Registration Dossier
Registration Dossier
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Reaction mass of Amines, C10-14-branched and linear alkyl, [2,4-dihydro-4-[(2-hydroxy- 4-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)][2,4-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)]chromate(1-); Amines, C10-14-branched and linearalkyl, bis[2,4-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)]chromate(1-) (1:1) and Amines, C10-14-branchedand linear alkyl, bis[2,4-dihydro-4-[(2-hydroxy-4-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)] chromate(1-)
EC number: 943-144-8 | CAS number: -
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- Feb 1980 to Mar 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Amines, C10-14-branched and linear alkyl, bis[2,4-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)]chromate(1-) (1:1)
- EC Number:
- 284-628-2
- EC Name:
- Amines, C10-14-branched and linear alkyl, bis[2,4-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)]chromate(1-) (1:1)
- Cas Number:
- 84961-40-0
- Molecular formula:
- C32H22CrN10O8.C10-14H21-29NH2
- IUPAC Name:
- Amines, C10-14-branched and linear alkyl, bis[2,4-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)]chromate(1-) (1:1)
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Name of test substance as cited in report: Neozapon-orange Vers. 1187 (pulvrig)
- Substance number as cited in report: 79-594
FORM AS APPLIED IN THE TEST
Suspension
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Remarks:
- Wiga
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: males, 170-190 g; females: 160-170 g
- Fasting period before study: 15 to 20 hours
- Diet: Herilan MRH-Haltung; H Eggersmann KG
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle (%, g/v): from low to high dose: 16.5; 24.2; 35.6; 35.6; 35.6
- Amount of vehicle (mL/kg): from low to high dose: 5.0; 5.0; 5.0; 7.3; 10.8
MAXIMUM DOSE VOLUME APPLIED:
10.8 mL/kg - Doses:
- 825; 1210; 1780; 2610; 3830 mg/kg
- No. of animals per sex per dose:
- 5, except for the 2610 mg/kg dose in males which was tested in 4 animals
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: < 15min, 15 min, 30 min, 1 hour, 4 hours, 1 day, 2 days, 5 days, 6 days, 7 days, 8 days, 9 days, 12 days, 13 days, 14 days
- Frequency of weighing: 2-4, 7 and 13 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 1 400 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 1 200 mg/kg bw
- Based on:
- test mat.
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 1 600 mg/kg bw
- Based on:
- test mat.
- Mortality:
- - 825 mg/kg: no mortality was observed
- 1210 mg/kg: males, 3 animals died after 7 days; females, 3 animals died after 7 days
- 1780 mg/kg: males, 1 animal died after 7 days; females, 4 animals died after 7 days
- 2610 mg/kg: males, 4 (all) animals died after 7 days; females, 5 (all) animals died after 7 days
- 3830 mg/kg: males, 5 (all) animals died after 7 days; females, 5 (all) animals died after 7 days - Clinical signs:
- other: - 825 mg/kg: Observed symptoms included orange faeces, orange urine, diarrhoea - 1210 mg/kg: Observed symptoms included orange faeces, orange urine, diarrhoea - 1780 mg/kg: Observed symptoms included orange faeces, orange urine, diarrhoea - 2610 mg/kg:
- Gross pathology:
- - Animals that died during the study: heart, acute dilation of the atria; acute hyperaemia; organs/adipose tissue/musculature: substance stained.
- Sacrificed animals: no effects observed
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
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