Registration Dossier
Registration Dossier
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EC number: 260-480-4 | CAS number: 56966-52-0
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study
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:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 5-chloro-2-(2,4-dichlorophenoxy)aniline
- EC Number:
- 260-480-4
- EC Name:
- 5-chloro-2-(2,4-dichlorophenoxy)aniline
- Cas Number:
- 56966-52-0
- Molecular formula:
- C12H8Cl3NO
- IUPAC Name:
- 5-chloro-2-(2,4-dichlorophenoxy)aniline
- Details on test material:
- - Name of test material (as cited in study report): FAT 80'023/G
- Physical state: solid
- Analytical purity: no data
- Lot/batch No.: Partie 804
- Stability under test conditions: no data
- Storage condition of test material: no data
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Tif: RAIf
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: no data
- Age at study initiation: 7 to 8 weeks
- Mean weight at study initiation (± SD): Males: 174 ± 2.9 g; Females: 169 ± 3.7 g.
- Fasting period before study: overnight
- Housing: in groups of 5 in Macrolon cages type 3
- Diet: NAFAG No. 890, NAFAG, Gossau SG, ad libitum
- Water: ad libitum
- Acclimation period: minimum of 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 20°C
- Humidity (%): 55 ± 10 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 10 hours light per day
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: polyethylene glycol 400
- Details on oral exposure:
- VEHICLE
- Amount of vehicle (if gavage): 10 + 20 mL/kg body-weight
MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg body weight
DOSAGE PREPARATION:
FAT 80'023/G was diluted to achieve a concentration suitable for the dose levels selected for this test. - Doses:
- 500; 1000; 2,500 and 5,000 mg/kg body weight
- No. of animals per sex per dose:
- 5
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Physical condition and rate of deaths were monitored throughout the whole observation period. Bodyweights were recorded immediately prior to dosing (control weights) and at 7 and 14 days.
- Necropsy of survivors performed: yes, at the end of the observation period.
- Other examinations performed: Autopsies of dead animals, whenever they died. - Statistics:
- The LD50, including the 95 % confidence limits were calculated by the logit model.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 2 287 mg/kg bw
- 95% CL:
- 1 607 - 3 876
- Mortality:
- Males: No mortality was observed in the dose groups of 500, 1000 and 2500 mg/kg body weight. 5 / 5 animlas died within 24 hours in the high dose group of 5000 mg/kg body weight.
Females: No mortality was observed in the low dose group of 500 mg/kg body weight. With 1000 mg/kg body weight one animal died within 3 days. In the 2500 mg/kg body weight dose group one animal died after 3, 4, 5 and 9 days, respectively. In the highest dose group of 5000 mg/kg body weight 3 animals died within 24 hours, one animal within 3 and one within 4 days. - Clinical signs:
- other: The surviving animals recovered within 8 to 10 days. 500 mg/kg body weight: dyspnoea (day 1 - 6, slight), exophthalmos (day 1 - 7, slight), ruffeled fur (day 1 - 5, slight), curved body position (day 1 - 3, slight). 1000 mg/kg body weight: sedation (hour
- Gross pathology:
- No gross organ changes were observed.
- Other findings:
- No data
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the test results the substance is considered to be not acute toxic via oral application.
- Executive summary:
The acute oral LD50 of FAT 80'0 23/G in rats of both sexes observed over a period of 14 days is 2287 (1607-3876) mg/kg. The test material is therefore not toxic to the rat by this route of administration.
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