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Diss Factsheets

Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report date:
2017

Materials and methods

Test guidelineopen allclose all
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

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

Test animals

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.

Administration / exposure

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).

Results and discussion

Effect levels
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:
No clinical signs were observed in male or female animals after treatment during the observation period.
Body weight:
Body weights and body weight changes were within the expected range for this species and age of animals at the end of the study.
Gross pathology:
No abnormalities were found at necropsy examination performed on all animals at termination of the study.
Other findings:
No other findings.

Applicant's summary and conclusion

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.