Sodium hydrogen m-sulphonatobenzoate

Endpoint summary

Description of key information

Acute oral toxicity

The acute toxicity of Sodium 3-sulfobenzoate was investigated, according to OECD Guideline 420, following a single oral administration (10mL/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 2000mg/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 2000mg/kg. The lack of mortality demonstrates the LD50 to be greater than 2000 mg/kg body weight.

Acute dermal toxicity

The acute toxicity of Sodium 3-sulfobenzoate was investigated following dermal administration of a single dose to the rat according to OECD Guideline 402. A single dose of 2000 mg/kg was administered to a group of 5 male and 5 female animals for 24 hours. After 14 days, all animals were killed and subjected to necropsy examination.

No mortality occurred and no signs of toxicity were observed in male or female animals during the observation period. The body weight changes observed during the study were within the expected range for this species and age of animals.

No significant abnormalities were found at necropsy in the animals at termination of the study. No abnormalities were observed at the treated site. These results indicate that the test item, Sodium 3-sulfobenzoate, has no toxic effect on the rat following dermal exposure over a 24 hour period at a level of 2000 mg/kg. The lack of mortality demonstrates the LD50 to be greater than 2000 mg/kg.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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

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

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

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%

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).

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.

Sex:

female

Dose descriptor:

LD50

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

No mortality occurred.

Clinical signs:

other: No clinical signs were noted during the observation period in all animals treated.

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

24 February 1987

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

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
Expiry date 14 February 2019
Storage conditions Room temperature
RTC number 15432

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Animal supply and acclimatisation
Species and strain Rat, Hsd: Sprague Dawley SD
Sex Males and females (nulliparous and non-pregnant)
Age 6 to 8 weeks old
Weight at order 176 to 200 grams
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 30 August 2017
Weight range at arrival 189.0 to 190.3 grams (for females); 200.3 to 207.2 grams (for males)
Acclimatisation period At least 5 days
Veterinary health check During acclimatisation period

Animal husbandry
Animals per cage Up to 5 of one sex during acclimatisation; individually caged during the study
Housing Clear polysulfone H-Temp solid bottomed cages (Tecniplast Gazzada S.a.r.l., Buguggiate, VA, Italy) measuring 59.5×38×20 cm during acclimatisation period and 42.5×26.6×18.5 cm during the study with nesting material provided into suitable bedding bags.
Cage control Daily inspected and changed as necessary (at least 3 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
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%

Records of analyses of water and diet are kept on file at RTC. Components present in the drinking water or diet are not at a level likely to interfere with the purpose or conduct of the study. Actual housing conditions were monitored and recorded, and records retained. No relevant deviations occurred.

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

Frequency of treatment
Once only, on the day of dosing (Day 1 of the dosing phase).

Treatment area preparation
On the day before dosing (Day 1 of the allocation phase), a single area was clipped free of hair (by an electric clipper equipped with a suitable blade) on the dorsal surfaces of the trunk of each animal (approximately 10% of body surface). Care was taken to avoid damage to the skin.

Dose calculation
Aliquots were weighed according to the body weight of each animal measured prior to dosing.

Dosing procedure
An aliquot of the supplied test item was spread evenly over an area of approximately 10% of the body surface. A patch of surgical gauze covered by a strip of synthetic film was placed over the treated site and the whole assembly held in place by encircling the trunk of the animal with a length of elastic adhesive bandage, this forming a semi-occlusive barrier.

Exposure time
The animals remained in contact with the test item for 24 hours.

Washing procedure
After exposure, the adhesive bandage and gauze patch were removed. The treatment area was cleaned by gentle swabbing of the skin with cotton wool soaked with lukewarmwater.

Duration of exposure:

The animals remained in contact with the test item for 24 hours.

Doses:

A single dose of 2000 mg/kg.

No. of animals per sex per dose:

A group of 5 male and 5 female animals.

Control animals:

not required

Details on study design:

Experimental design
A single group of 5 male and 5 female animals was dosed at a level of 2000 mg/kg.

Selection/Allocation
Random at arrival. The body weight of each individual was within 20% of the mean and within the range of 200-300 grams. At allocation, animals were individually caged.
Animals were univocally numbered within the study. The animal numbers together with the study number ensured a unique animal numbering for any study employing computerised data collection. The computerised system used in this study was Pristima, version 6.4.1.

Animal Identification
Animals were permanently identified, following arrival, by a combination of ear notch (units) and tattoo on the hind feet. Males and females were identified by even and odd numbers, respectively.

Dosing
Frequency of treatment
Once only, on the day of dosing (Day 1 of the dosing phase).

In vivo observations

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 1 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.

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

Terminal studies
Termination
All animals were sacrificed on Day 15.

Euthanasia method
Animals were sacrificed by carbon dioxide narcosis.

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

Dose descriptor:

LD50

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

No mortality was observed in male or female animals after treatment during the observation period.

Clinical signs:

other: No clinical signs were observed in male or female animals after treatment during the observation period.

Gross pathology:

No abnormalities were found at necropsy examination performed on all animals at termination of the study.

Other findings:

No other findings.

Interpretation of results:

GHS criteria not met

Conclusions:

No mortality occurred following dosing and no signs of toxicity were observed.
These results indicate that the test item, Sodium 3-sulfobenzoate, has no toxic effect on the rat following dermal exposure over a 24 hour period at a level of 2000 mg/kg. The lack of mortality demonstrates the LD50 to be greater than 2000 mg/kg.
European Directives concerning the classification, packaging and labelling of dangerous substances (Council Regulation (EC) No. 1272/2008 and subsequent revisions) would suggest the following:
Classification - No category
Signal word - No signal word required
Hazard statement - No hazard statement required

Executive summary:

The acute toxicity of Sodium 3-sulfobenzoate was investigated following dermal administration of a single dose to the rat according to OECD Guideline 402. A single dose of 2000 mg/kg was administered to a group of 5 male and 5 female animals for 24 hours. After 14 days, all animals were killed and subjected to necropsy examination.

No mortality occurred and no signs of toxicity were observed in male or female animals during the observation period. The body weight changes observed during the study were within the expected range for this species and age of animals.

No significant abnormalities were found at necropsy in the animals at termination of the study. No abnormalities were observed at the treated site. These results indicate that the test item, Sodium 3-sulfobenzoate, has no toxic effect on the rat following dermal exposure over a 24 hour period at a level of 2000 mg/kg. The lack of mortality demonstrates the LD50 to be greater than 2000 mg/kg.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Justification for classification or non-classification

According to CLP Regulation the substance is not classified for acute oral and dermal toxicity since:

• Rat, oral LD50 > 2000 mg/kg bw
• Rat, dermal LD50 > 2000 mg/kg bw.

No data are available for acute inhalation toxicity.