Registration Dossier
Registration Dossier
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EC number: 267-090-3 | CAS number: 67786-14-5
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 24 Jan - 09 Feb 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Sodium 6-amino-4-hydroxy-5-[[2-(trifluoromethyl)phenyl]azo]naphthalene-2-sulphonate
- EC Number:
- 267-090-3
- EC Name:
- Sodium 6-amino-4-hydroxy-5-[[2-(trifluoromethyl)phenyl]azo]naphthalene-2-sulphonate
- Cas Number:
- 67786-14-5
- Molecular formula:
- C17H12F3N3O4S.Na
- IUPAC Name:
- sodium 6-amino-4-hydroxy-5-[[2-(trifluoromethyl)phenyl]azo]naphthalene-2-sulphonate
- Test material form:
- solid: particulate/powder
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: 8 (male) - 10 (female) weeks
- Weight at study initiation: 178 g (mean male) and 170 g (mean female)
- Females: nulliparous and not pregnant
- Fasting period before study: 4 - 16 h
- Housing: Makrolon type 3 cage with softwood bedding
- Diet (e.g. ad libitum): ad lib. 3 h after dosing
- Water (e.g. ad libitum): ad lib.
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24°C
- Humidity (%): 40 - 60 % rh
- 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:
- 10 mL/kg bw
- Doses:
- 2000 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:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occured
- Clinical signs:
- No symptoms observed
- Body weight:
- No effect on body weight gain
- Gross pathology:
- No macroscopic findings observed
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 was determined to be >2000 mg/kg in female/male rats. The substance does not meet the classification criteria according to the CLP Regulation.
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