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EC number: 240-210-1 | CAS number: 16066-35-6
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- chronic toxicity: oral
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- supporting study
- Study period:
- 1990
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline and GLP study but without complete documentation available
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- p-toluenesulphonic acid
- IUPAC Name:
- p-toluenesulphonic acid
- Details on test material:
- - Name of test material (as cited in study report): p-toluene sulfonic acid
- Substance type: organic
- Physical state: monohydrate crystal
- Analytical purity: >98%
- Lot/batch No.: not indicated
- Storage condition of test material: not indicated
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Not available
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Details on oral exposure:
- Not available
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- one per day, 7 days per week
Doses / concentrations
- Remarks:
- Doses / Concentrations:
4, 20, 100 and 500 mg/kg bw/d
Basis:
actual ingested
- No. of animals per sex per dose:
- 10 or more
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- - Dose selection rationale: In a preliminary study to establish the doses for the definitive study, a single dose of 1250 mg.kg bw of the test substance resulted in 40% mortality of female rats. The definitive study high dose was set at 500 mg/kg bw/d
- Positive control:
- no
Examinations
- Observations and examinations performed and frequency:
- no details available
- Sacrifice and pathology:
- no details available
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- increased salivation in high dose males
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- increased salivation in high dose males
- Urinalysis findings:
- effects observed, treatment-related
- Description (incidence and severity):
- acidic urine in high dose males and females
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- >= 500 mg/kg bw/day (nominal)
- Based on:
- act. ingr.
- Sex:
- male/female
- Basis for effect level:
- other: see 'Remark'
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- NOAEL in the definitive study is 500 mg/kg bw/day.
A preliminary dose-finding study indicated mortality of females at 1250 mg/kg bw
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