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EC number: 204-506-4 | CAS number: 121-91-5
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1984-11-05 to 1984-11-19
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Proprietary study: equivalent to OECD guideline 405.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Isophthalic acid
- EC Number:
- 204-506-4
- EC Name:
- Isophthalic acid
- Cas Number:
- 121-91-5
- Molecular formula:
- C8H6O4
- IUPAC Name:
- isophthalic acid
- Details on test material:
- - Name of test material (as cited in study report): IPA-99
- Physical state: White Powder
- Storage condition of test material: Stored at room temperature at approxiametely 22 °C
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
New Zealand albino rabbits were purchased from Hazleton Dutchland Laboratories for use in this study. Upon arrival (10/23/1984), the rabbits were held in quarantine for approximately two weeks and examined carefully to ensure their health and suitability as test subjects. Rabbits selected for the study were identified by a unique numbered metal tag inserted through the pinna of the right ear and by a cage number. Purina Lab Rabbit Chow HF #5326 and water supplied from a reverse osmosis purifier by an automatic watering system were available ad libitum. The rabbits were housed individually in stainless steel cages measuring 61.0 x 45.5 x 41.0 cm. Poly pads were placed in the pan below the stainless steel mesh floor of each animal cage to adsorb liquids.
ENVIRONMENTAL CONDITIONS
Air conditioned animal rooms were maintained at approximately 22 °C and 40 % relative humidity. Fluorescent lighting was provided for 12 hours followed by 12 hours of darkness.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
0.1 g of the undiluted test article was placed into the everted lower lid of the right eye of each rabbit. The lids were held closed for approximately two seconds following test article administration. The other eye was left untreated.
VEHICLE
No vehicle used - Duration of treatment / exposure:
- IPA-99 was placed into the everted lower lid of the right eye of each rabbit. The lids were held closed for approximately two seconds following test article administration.
- Observation period (in vivo):
- 14 days
- Number of animals or in vitro replicates:
- 3 males and 3 females
- Details on study design:
- Rabbits used on test were selected at random and assigned to a single group of three males and three females.
The treated eye of each rabbit was scored for irritation at 1, 2, 3, 4, 7 and 14 days following test article administration. The right eye remained untreated and was used for control comparison.
The eyes were examined and scored by the method of Draize (Draize, J.H., Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, Assoc. Food & drug Officials of the U.S., Austin TX, 1959). A rabbit was considered to exhibit a positive reaction if, at any observation period, the test article produced ulceration or opacity of the cornea (any cornea score greater than 0), inflammation or slight circumcorneal injection of blood vessels of the iris (any iris score greater than 0), any obvious conjunctival swelling with partial eversion of the lids (a chemosis score of 2 or greater) with individual vessels not easily discernable (“methods of Testing Primary Irritant Substances”, - Federal Register, 38, No. 187, p.27019, September 1973).
After the final observation, the rabbits were sacrificed, necropsies were not performed.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24-72h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: No reactions
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24-72h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: No reactions
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24-72h
- Score:
- 0.72
- Max. score:
- 2
- Reversibility:
- fully reversible within: 96h
- Remarks on result:
- other: Erythema
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24-72h
- Score:
- 0.67
- Max. score:
- 2
- Reversibility:
- fully reversible within: 96h
- Irritant / corrosive response data:
- No irritation of the cornea or iris was observed in any rabbit during the study. Conjunctival irritation (i.e. erythema, chemosis and/or discharge) was observed in all rabbits 1 day following test article administration. Complete recovery from these signs of ocular irritation was evident in two rabbits by the 2nd day, in five rabbits by the 4th day, and in all rabbits by the final scoring evaluation.
- Other effects:
- None
Any other information on results incl. tables
Eye irritation scores:
Observation |
24h |
48h |
72h |
Mean (24-72h) |
96h |
7d |
14d |
|
Cornea |
Opacity |
0,0,0,0,0,0 |
0,0,0,0,0,0 |
0,0,0,0,0,0 |
0.00 |
0,0,0,0,0,0 |
0,0,0,0,0,0 |
0,0,0,0,0,0 |
Iris |
Lesion |
0,0,0,0,0,0 |
0,0,0,0,0,0 |
0,0,0,0,0,0 |
0.00 |
0,0,0,0,0,0 |
0,0,0,0,0,0 |
0,0,0,0,0,0 |
Conjunctivae |
Erythema |
1,1,1,1,2,2 |
1,0,0,0,1,1 |
0,0,0,1,1,0 |
0.72 |
0,0,0,0,0,0 |
1,0,0,0,0,0 |
0,0,0,0,0,0 |
Chemosis |
2,1,1,0,2,1 |
1,0,1,0,0,1 |
0,0,0,0,1,1 |
0.67 |
0,0,0,0,0,1 |
0,0,0,0,0,0 |
0,0,0,0,0,0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Isophthalic acid (IPA) was administered undiluted into one eye of each of six rabbits. Ocular irritation was seen in all rabbits during the study, but only three rabbits exhibited positive reactions. Complete recovery from all signs of ocular irritation was evident in two rabbits by the 2nd day, in five rabbits by the 4th day, and in all rabbits by the final scoring interval. Therefore, IPA was not considered to be irritating.
- Executive summary:
Isophthalic acid (IPA) was administered undiluted at a dose of 0.1 g into one eye of each of six rabbits, with the other eye serving as an untreated control. The treated eye of each rabbit was scored for irritation at 1, 2, 3, 4, 7 and 14 days following test article administration. The control eye was used for comparison. The maximum irritation score of 5.3/110.0 was obtained 1 day after administration of the test article. Ocular irritation was seen in all rabbits during the study. Complete recovery from all signs of ocular irritation was evident in two rabbits by the 2nd day, in five rabbits by the 4th day, and in all rabbits by the final scoring interval.
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