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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Repeated dose toxicity: oral

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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:
1990
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

Constituent 1
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

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