Benzenesulfonic acid, 4-(1-methylethyl)-, ammonium salt (1:1)

Repeated dose toxicity: oral

Administrative data

Endpoint:

sub-chronic toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

June - September 1983

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Remarks:

The animal had Sialodacryadenitis due to viral infection

Justification for type of information:

please see Category approach

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)

GLP compliance:

no

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Sodium p-cumenesulphonate

EC Number:

239-854-6

EC Name:

Sodium p-cumenesulphonate

Cas Number:

15763-76-5

Molecular formula:

C9H12O3S.Na

IUPAC Name:

sodium 4-isopropylbenzenesulfonate

Details on test material:

Purity: 40.2 % (aqueous solution)

Test animals

Species:

rat

Strain:

Wistar

Remarks:

Bor: WISW (SPF TNO)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Fa. Winkelmann, 4799 Borchen
no further details mentioned

Administration / exposure

Route of administration:

oral: drinking water

Vehicle:

unchanged (no vehicle)

Analytical verification of doses or concentrations:

no

Duration of treatment / exposure:

13 weeks / 90 days

Frequency of treatment:

daily (7 days/week)

Doses / concentrations

Doses / concentrations 1

Dose / conc.:

400 mg/kg bw/day (nominal)

Doses / concentrations 2

Dose / conc.:

800 mg/kg bw/day (nominal)

Doses / concentrations 3

Dose / conc.:

1 200 mg/kg bw/day (nominal)

No. of animals per sex per dose:

10, additionally 10 for recovery (control and high dose group)

Control animals:

yes

Details on study design:

- Dose selection rationale: previous range finding test
3 weeks, 3 dosages (400; 800; 1200 mg/kg bw/d) and 1 control, every group with 5 w, 5 m
2 different tests a) drinking water b) food
no substance specific effects (body weight gain, pathological, histopathological effects, clinical signs, behaviour)

Positive control:

none

Examinations

Observations and examinations performed and frequency:

CAGE SIDE OBSERVATIONS: Yes
- Observations: general appearance and behaviour
- Time schedule: a few times/day


DETAILED CLINICAL OBSERVATIONS: a few times/day


BODY WEIGHT: Yes
- Time schedule for examinations: weekly


FOOD CONSUMPTION: Yes
- Time schedule for examinations: weekly


WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Yes
- Time schedule for examinations: weekly


OPHTHALMOSCOPIC EXAMINATION: all anminals, before application, weeks 6-7, 12-13, recovery group (17 = 4 weeks later)


HAEMATOLOGY: Yes
- Time schedule for collection of blood: weeks 6-7, 12-13 and recovery group (17 = 4 weeks later)
- Anaesthetic used for blood collection: ether
- Animals fasted: no
- How many animals: all
- Parameters: WBC, RBC, Hb, Hct, MCH, MCV, MCHC, thrombocytes, differential hemogram, number of reticulocytes


CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: weeks 6-7, 12-13, recovery group (17 = 4 weeks later)
- Animals fasted: no
- How many animals: all
- Parameters: glucose, kreatinine, urea, total bilirubin, proteine, chloride, phosphate, GOT, GPT, gamm-GT, cholesterine, triglyceride, Na, K


URINALYSIS: Yes
- Time schedule for collection of urine: urinalysis from pooled samples (6 hours)
- Metabolism cages used for collection of urine: yes
- Animals fasted: no data
- Parameters checked: pH, glucose, ketone, urobilinogene, proteine, blood, specific density, native sediment with microscope


NEUROBEHAVIOURAL EXAMINATION: Not mentioned

Sacrifice and pathology:

GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes

Results and discussion

Results of examinations

Clinical signs:

no effects observed

Mortality:

no mortality observed

Body weight and weight changes:

no effects observed

Food consumption and compound intake (if feeding study):

no effects observed

Food efficiency:

no effects observed

Water consumption and compound intake (if drinking water study):

no effects observed

Ophthalmological findings:

not examined

Haematological findings:

no effects observed

Clinical biochemistry findings:

no effects observed

Urinalysis findings:

no effects observed

Behaviour (functional findings):

no effects observed

Organ weight findings including organ / body weight ratios:

no effects observed

Gross pathological findings:

no effects observed

Histopathological findings: non-neoplastic:

no effects observed

Histopathological findings: neoplastic:

not specified

Effect levels

Key result

Dose descriptor:

NOAEL

Effect level:

1 200 mg/kg bw/day (actual dose received)

Based on:

act. ingr.

Sex:

male/female

Basis for effect level:

clinical signs

mortality

Target system / organ toxicity

Critical effects observed:

no

Applicant's summary and conclusion

Conclusions:

The test compound sodium cumenesulphonate possesses a very low order of toxicity. Including the highest dose group no substance specific adverse effects could be found (NOAEL = 1200 mg/kg/d).

Executive summary:

Test compound sodium cumenesulphonate possesses a very low order of toxicity. Including the highest dose group no substance specific adverse effects could be found (NOAEL = 1200 mg/kg/d).