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EC number: 939-651-9 | CAS number: 1474044-70-6
Toxicological information
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- April 7-21, 1994
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline test; GLP compliance, full documentation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.1100 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- NAXONATE CX and SAR 33-55 (the later is identified as CAS No.28088-63-3 in other tests performed at the same time)
- IUPAC Name:
- NAXONATE CX and SAR 33-55 (the later is identified as CAS No.28088-63-3 in other tests performed at the same time)
- Reference substance name:
- Calcium xylenesulphonate
- EC Number:
- 248-829-9
- EC Name:
- Calcium xylenesulphonate
- Cas Number:
- 28088-63-3
- IUPAC Name:
- calcium xylenesulphonate
- Details on test material:
- - Name of test material (as cited in study report): SAR 33-55 and NAXONATE CX
- Molecular formula (if other than submission substance): no data
- Molecular weight (if other than submission substance): no data
- Substance type: organic
- Physical state: clear liquid
- Analytical purity: 31.2% active
- Impurities (identity and concentrations): 64.8% water
- Purity test date: Feb 16, 1994
- Lot/batch No.: 9401
- Expiration date of the lot/batch: Feb 1995
- Stability under test conditions: stable
- Storage condition of test material: no data
- Other:
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hazelton Research Products, Michigan
- Age at study initiation: 5 months
- Weight at study initiation: nakes 2944-3091g and females 2915-3155g
- Fasting period before study: no data
- Housing: individually in hanging stainless steel wire mesh cages
- Diet: up to 125 g/day
- Water: ad libitum
- Acclimation period: minimum of 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): controlled but no values reported
- Humidity (%): controlled but no values reported
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
- other: The animals were maintained in accordance with the recommendations contained in the D.H.H.S. Publication "Guuide for the Care and Use of Laboratory Animals".
IN-LIFE DATES: From: April 7 To: April 21
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- On the day prior to dosing, the hair was removed from the back of each rabbit with an electric clipper. The skin was left intact. The test material was applied once, as received, at a dose of 2000 mg/kg then spread evenly to cover 100% of the test site which was approximately 10% of the body surface. The test site was covered with a 1 x 1 inch gauze pad, wrapped with a gauze bandage, overwrapped with plastic wrap and then sealed with elastoplast tape. A collar was placed on each animal. The test site was washed 24 hours later with water and towel dried.
- Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/Kg
- No. of animals per sex per dose:
- 5
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations at 1,2 and 4 hours on day one then twice daily for the next 13 days. weighing prior to dosing, on day 8 and at study termination.
- Necropsy of survivors performed: yes
- Other examinations performed: pharmacotoxic signs
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- >= 2 000 mg/kg bw
- Remarks on result:
- other: no mortality
- Mortality:
- none
- Clinical signs:
- other: 4 of the 10 animals displayed no visible abnormal signs. Erythema was noted on day 3 in six animals with desquamation additionally observed on day 9 in one animal.
- Gross pathology:
- No visible abnormalities in 6 of the 10 animals. The remaining 4 displayed focal or multifocal red discoloration of the treated skin with one animal additionally displaying desquamation of the same site.
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- The dermal LD50 is > 2000 mg/kg bw
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