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EC number: 202-830-0 | CAS number: 100-21-0
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
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- Endpoint summary
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- Environmental data
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- 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
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- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
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- 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

Toxicity to reproduction: other studies
Administrative data
- Endpoint:
- toxicity to reproduction: other studies
- Type of information:
- experimental study
- Adequacy of study:
- disregarded due to major methodological deficiencies
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The findings of this study are considered to be valid; however the nature of the test material (a complex mixture of substances including terephthalic acid) is such that the findings cannot be attributed to TPA or any individual component.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Assessment of the effects of manufacturing wastewater on the reproductive tract of male mice following repeated oral exposure.
- GLP compliance:
- no
- Type of method:
- in vivo
Test material
- Reference substance name:
- Purified terepthalic acid wastewater: a complex mixture of organic and inorganic components, including 444 mg/L TPA
- IUPAC Name:
- Purified terepthalic acid wastewater: a complex mixture of organic and inorganic components, including 444 mg/L TPA
- Test material form:
- other: liquid
- Details on test material:
- The test material (wastewater) was collected from a petrochemical wastewater treatment plant. The wastewater was characterised by GC/MS for organic compounds and by ICP for metal ions. Components are stated to be:COD 9072 mg/LBOD 4086 mg/LpH 6.2Total N 52 mg/LTotal P 9 mg/LTSS 440 mg/LTerephthalic acid 444 mg/Lp-Toluic acid 332 mg/LBenzoic acid 227 mg/LPhthalic acid 325 mg/Lp-Carbooxybenzaldehyde 18 mg/LCa 38 mg/LCu <0.002 mg/LMn 11 mg/LPb 0.44 mg/LZn 0.02 mg/L
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- other: KM
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Source: Qinglong Hill Experimental Animal Centre, Nanjing, China- Age at study initiation: no data- Weight at study initiation: 18-22 g- Fasting period before study: no data- Housing: individual- Diet: ad libitum- Water: ad libitum- Acclimation period: 7 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 20-24- Humidity (%): 45-55- Air changes (per hr): no data- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- Male mice were administered wastewater or PBS (0.2 mL/day) on 35 consecutive days
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The test material (wastewater) was collected from a petrochemical wastewater treatment plant. The wastewater was characterised by GC/MS for organic compounds and by ICP for metal ions.
- Duration of treatment / exposure:
- 35 days
- Frequency of treatment:
- Daily
- Duration of test:
- 36 days
Doses / concentrations
- Remarks:
- Doses / Concentrations:2 mL/dayBasis:actual ingested
- No. of animals per sex per dose:
- 12 males
- Control animals:
- yes
- Details on study design:
- Male mice were administered wastewater or PBS (0.2 mL/day) on 35 consecutive days; mice were sacrificed on Day 36.
- Statistics:
- Results were analysed using the independent samples t-test (p<0.05)
Results and discussion
Observed effects
Any other information on results incl. tables
| Controls | Wastewater treated |
Initial bodyweight (g) | 26.46 | 26.46 |
Final bodyweight (g) | 29.09 | 34.42 |
Relative liver weight | 5.52% | 4.83%** |
Relative testes weight | 0.74% | 0.66%* |
Spermatogenic cells | ||
1C | 66.9 | 68.9 |
2C | 20.7 | 19.5* |
SC | 7.5 | 2.2** |
4C | 3.6 | 7.7** |
1C:4C | 19.3 | 9.0** |
1C:2C | 3.2 | 3.5* |
4C:2C | 0.17 | 0.39** |
4C:SC | 0.48 | 3.5** |
Abnormal sperm | 3.09% | 6.22%* |
Viable spermatogenic cells | 93.1% | 90.4%* |
*significantly different to controsl (p<0.05) **p<0.01
Applicant's summary and conclusion
- Conclusions:
- The results of this study indicate that the wastewater caused effects on the testes of male mice; however due to the complex nature of the material tested, the contribution of terephthalic acid to the observed effects is unknown.
- Executive summary:
Groups of 10 male KM mice were administered 0.2 mL petrochemical plant wastewater containing terephthalic acid (444 mg/L) and numerous other components. Based on the TPA content of the test material and the average bodyweight of the treated mice, TPA intake is calculated to be approximately 3 mg/kg bw/d. Bodyweights were recorded on Day 1 and Day 35. Weights of the heart, liver, lungs, spleen, kidney and testes were recorded and relative organ weights calculated. Spermatogenic cells were isolated from the testes, stained with propdidum iodide and analysed using flow cytometry. The relative proportions of haploid, diploid, S-phase and tetraploid cells were calculated based on staining intensity. Cell viability was assessed based on the measurement of intracellular lipase activity and plasma membrane integrity. Epididymal sperm were assessed morpholoogically. The testes were assessed histopathologically following fixation in Bouin's. No deaths occurred. Final bodyweights of treated mice were 18% higher than controls; the difference was not statistically significant. Relative liver and testes weights were significantly lower than controls (12.4% and 10,6%, respectively); however these values may be seondary to bodyweight effects. Flow cytometry showed reductions in the proportions of 2C and SC cells and a reduced 1C:4C ratio. 1C:2C, 4C:2C and 4C:SC cell ratios were significantly increased in the treated group. Samples from the treated group were shown to have a significantly higher proportion of abnormal sperm including folded tail, absent head and folded neck. The proportion of viable spermatogenic cells was slightly (but significantly) reduced in the treated group. Testicular histopathology of treated mice revealed an expanded interstitial space, reduced Leydig cell size and reduced numbers of sperm.
The results of this study indicate that the wastewater caused effects on the testes of male mice; however due to the complex nature of the material tested, the contribution of terephthalic acid to the observed effects is unknown. Comparing the results of this study to the wider dataset, it would seem to be extremely unlikely that the dose level of TPA achieved in this study (~3 mg/kg bw) is responsible for the effects observed.
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