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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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1990-03-28 to 1990-04-11
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Principles of method if other than guideline:
- Acute oral toxcity study in rats; limit test
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
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
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Isophthalic Acid
- Physical state: White Powder
- Lot/batch No.: 313B
- Storage condition of test material: Stored at room temperature approx. 22 °C
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Isophthalic Acid
- Physical state: White Powder
- Lot/batch No.: 313B
- Storage condition of test material: Stored at room temperature approx. 22 °C
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Male and female Sprague-Dawley rats, approximately 6 weeks of age were purchased from Charles River Breeding Laboratories (MI). They weighed 120-165 g on arrival. They were quarantined for at least 3 weeks and examined to ensure their health and suitability as test subjects. Individuals were identified by metal ear tags.
Purina Rodent Chow 5001 and reverse-osmosis purified water was supplied ad libitum (food was not available during the pre-dosing fasting period).
The rats were individually housed in suspended stainless steel cages. The animal rooms were maintained at approximately 22°C and 40% humidity. Fluorescent lighting was provided on a 12 hour light dark/cycle.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- Isophthalic acid was mixed thoroughly with reverse osmosis-purified water to form a 33 % (w/v) homogenous suspension which was stirred continuously while being administered at a dosing volume of 15 ml/kg of body weight, using a stainless steel ball-tipped needle.
Food was removed from the rat cages approximately 28 hours prior to dosing, and fasting was continued for approximately 4 hours after dosing. Dosage calculations were based on fasted bodyweights. - Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 5 male and 5 female rats
- Control animals:
- no
- Details on study design:
- Rats were randomly selected for testing.
The study animals were observed for signs of toxicity and mortality at approximately 1, 2, 3 and 4 hours after dosing, and at least once per day for the remainder of the 14-day observation period. Bodyweights were recorded prior to fasting, and immediately prior to dosing. All surviving rats were weighed on days 7 and 14.
The rats were euthanised with CO2 at the end of the observation period, and a limited gross necropsy was performed on all animals. - Statistics:
- A formal statistical analysis is not required
Results and discussion
- Preliminary study:
- No preliminary results available.
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No mortality at the limit dose
- Mortality:
- No deaths occurred during the study.
- Clinical signs:
- other: Signs observed within 24 hours following test article administration included irritability, salivation, redness around the nose, discolouration around the mouth, diarrhoea, wet and/or discoloured inguinal fur and discoloured paws. Most rats appeared norma
- Gross pathology:
- Gross necropsy findings were within normal limits in all rats.
- Other findings:
- No other findings reported.
Any other information on results incl. tables
Summary of clinical observations (5 rats/sex)
Observation |
Incidence |
|
Males |
Females |
|
Irritability |
0 |
1 |
Salivation |
1 |
0 |
Diarrhoeaa |
5 |
5 |
Redness around nose |
5 |
3 |
Discolouration around nose |
3 |
0 |
Wet inguinal fur |
2 |
0 |
Discoloured inguinal fur |
5 |
1 |
Discoloured paws |
2 |
0 |
a – or evidence of dried diarrhoea below cage
Summary of mean body weights
Time point |
Mean body weight (g) ± SD |
|
Males |
Females |
|
Initial (non-fasted) |
357 ± 26.9 |
208 ± 12.0 |
Initial (fasted) |
322 ± 24.9 |
185 ± 12.6 |
Day 7 |
370 ± 18.2 |
211 ± 10.8 |
Day 14 |
400 ± 16.4 |
217 ± 10.8 |
Weight change (g) |
43 |
9 |
*SD = Standard Deviation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of this study, the median acute lethal oral dose (LD50) of isophthalic acid was estimated to be greater than 5000 mg/kg of body weight in male and female rats.
- Executive summary:
The acute oral toxicity of isophthalic acid was evaluated in 5 male and 5 female Sprague-Dawley rats. The test substance was administered as a homogenous suspension in water, by gavage, at a single limit dose of 5000 mg/kg bw. Rats were fasted prior to dosing, and dose calculations were based on fasted body weights. Rats were observed for 14 days after dosing, and subject to gross necropsy at study termination. All rats survived to the end of the study. Clinical signs observed within 24 hours following test article administration included irritability, salivation, redness around the nose, discolouration around the mouth, diarrhoea, wet and/or discoloured inguinal fur and discoloured paws. Most rats appeared normal 48 hours following administration. There were no abnormalities detected at necropsy. The acute oral LD50 of isophthalic acid was therefore estimated to be greater than 5000 mg/kg bw in male and female rats under the conditions of this study.
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