Registration Dossier
Registration Dossier
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EC number: 204-482-5 | CAS number: 121-57-3
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study according to OECD test guideline 423 under GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- yes
- Remarks:
- once a slighlty decreased environmental temperature
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- Sulphanilic acid
- EC Number:
- 204-482-5
- EC Name:
- Sulphanilic acid
- Cas Number:
- 121-57-3
- Molecular formula:
- C6H7NO3S
- IUPAC Name:
- 4-aminobenzene-1-sulfonic acid
- Details on test material:
- - Name of test material (as cited in study report): SULFANTLIC ACID TECHNICAL GRADE
- Physical state: grey powder
- Analytical purity: 99.12%
- Lot/batch No.: M001/09
- Expiration date of the lot/batch: 01.10.2011
- Storage condition of test material: dry at room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage JANV1ER (53940 Le Genest St Isle — France)
- Age at study initiation: 8 weeks
- Weight at study initiation: 178 g to 197 g
- Housing: Healthy female rats were housed by group of three in solid-bottomed clear polycarbonate cages with a
stainless steel mesh lid. Each cage contains sawdust bedding which was changed at least 2 times a
week. Each cage was installed in conventional air conditioned animal husbandry.
- Diet (e.g. ad libitum): Food was removed at D-1 and then redistributed 4 hours after the test item administration
- Water (e.g. ad libitum): ad libitum
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 -26 °C
- Humidity (%): 40 -58%
- Air changes (per hr): aprox. 15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- distilled
- Details on oral exposure:
- The preparation was administered by gavage with a volume of 10 mL/kg body weight using a suitable syringe graduated fitted with an oesophageal metal canula.
- Doses:
- 300 and 2000 mg/kg bw
- No. of animals per sex per dose:
- 6
- Control animals:
- no
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- none
- Clinical signs:
- other: none
- Gross pathology:
- The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In a study according to OECD test guideline 423 (acute oral toxicity) under GLP, the LD50 (rat) of the test substance was determined to be > 2000 mg/kg bw.
- Executive summary:
The test substance was administered to a group of 6 female Sprague Dawley rats at the single dose of 300 mg/kg body weight and to a group of 6 female Sprague Dawley rats at the single dose of 2000 mg/kg body weight. The experimental protocol was established on the basis of the official method as defined in the O.E.C.D, guideline N° 423 dated December 17th, 2001. No mortality occurred during the study at 300 mg/kg or at 2000 mg/kg body weight. No clinical signs related to the administration of the test substance were observed. The body weight development of the animals remained normal throughout the study. The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes. In conclusion, the LD50 of the test isubstance is higher than 2000 mg/kg body weight by oral route in the rat.
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