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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report date:
2017

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Version / remarks:
adopted on 17 December 2001
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
fixed dose procedure
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium hydrogen m-sulphonatobenzoate
EC Number:
241-602-5
EC Name:
Sodium hydrogen m-sulphonatobenzoate
Cas Number:
17625-03-5
Molecular formula:
C7H6O5S.Na
IUPAC Name:
sodium 3-sulfobenzoate
Test material form:
solid: particulate/powder
Details on test material:
White crystalline powder.
Specific details on test material used for the study:
Identity Sodium 3-sulfobenzoate
Alternative names 3-Sulpho Benzoic AcidMono Sodium Salt
SBA (3-Sodiosulfobenzoic Acid)
Sodium hydrogen m-sulphonatobenzoate
Label name 3-Sodiosulfobenzoic Acid
Batch no. 170103
Retest date 14 February 2019
Storage conditions Room temperature
RTC number 15432

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals or test system and environmental conditions:
Animal supply and acclimatisation
Species and strain: Rat, Hsd:Sprague Dawley SD
Sex Females (nulliparous and non-pregnant)
Age 6 to 7 weeks old
Supplier Envigo RMS s.r.l., San Pietro al Natisone (UD), Italy
Breeder Envigo RMS B.V., Kreuzelweg 53, 5961 NM Horst, Netherlands
Date of arrival 19 July 2017
Weight range at arrival 169.8-173.5 grams
Acclimatisation period At least 5 days
Veterinary health check During acclimatisation period

Animal husbandry
Animals per cage Up to 4 during the study; up to 5 during acclimatisation
Housing Polisulfone solid bottomed cages measuring 59.5×38×20 cm with nesting material provided into suitable bedding bags
Cage control Daily inspected and changed as necessary (at least 2 times/week)
Water drinking water supplied to each cage via a water bottle
Water supply ad libitum
Diet 4 RF 18 (Mucedola S.r.l., Via G. Galilei, 4, 20019, Settimo Milanese (MI) Italy)
Diet supply ad libitum throughout the study except for the dosing procedure
Room lighting Artificial (fluorescent tubes), daily light/dark cycle of 12/12 hours
Air changes Approximately 15 to 20 air changes per hour
Temperature range 22 °C ± 2 °C
Relative humidity range 55% ± 15%

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
0.5% aqueous solution of carboxymethylcellulose
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 0.5 % aquueous solution
- Amount of vehicle (if gavage): 10 mL/kg
- Justification for choice of vehicle: According to the properties of the test item, it may be dissolved/suspended in a 0.5% aqueous solution of carboxymethylcellulose or in other vehicles (i.e. distilled water, a vegetable or mineral oil).

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
Doses:
2000 mg/kg
No. of animals per sex per dose:
Initial sighting study: one female for 2000 mg/kg
Main study: four females for 2000 mg/kg
Control animals:
no
Details on study design:
Mortality and morbidity
Throughout the study all animals were checked twice daily.

Clinical signs
Animals were observed for clinical signs as indicated below:
– Day of dosing
· Session 1: on dosing
· Session 2: approximately 0.5 hour after dosing
· Session 3: approximately 2 hours after dosing
· Session 4: approximately 4 hours after dosing
– Daily thereafter for a total of 14 days (Session 1).

Body weight
All animals were weighed at allocation to the study (Day -1), on the day of dosing (Day 1) and on Days 2, 8 and 15.
Body weight change calculated for Days 2, 8 and 15 of the dosing phase was relevant to Day 1 of the phase.

Termination
All animals were sacrificed on Day 15.

Euthanasia method
All animals were sacrificed on Day 15.

Necropsy procedure
Necropsy was carried out on all animals (gross necropsy examination for both external and internal abnormalities, with particular attention to the gastro-intestinal tract).

Results and discussion

Preliminary study:
An initial sighting study was performed on a single female animal which was dosed at 2000 mg/kg. No mortality occurred and the animal was observed for a period of 14 days.
Effect levels
Sex:
female
Dose descriptor:
LD50
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
No mortality occurred.
Clinical signs:
No clinical signs were noted during the observation period in all animals treated.
Body weight:
The body weight changes were within the expected range for this species and age of animals during the study.
Gross pathology:
No abnormalities were observed at the necropsy examination performed on termination of the observation period in the sighting study animal and in all animals of the main study.
Other findings:
No other findings.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The lack of mortality demonstrates that the LD50 of the substance is greater than 2000 mg/kg body weight.
Executive summary:

The acute toxicity of Sodium 3-sulfobenzoate was investigated, according to OECD Guideline 420, following a single oral administration (10 mL/kg of an aqueous solution containing sodium 3-sulfobenzoate, 200 mg/mL and carboxymethylcellulose 0.5%, corresponding to 2000 mg/kg of Sodium 3-sulfobenzoate) to the Sprague Dawley rat followed by a 14-day observation period.

Mortality did not occur and no clinical signs considered related to the treatment were observed in the animals following dosing at 2000 mg/kg.

These results indicate that the test item, Sodium 3-sulfobenzoate, has no toxic effect on the rat following oral administration of a single dose at 2000 mg/kg. The lack of mortality demonstrates the LD50 to be greater than 2000 mg/kg body weight.