Registration Dossier
Registration Dossier
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EC number: 267-224-0 | CAS number: 67827-60-5
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- From August 24 to September 07, 1979
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: standards of AAALAC 16 CFR 1500.3
- Deviations:
- not specified
- Principles of method if other than guideline:
- Similar to OECD guideline 403 with substancial deviation related to the limit test.
- GLP compliance:
- no
- Remarks:
- pre GLP
- Test type:
- fixed concentration procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Sodium 1-amino-4-[[3-[(benzoylamino)methyl]-2,4,6-trimethylphenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate
- EC Number:
- 267-224-0
- EC Name:
- Sodium 1-amino-4-[[3-[(benzoylamino)methyl]-2,4,6-trimethylphenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate
- Cas Number:
- 67827-60-5
- Molecular formula:
- C31H26N3O6S.Na
- IUPAC Name:
- sodium 1-amino-4-({3-[(benzoylamino)methyl]-2,4,6-trimethylphenyl}amino)-9,10-dioxo-9,10-dihydroanthracene-2-sulfonate
- Test material form:
- not specified
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Ace Animals.
- Age at study initiation: approximately 8 weeks old.
- Weight at study initiation: between 209 - 298 g.
- Housing: suspended wire mesh cages (20" x 10" x7").
- Diet: Fresh Purina rat chow ad libitum (except during dosing).
- Water: ad libitum (except during dosing).
- Acclimation period: at least one week.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 21°C
- Air changes: continuos air flow.
Administration / exposure
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- whole body
- Vehicle:
- air
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure chamber volume: 435 liter stainless steel chamber
- Method of holding animals in test chamber: the animal room, reserved exclusively for rodents on acute tests, was maintained at 20 - 21°C and was kept clean
- System of generating vapours: Harvard pum
- Temperature: 20 - 21°C
- Total Volume of Air: 2175 liter/minute
TEST ATMOSPHERE
- Brief description of analytical method used: the test material was introduced into a distilling flask at a constant rate by use of a Harvard pump. The vapors generated were introduced into the air stream. The dosage amount was calculated from the air flow and the amount of liquid material used.
VEHICLE
- Concentration of test material in vehicle: 0.006 mg/L - Analytical verification of test atmosphere concentrations:
- not specified
- Duration of exposure:
- ca. 4 h
- Concentrations:
- 0.006 mg/L
- No. of animals per sex per dose:
- 5 per sex per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed hourly during dosing and as late in the day as possible and then once daily for Days 1-14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology.
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 0.006 mg/L air (nominal)
- Based on:
- test mat.
- Exp. duration:
- 14 d
- Sex:
- male/female
- Dose descriptor:
- LC0
- Effect level:
- ca. 0.006 mg/L air (nominal)
- Based on:
- test mat.
- Exp. duration:
- 14 d
- Mortality:
- No animals death
- Clinical signs:
- other: animal #5 exhibited ptosis and dyspnea on Day 2. Animal #6 exhibited grooming at hour 1. At all other times all animals appeared normal.
- Body weight:
- Day 0: in a range of 209 and 298 g
Day 7: in a range of 218 and 348 g
Day 14: in a range of 226 and 386 g
Any other information on results incl. tables
NECROPSY OBSERVATIONS: All animals were normal
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- LC50 > 0.006 mg/L
LC0 = 0.006 mg/L - Executive summary:
Method:
Standards of AAALAC 16 CFR 1500.3. Similar to OECD guideline 403 with substancial deviation related to the limit test.
Observations:
All animals survived this test in generally good health. One animal was observed to have dyspnea on day 2.
All animals were normal at necropsy.
Results:
LC50 > 0.006 mg/L LC0 = 0.006 mg/L.
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