and 35 days. Evaluation of the dermal responses were checked twice after challenge: at 24 hours and 48 hours after dosing. - Challenge controls:
- In order to differentiate dermal reactions produced by irritation from those produced by sensitization, eight animals (previously untreated) wer subjected to the same challenge procedures as the animals which received the nine sensitizing exposures.
- Positive control substance(s):
- yes
- Remarks:
- DNCB
Results and discussion
- Positive control results:
- The postivie control substance, DNCB, elicited a positve response in the study. Thus, sensitivity of the test method was concurrently demonstrated.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.2 g of 2,6-naphthalene dicarboxylic acid
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.2 g of 2,4-naphthalene dicarboxylic acid in paraffin oil
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under conditions of this study (9-induction Buehler), 2,6-naphthalene dicarboxylic acid exhibited little or no potential to produce dermal sensitization in guinea pigs.
- Executive summary:
In a nine induction Buehler assay, only two animals in the test substance treated group of 20 animals exhibited irritation scores of 1 after challenge. Scores of 2 or greater for erythema were considered to represent sensitization; scores of 1 (barely perceptible) were not considered to be definitive.
Animals treated with DNCB exhibited evidence of sensitization, thus confirming the susceptibility of this group of animals to sensitization.
Under conditions of this study, 2,6 -naphthalene dicarboxylic acid exhibited little or no potential to produce dermal sensitization in the guinea pigs.
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