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Toxicological information

Repeated dose toxicity: oral

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Administrative data

Endpoint:
chronic toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1990
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents)
Deviations:
no
GLP compliance:
yes
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
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

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals 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