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Toxicological information

Repeated dose toxicity: oral

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Administrative data

sub-chronic toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline not specified, but with detailed documentation

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guideline
equivalent or similar to guideline
OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
no functional observations or ophthalmoscopy
Principles of method if other than guideline:
Groups of 30 young rats (15 males and 15 females) were exposed by diet for 90 days to three concentrations. A control group was included. Observations were made of behavior, appearance, growth, food and water intake and a number of haematological factors. At the end of the experiment (during week 14) ten organs of each surviving rat were weighed and examined histologically for pathological changes. Liver enxyme activities were also determined.
GLP compliance:
not specified
Limit test:

Test material

Constituent 1
Reference substance name:
sodium xylene sulphonate
sodium xylene sulphonate
Details on test material:
- Name of test material (as cited in study report): sodium xylene sulphonate; Halvopon OR- Substance type: - Physical state: fine, white, odorless powder- Analytical purity: described as "purified" sodium xylene sulphonate; infrared spectrum of the sample is in the report; 93% active ingredient- Impurities (identity and concentrations): no data- Composition of test material, percentage of components: infrared spectrum of the sample is in the report- Purity test date: 93% active ingredient- Lot/batch No.: no data- Expiration date of the lot/batch: no data- Stability under test conditions: no data- Storage condition of test material: no data- Other:

Test animals

Details on test animals or test system and environmental conditions:
TEST ANIMALS- Source: CIVO-colony- Age at study initiation: newly weaned - Weight at study initiation: 41-60 g- Fasting period before study: no data- Housing: metal wire screen cages (5 to a cage)- Diet (e.g. ad libitum): ad libitum- Water (e.g. ad libitum): ad libitum- Acclimation period: no dataENVIRONMENTAL CONDITIONS- Temperature (°C): 24 degrees centigrade- Humidity (%): no data- Air changes (per hr): no data - Photoperiod (hrs dark / hrs light): no dataIN-LIFE DATES: From: To: no data

Administration / exposure

Route of administration:
oral: feed
unchanged (no vehicle)
Details on oral exposure:
PREPARATION OF DOSING SOLUTIONS: test chemical mixed directly with stock diet DIET PREPARATION- Rate of preparation of diet (frequency): once a fortnight- Mixing appropriate amounts with (Type of food): stock diet consisting of 28% yellow maize, 26% whole wheat, 10% rolled oats, 10% soybean oil meal, 8% fish meal and <5% each of meat scraps, dried whey, soybean oil, grass meal, minerals, sodium chloride and vitamin preparation.- Storage temperature of food: room temperatureVEHICLE- Justification for use and choice of vehicle (if other than water): no vehicle
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
13 weeks / 90 days
Frequency of treatment:
in ad libitum diet
Doses / concentrations
Doses / Concentrations:0.2%, 1.0% and 5.0%Basis:nominal in diet
No. of animals per sex per dose:
Control animals:
yes, concurrent no treatment
Details on study design:
- Dose selection rationale: previous range finding test- Rationale for animal assignment (if not random): according to body weight
Positive control:


Observations and examinations performed and frequency:
CAGE SIDE OBSERVATIONS: Yes- Observations: general appearance and behaviour- Time schedule: no dataDETAILED CLINICAL OBSERVATIONS: No dataBODY WEIGHT: Yes- Time schedule for examinations: weeklyFOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): - Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes - Compound intake calculated as time-weighted averages from the consumption and body weight gain data: NoFOOD EFFICIENCY:- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: YesWATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Yes - Time schedule for examinations: weekly for the first week onlyOPHTHALMOSCOPIC EXAMINATION: NoHAEMATOLOGY: Yes- Time schedule for collection of blood: week 6 and week 12- Anaesthetic used for blood collection: No data- Animals fasted: No- How many animals: 10 males and 10 females from each dose group- Parameters checked in table [No.4] were examined.CLINICAL CHEMISTRY: Yes- Time schedule for collection of blood: terminally- Animals fasted: No data- How many animals: 10 males and 10 females from each dose group- Parameters checked in table [No.5 and No.6] were examined.URINALYSIS: Yes - Time schedule for collection of urine: urinalysis from pooled samples from 10 males and 10 females from each dose group in 7th week.- Metabolism cages used for collection of urine: No data- Animals fasted: No data- Parameters checked in table [No.7 and No.8] were examined.NEUROBEHAVIOURAL EXAMINATION: NoOTHER: kidney funcion from samples of 10 males and 10 females in 13th week. Serum protein electrophoresis of 10 males and 10 females of control and high dose groups at 13 weeks. Liver enzyme activity at termination.
Sacrifice and pathology:
GROSS PATHOLOGY: Yes (see table No.10) HISTOPATHOLOGY: Yes (see table No.11)

Results and discussion

Results of examinations

Clinical signs:
no effects observed
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:
effects observed, treatment-related
Clinical biochemistry findings:
no effects observed
Urinalysis findings:
effects observed, treatment-related
Behaviour (functional findings):
not examined
Organ weight findings including organ / body weight ratios:
effects observed, treatment-related
Gross pathological findings:
no effects observed
Histopathological findings: non-neoplastic:
effects observed, treatment-related
Histopathological findings: neoplastic:
not specified

Effect levels

Key result
Dose descriptor:
Effect level:
> 763 - < 3 534 mg/kg bw/day (actual dose received)
Basis for effect level:
other: see 'Remark'

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Test compound possesses a very low order of toxicity. 1% in the diet (corrresponding to a daily intake of 763 mg a.i./kg bw) was a no toxic effect level. At 5% in the diet (corresponding to 4092 mg a.i./kg bw) there were slight indications of deleterious effecs.