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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
Data is from peer-reviewed journal

Data source

Reference
Reference Type:
publication
Title:
Subacute oral toxicity of a biodegradable, linear alkylbenzene sulfonate
Author:
J.H.Kay
Year:
1965
Bibliographic source:
Toxicology and Applied Pharmacology

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
The subchronic repeated dose toxicity study of in rats was conducted to evaluate the adverse effects by oral route.
GLP compliance:
not specified
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium dodecylbenzenesulfonate
EC Number:
246-680-4
EC Name:
Sodium dodecylbenzenesulfonate
Cas Number:
25155-30-0
Molecular formula:
C18H30O3S.Na
IUPAC Name:
Sodium dodecylbenzenesulfonate
Details on test material:
- Name of test material (as cited in study report): Sodium Dodecylbenzenesulfonate (SDDBS)
- Molecular formula:C18H29NaO3S
- Molecular weight:348.48 g/mole
- Substance type:Organic

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
oral: feed
Vehicle:
other: commercial chow
Details on oral exposure:
PREPARATION OF DOSING SOLUTIONS: No data available

DIET PREPARATION
- Rate of preparation of diet (frequency): No data available
- Mixing appropriate amounts with (Type of food): No data available
- Storage temperature of food: No data available

VEHICLE
- Justification for use and choice of vehicle (if other than water): commercial chow
- Concentration in vehicle: 0, 0.02%, 0.1%, and 0.5% (equivalent to 0, 8.8, 44, 220 mg/kg bw/day )
- Amount of vehicle (if gavage): No data available
- Lot/batch no. (if required): No data available
- Purity: No data available
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
90 days
Doses / concentrationsopen allclose all
Dose / conc.:
0 other: mg/kg bw/day
Remarks:
0%
Dose / conc.:
8.8 other: mg/kg bw/day
Remarks:
(eqivalent to 0.02%)
Dose / conc.:
44 other: mg/kg bw/day
Remarks:
(eqivalent to 0.1%)
Dose / conc.:
220 other: mg/kg bw/day
Remarks:
(eqivalent to 0.5%)
No. of animals per sex per dose:
0.0 mg/kg bw/day :10 males and 10 females
8.8 mg/kg bw/day :10 males and 10 females
44.0 mg/kg bw/day :10 males and 10 females
220.0 mg/kg bw/day :10 males and 10 females
Control animals:
yes
Positive control:
No data available

Examinations

Observations and examinations performed and frequency:
CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Not specified
- Cage side observations checked in table [No.?] were included: Mortality was observed.

DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Not specified

BODY WEIGHT: Yes
- Time schedule for examinations: Recorded weekly

FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes
- Food consumption measurements were conducted during the entire test period and calculated weekly.
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Not specified
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Not specified

FOOD EFFICIENCY: Not specified
- 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: Not specified

WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Not specified
- Time schedule for examinations: Not specified

OPHTHALMOSCOPIC EXAMINATION: Not specified
- Time schedule for examinations: Not specified
- Dose groups that were examined: Not specified

HAEMATOLOGY: Yes
- Time schedule for collection of blood: Blood studies were conducted at the beginning of the test and after 30, 60, and 90 days of testing.
- Anaesthetic used for blood collection: Not specified
- Animals fasted: Not specified
- How many animals: 5 males and 5 females
- Parameters checked in table [No.?] were examined.: Blood studies, including determinations of hemoglobin concentration, erythrocyte count, hematocrit value, and total and differential leukocyte counts were conducted.

CLINICAL CHEMISTRY: Not specified
- Time schedule for collection of blood: Not specified
- Animals fasted: Not specified
- How many animals: Not specified
- Parameters checked in table [No.?] were examined.: Not specified

URINALYSIS: Yes
- Time schedule for collection of urine: Urine analysis were conducted at the beginning of the test and after 30, 60, and 90 days of testing.
- Metabolism cages used for collection of urine: Not specified
- Animals fasted: Not specified
- How many animals: 5 males and 5 females
- Parameters checked in table [No.?] were examined.: Not specified

NEUROBEHAVIOURAL EXAMINATION: Not specified
- Time schedule for examinations: Not specified
- Dose groups that were examined: Not specified
- Battery of functions tested: sensory activity / grip strength / motor activity / other: Not specified

IMMUNOLOGY: Not specified
- Time schedule for examinations: Not specified
- How many animals: Not specified
- Dose groups that were examined: Not specified
- Parameters checked in table [No.?] were examined.: Not specified

OTHER:Not specified
Sacrifice and pathology:
At the end of the test period all animals were sacrificed by either inhalation, and each was subjected to complete autopsy.
GROSS PATHOLOGY: Yes
The body weight at autopsy was recorded along with the weights of the liver, kidneys, spleen, gonads, heart and brain.

HISTOPATHOLOGY: Yes
Complete microscopic examinations were conducted. The following tissues and organs were studied: heart, liver, lung, pancreas, stomach (cardia, fundus, pylorus), small intestine (duodenum, ileum and jejunum), colon, spleen, lymph node, kidney, urinary bladder, testis or ovary, prostate or uterus, pituitary, adrenal, thyroid, parathyroid, skeletal muscle, bone marrow, and brain (cerebellum, cerebrum, and pons).
Other examinations:
No data available
Statistics:
Bartlett (1973) tests for homogeneity of variance were conducted on these data followed by an analysis of variance. Significant effects for treatments disclosed by the analysis of variance were further studied by the t- test. Data showing heterogeneity of variance were treated directly by the t-test, in which no assumption of homogeneity of variance was required.

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Description (incidence and severity):
No abnormal reactions were noted.
Mortality:
no mortality observed
Description (incidence):
Two males at the 0.02% dietary level died in the early stages of the study. These deaths were attributed to respiratory illness, not to ingestion of the test material.
Body weight and weight changes:
no effects observed
Description (incidence and severity):
No statistically significant effects for treatments were disclosed.
Food consumption and compound intake (if feeding study):
no effects observed
Description (incidence and severity):
Findings of test and control groups were comparable.
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
no effects observed
Description (incidence and severity):
No abnormalities resulted from ingestion of the test substance.
Clinical biochemistry findings:
not specified
Urinalysis findings:
no effects observed
Description (incidence and severity):
The results of urine analyses revealed no significant differences between test animals and control animals respecting the presence of reducing substances, protein, and microscopic elements.
Behaviour (functional findings):
not specified
Immunological findings:
not specified
Organ weight findings including organ / body weight ratios:
no effects observed
Description (incidence and severity):
Statistical analyses of organ:body weight and organ:brain weight ratios indicated there were no significant differences related to ingestion of the test substance.
Gross pathological findings:
no effects observed
Description (incidence and severity):
There were no gross pathologic findings which could be correlated with the ingestion of the test material.
Neuropathological findings:
not specified
Histopathological findings: non-neoplastic:
no effects observed
Histopathological findings: neoplastic:
not specified
Other effects:
not specified

Effect levels

Dose descriptor:
NOAEL
Effect level:
220 other: mg/kg bw/day
Based on:
test mat.
Sex:
male/female
Basis for effect level:
body weight and weight gain
clinical signs
food consumption and compound intake
gross pathology
haematology
histopathology: non-neoplastic
mortality
organ weights and organ / body weight ratios
urinalysis
other: No effects were observed.
Remarks on result:
other: No toxic effect were observed

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
The NOAEL was considered to be 220.0 mg/kg body weight /day when Sprague-Dawley rats were treated wtih test substance .
Executive summary:

The subchronic repeated dose toxicity study of test substance in rats was conducted to evaluate the adverse effects by oral route. Test substance was fed to rats at dietary levels of 0.02%, 0.1%, and 0.5% (equivalent to 8.8, 44, 220 mg/kg bw/day ) for 90 days. No adverse effects were found upon the following parameters: growth, food consumption, food utilization, survival, hematologic values, urinary analytical values, organ weights, and organ:body weight ratios. There were no gross or microscopic tissue changes attributable to ingestion of the test material. Therefore, NOAEL was considered to be 220.0 mg/kg body weight /day when Sprague-Dawley rats were treated wtih test substance.