Registration Dossier
Registration Dossier
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EC number: 249-020-3 | CAS number: 28443-50-7
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
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
Test material
- Reference substance name:
- 2-amino-5-chlorophenol
- EC Number:
- 249-020-3
- EC Name:
- 2-amino-5-chlorophenol
- Cas Number:
- 28443-50-7
- Molecular formula:
- C6H6ClNO
- IUPAC Name:
- 2-amino-5-chlorophenol
- Details on test material:
- Purity: 97 - 98%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: HOECHST AG, Kastengrund, SPF-Zucht
- Age at study initiation: no data
- Weight at study initiation: males: 174 g - 216 g (average 195 g); females: 184 g - 223 g (average 203 g)
- Fasting period before study: about 16 hours
- Housing: 5 animals per makrolon cage
- Diet: Altromin 1324 rat diet, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2°C
- Humidity (%): 55 +/- 10%
- Air changes (per hr): no data
- Photoperiod: 12 hrs dark / 12 hrs light
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: sesame oil
- Details on oral exposure:
- Concentration in vehicle: 25 %
- Doses:
- 1000, 1600, 2500, 4000 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 weighing: weekly
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology, histopathology
Results and discussion
Effect levelsopen allclose all
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 2 220 mg/kg bw
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 3 670 mg/kg bw
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information according to CLP-criteria for acut oral toxicity Criteria used for interpretation of results: EU
- Conclusions:
- In the acute oral toxicity study cyanoses was observed in male and female rats already at dose levels below 2000 mg/kg bw. Based on this clinical observation, the fact that the substance belongs to the group of aromatic amines known to cause methemoglobinemia and that humans are generally more sensitive than rodents regarding this effect, a classification as STOT SE2, H371 is justified according to Regulation 1272/2008/EC.
The LD50 value for acute oral toxicity is 3670 mg/kg bw in male Wistar rats and 2220 mg/kg bw in female Wistar rats.
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