Registration Dossier
Registration Dossier
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EC number: 278-137-2 | CAS number: 75214-69-6
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Aug - Sep 1983
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Sodium bis[4-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-3-hydroxy-N,N-dimethylbenzene-1-sulphonamidato(2-)]chromate(1-)
- EC Number:
- 278-137-2
- EC Name:
- Sodium bis[4-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-3-hydroxy-N,N-dimethylbenzene-1-sulphonamidato(2-)]chromate(1-)
- Cas Number:
- 75214-69-6
- Molecular formula:
- C36H34CrN10NaO8S2
- IUPAC Name:
- hydroxylamine
- Test material form:
- solid: granular
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Age at study initiation: 9 (male) - 14 (female) weeks
- Weight at study initiation: 166-181 g (male) and 150-169 g (female)
- Females: nulliparous and not pregnant
- Fasting period before study: 16 h
- Housing: Makrolon type 3 cage with softwood bedding
- Diet (e.g. ad libitum): Altromin®1324 Pellets ad lib. 4 h after dosing
- Water (e.g. ad libitum): ad lib.
- Acclimation period: at least 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 40 - 60
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12 h
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- Application volume: 20 mL/kg bw
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: four times during day 1, twice per day during days 2-15 (once per day during weekend)
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, behaviour
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- No mortality occured
- Clinical signs:
- No symptoms
- Body weight:
- No effect on body weight gain
- Gross pathology:
- No macroscopic findings
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 oral was determined to be >5000 mg/kg in female/male rats. The substance does not meet the classification criteria according to the CLP Regulation.
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