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Diss Factsheets
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EC number: 202-774-7 | CAS number: 99-63-8
- 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
![](https://poisoncentres.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: This study was selected as the key study because the information provided for the hazard endpoint is sufficient for the purpose of classification and labeling and/or risk assessment.
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)
- Deviations:
- no
- Remarks:
- The study was conducted according to the guideline in effect at the time of study conduct.
- GLP compliance:
- yes
- 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:
- benzene-1,3-dicarboxylic acid
- Details on test material:
- - Purity: no data
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: females - 41 days; males - 60 days
- Weight at study initiation: not reported
- Fasting period before study: not reported
- Housing: The dams were housed in suspended polycarbonate cages except during the exposure periods when they were transferred to stainless steel wire mesh inhalation cages.
- Diet: Purina Rodent Chow 5001 ad libitum
- Water: Purified water ad libitum
- Acclimation period: not reported
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-25 °C
- Humidity (%): not reported
- 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
- Type of inhalation exposure (if applicable):
- whole body
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
The test substance was administered by inhalation. The test article aerosol was generated using dry materials. Ground test substance 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:
- Method of Analysis:
The test substance concentrations were determined gravimetrically as well as by UV spectrophotometric analysis. The exposure chambers were sampled at least twice during each exposure period. - Details on mating procedure:
- - Impregnation procedure: cohoused
- If cohoused:
- 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
- Remarks:
- Doses / Concentrations:
0, 1.0, 5.0 and 10.0 mg/m³
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
0, 0.98, 4.23, 9.07 mg/m³
Basis:
analytical conc.
- 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 effects 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 was 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 - Fetal examinations:
- - External examinations: Yes: all per litter
- Soft tissue examinations: Yes: half per litter
- Skeletal examinations: Yes: half per litter
- Head examinations: Yes: [all per litter 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.
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)
open allclose all
- Dose descriptor:
- NOAEC
- Effect level:
- 9.07 mg/m³ air (analytical)
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOAEC
- Effect level:
- 9.07 mg/m³ air (analytical)
- Based on:
- test mat.
- Basis for effect level:
- other: developmental toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
No toxic effects were observed.
Fetal abnormalities
- Abnormalities:
- not specified
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) |
||||||||||
|
Control |
Test substance (mg/m³) |
||||||||
Dams/Group |
16 |
18 |
18 |
18 |
||||||
Gestation Day |
|
1.0 mg/m³ |
5.0 mg/m³ |
10.0 mg/m³ |
||||||
|
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 |
||||||
|
Mean dam body weight gains (g) (mean ± standard deviation) |
||||
|
Control |
Test substance (mg/m³) |
||
Dams/Group |
16 |
18 |
18 |
18 |
Gestation Day |
|
1.0 mg/m³ |
5.0 mg/m³ |
10.0 mg/m³ |
|
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 ± 6.7 |
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 |
Number Examined |
Study group |
|||
Filtered Air |
Test substance (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 |
-(-)b |
2(1) |
-(-) |
-(-) |
Cleft Palate |
||||
Minor Observations: |
||||
HEAD |
|
|
|
|
Dome-Shaped |
-(-) |
3(2) |
-(-) |
-(-) |
Red Marks |
10(7) |
4(3) |
13(7) |
8(6) |
BODY |
-(-) |
2(2) |
-(-) |
-(-) |
Edematous |
||||
a F(L) – Number of Fetuses (F), Number of Litters L |
Applicant's summary and conclusion
- Conclusions:
- This study and the conclusions which are drawn from it fulfill the quality criteria (validity, reliability, repeatability).
Inhalation exposure of pregnant rats to 0.98, 4.23 or 9.07 mg/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 the test substance at measured 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. Fetuses 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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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