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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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 19 June to 7 July 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- not specified
- Limit test:
- no
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 (IPA)
- Physical state: White powder
- Lot/batch No.: 10820-59-A
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Isophthalic acid (IPA)
- Physical state: White powder
- Lot/batch No.:10820-59-A
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories, Raleigh, NC
- Age at study initiation: Circa 41 and 60 days plus approximately two weeks for females and males respectively
- Weight at study initiation: Not stated
- Fasting period before study: Not stated
- Housing: The dams were housed in suspended polycarboate cages except during the exposure periods when they were transfered to stainless steel wire mesh inhalation cages.
- Diet (e.g. ad libitum): Purina Rodent Chow 5001 ad libitum
- Water (e.g. ad libitum): Purified water ad libitum
- Acclimation period: Not stated
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-25
- Humidity (%): Not stated
- Air changes (per hr): Air conditioned
- Photoperiod (hrs dark / hrs light): Fluorescent lighting was provided for 12 hours followed by 12 hours of darkness.
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- Isophthalic acid (IPA) was adminstered by inhalation. The test article aerosol was generated using dry materials. Ground IPA was placed into the feeder reservoir and moved to the bottom of the feeder by slow peristaltic action of the flexible, tapered walls of the feeder.
The aerosol entered through the top of the exposure chambers, via a venturi tube and was exhausted through a pipe located near the bottom of the chamber.
Exposures were conducted in 2 meter cubed stainless steel and glass chambers. Chamber air was filtered through high efficiency particle absorbing (HEPA) filters and controlled for temperature and humidity. Chamber air flow was maintained at 325 to 335 liters/min. - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- IPA concentrations were determined gravimetrically as well as by UV spectrophotometeric analysis. The exposure chambers were sampled at least twice during each exposure period.
- Details on mating procedure:
- - Impregnation procedure: Co-housed
- M/F ratio per cage: 2 female to 1 male
- Proof of pregnancy: Sperm in vaginal smear referred to as day 0 of pregnancy
- Any other deviations from standard protocol: Non-detailed. - Duration of treatment / exposure:
- The rats were exposed 6 hours per day, 7 days per week on gestation day 6 through 15, for a total of 10 consecutive exposures.
- Frequency of treatment:
- The rats were exposed 6 hours per day, 7 days per week on gestation day 6 through 15, for a total of 10 consecutive exposures.
- Duration of test:
- The rats were exposed 6 hours per day, 7 days per week on gestation day 6 through 15, for a total of 10 consecutive exposures.
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0.98 mg/m³ air
- Remarks:
- For 6h/day on Days 6-15 of gestation
- Dose / conc.:
- 4.23 mg/m³ air
- Remarks:
- For 6h/day on Days 6-15 of gestation
- Dose / conc.:
- 9.07 mg/m³ air
- Remarks:
- For 6h/day on Days 6-15 of gestation
- No. of animals per sex per dose:
- 25 timed-pregnant primiparous dams per dose.
- Control animals:
- yes, sham-exposed
- Details on study design:
- No further details
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Rats were observed for signs of toxicity approximately 0-3 hours following each exposure on gestation days 6 through 15, and daily thereafter.
- Cage side observations were included.
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Following treatment initiation, the rats were observed twice daily on weekdays and once daily on weekends for untoward affects of test article exposure.
BODY WEIGHT: Yes
- Time schedule for examinations: Day 0, 5, 6, 11, 16 and 20.
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day # 20
- Organs examined: The presence of lesions or abnormalities were described in the study record. the uterine horns of the dams with no observable implants were stained using a 10% ammonium sulfide solution to determine their pregnancy/resorption status.
- Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: Yes
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: No data
- Number of late resorptions: No data
- Other: - Fetal examinations:
- - External examinations: Yes, all the litter
- Soft tissue examinations: Yes, half per litter
- Skeletal examinations: Yes, half per litter
- Head examinations: Yes, half per litter - Statistics:
- Analysis of the log transformed litter body weights were conducted using analysis of variance (ANOVA). Log transformed dam body weights were analysed by multivariate analysis of variance for repeated measures.
- Indices:
- The statistical significance of an increased incidence of variations scored as 1 was not determined as such significant is usually meaningful only in the presence of anomalies of still greater severity or other direct indicators of teratogenic effects.
- Historical control data:
- Not relevant.
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Details on maternal toxic effects:
No toxic effects were observed.
Effect levels (maternal animals)
- Key result
- Dose descriptor:
- NOAEC
- Effect level:
- 9.07 mg/m³ air (analytical)
- Based on:
- test mat.
- Remarks on result:
- not determinable due to adverse toxic effects at highest dose / concentration tested
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
No toxic effects were observed.
Effect levels (fetuses)
- Key result
- Dose descriptor:
- NOAEC
- Effect level:
- 9.07 mg/m³ air
- Based on:
- test mat.
- Sex:
- male/female
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Fetal abnormalities
- Key result
- Abnormalities:
- no effects observed
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
Mean dam body weights and uterine weights (g) (mean ± standard deviation)
Dams/Group |
Study group |
|||
Filtered Air Control |
Isophthalic acid (mg/m³) |
|||
16 |
18 |
18 |
18 |
|
Gestation Day |
Mean Dam Body Weights |
|||
0 |
240 ± 20.0 |
237 ± 15.4 |
239 ± 11.4 |
240 ± 15.7 |
6 |
284 ± 20.6 |
282 ± 14.3 |
284 ± 15.0 |
283 ± 18.1 |
11 |
308 ± 21.2 |
301 ± 26.4 |
306 ± 22.1 |
307 ± 20.0 |
16 |
343 ± 26.1 |
336 ± 35.8 |
346 ± 27.4 |
340 ± 24.5 |
20 |
401 ± 40.7 |
394 ± 45.2 |
411 ± 49.0 |
399 ± 39.7 |
|
Mean Uterine Weights |
|||
66.4 ± 27.9 |
64.5 ± 30.3 |
77.8 ± 32.0 |
62.9 ± 27.1 |
|
Corrected Mean Full-Term Body Weightsa |
||||
334 ± 25.7 |
330 ± 26.4 |
334 ± 20.5 |
336 ± 21.2 |
a Corrected full-term body weight = full-term body weight minus uterine weight
Mean dam body weight gains (g) (mean ± standard deviation)
Dams/Group |
Study group |
|||
Filtered Air Control |
Isophthalic acid (mg/m³) |
|||
16 |
18 |
18 |
18 |
|
Gestation Day |
Mean Dam Body Weights |
|||
6-0 |
44 ± 6.6 |
45 ± 4.6 |
45 ± 6.8 |
43 ± 5.4 |
11-0 |
68 ± 7.0 |
64 ± 24.2 |
67 ± 17.0 |
67 ± 8.1 |
16-0 |
102 ± 15.0 |
99 ± 32.9 |
107 ± 21.1 |
100 ± 16.7 |
20-0 |
160 ± 33.4 |
157 ± 42.4 |
173 ± 43.3 |
159 ± 34.0 |
|
Mean Uterine Weights |
|||
66.4 ± 27.9 |
64.5 ± 30.3 |
77.8 ± 32.0 |
62.9 ± 27.1 |
|
Corrected Mean Full-Term Body Weightsa |
||||
94 ± 14.5 |
93 ± 22.1 |
95 ± 15.6 |
97 ± 11.6 |
a Corrected full-term body weight = full-term body weight minus uterine weight
Summary of gross external anomalies
Number Examined |
Study group |
|||
Filtered Air |
Isophthalic acid (mg/m³) |
|||
Control |
1 |
5 |
10 |
|
F(L)a |
F(L) |
F(L) |
F(L) |
|
185(15) |
201(17) |
242(16) |
192(17) |
|
Malformations: |
||||
HEAD Cleft Palate |
-(-)b |
2(1) |
-(-) |
-(-) |
Minor Observations: |
||||
HEAD |
|
|
|
|
Dome-Shaped |
-(-) |
3(2) |
-(-) |
-(-) |
Red Marks |
10(7) |
4(3) |
13(7) |
8(6) |
BODY Edematous |
-(-) |
2(2) |
-(-) |
-(-) |
a F(L) – Number of Fetuses (F), Number of Litters L
b -(-) = zero incidence
Applicant's summary and conclusion
- Conclusions:
- Inhalation exposure of pregnant rats to 0.98, 4.23 or 9.07 mg IPA/m³ during the major organogenesis period did not result in any significant toxic or teratogenic effects in the dam or fetus.
- Executive summary:
Groups of 25 mated female Sprague-Dawley rats were exposed (whole-body) to atmospheres containing isophthalic acid at concentrations of 0, 0.98, 4.23 or 9.07 mg/m³ for 6 hours/day on ten consecutive days (Day 6-15 of exposure). Dams were observed daily for clinical signs and bodyweights measured at regular intervals. Dams were sacrificed of gestation Day 20 and the uterine contents examined. Foetuses were assessed for external, skeletal and visceral findings.
No deaths occurred and no signs of toxicity were observed during the study period. Litter parameters were comparable in all groups and no treatment-related increase in the incidence of foetal findings was apparent. The maternal and developmental NOAEC for this study is therefore 9.07 mg/m³.
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