Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Currently viewing:

Administrative data

Endpoint:
sub-chronic toxicity: oral
Type of information:
other: Read across from another member of the category
Adequacy of study:
key study
Study period:
1968
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1969
Report date:
1969

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
Deviations:
yes
Remarks:
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:
no
Limit test:
no

Test material

Constituent 1
Reference substance name:
Sodium (xylenes and 4-ethylbenzene) sulfonates
EC Number:
701-037-1
Molecular formula:
-
IUPAC Name:
Sodium (xylenes and 4-ethylbenzene) sulfonates

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
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 data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24 degrees centigrade
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

Administration / exposure

Route of administration:
oral: feed
Vehicle:
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 temperature

VEHICLE
- 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 / concentrationsopen allclose all
Dose / conc.:
0 other: %
Dose / conc.:
0.2 other: %
Remarks:
Basis: nominal in diet
Dose / conc.:
1 other: %
Remarks:
Basis:nominal in diet
Dose / conc.:
5 other: %
Remarks:
Basis:nominal in diet
No. of animals per sex per dose:
15
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:
none

Examinations

Observations and examinations performed and frequency:
CAGE SIDE OBSERVATIONS:
- Observations: general appearance and behaviour
- Time schedule: no data

DETAILED CLINICAL OBSERVATIONS: No data

BODY WEIGHT:
Time schedule for examinations: weekly

FOOD 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: Compound intake calculated as time-weighted averages from the consumption and body weight

FOOD 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

WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study):
- Time schedule for examinations: weekly for the first week only

OPHTHALMOSCOPIC EXAMINATION: No

HAEMATOLOGY:
- 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:
- Time schedule for collection of blood: terminally
- Animals fasted: No data
- Number of aninals: 10 males and 10 females from each dose group
- Parameters checked

URINALYSIS:
- 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

NEUROBEHAVIOURAL EXAMINATION: No

OTHER EXAMINATIONS
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
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:
effects observed, treatment-related
Description (incidence and severity):
decreased red blood cells; decreased activity of a transaminase in serum
Clinical biochemistry findings:
no effects observed
Urinalysis findings:
effects observed, treatment-related
Description (incidence and severity):
decreased specific gravity of urine
Behaviour (functional findings):
not examined
Organ weight findings including organ / body weight ratios:
effects observed, treatment-related
Description (incidence and severity):
Decreased spleen weight
Gross pathological findings:
no effects observed
Histopathological findings: non-neoplastic:
effects observed, treatment-related
Description (incidence and severity):
Minimal changes in the liver
Histopathological findings: neoplastic:
not specified

Effect levels

open allclose all
Dose descriptor:
NOAEL
Effect level:
< 3 534 mg/kg bw/day (nominal)
Based on:
act. ingr.
Sex:
female
Basis for effect level:
other:
Remarks on result:
other: -
Dose descriptor:
NOAEL
Effect level:
> 763 mg/kg bw/day (nominal)
Based on:
act. ingr.
Sex:
male
Basis for effect level:
other:
Remarks on result:
other: -
Key result
Dose descriptor:
NOAEL
Effect level:
> 763 - < 3 534 mg/kg bw/day (actual dose received)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: see 'Remark'
Remarks on result:
other: -

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
NOAEL (male) > 3800 mg/kg bw /day corresponding to 3534 mg a.i./kg bw/day
NOAEL (female) = 820 mg/kg bw/day corresponding to 763 mg a.i./kg bw/day
Executive summary:

The repeated oral toxicity of Sodium (xylenes and 4-ethylbenzene) sulfonates was assessed following official guideline OECD 408, Repeated Dose 90-Day Oral Toxicity Study in Rodents. The tested substance showed a very low order of toxicity. No toxic effects were seen in the dose group that received 1% of the substance in the diet (corresponding to a daily intake of 763 mg a.i./kg bw). In the dose group treated with 5% of the substance in the diet (corresponding to 4092 mg a.i./kg bw) there were slight indications of deleterious effecs.