Registration Dossier
Registration Dossier
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EC number: 207-256-4 | CAS number: 456-04-2
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, well documented with accepted restrictions (no GLP).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
- Principles of method if other than guideline:
- BASF-Test
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- α-chloro-4-fluoroacetophenone
- EC Number:
- 207-256-4
- EC Name:
- α-chloro-4-fluoroacetophenone
- Cas Number:
- 456-04-2
- Molecular formula:
- C8H6ClFO
- IUPAC Name:
- 2-chloro-1-(4-fluorophenyl)ethan-1-one
- Details on test material:
- - Name of test material (as cited in study report): omega-chlor-para-fluoracetophenon [German]
- Physical state: aqueous solution
- Analytical purity: 98 %, technical grade
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach, FRG
- Age at study initiation: no data
- Weight at study initiation: mean weights: males 189.25 g, females 181.25 g (animals of comparable weight: ± 20 % of the mean weight)
- Fasting period before study: 16 hours before administration
- Housing: 5/cage
- Diet: Kliba Labordiaet 343, ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 1 wk
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 4.64, 2.15, 1.00, 0.464 % (w/v)
- Amount of vehicle (if gavage): 10 ml
- Justification for choice of vehicle: aqueous formulation corresponds to the physiological medium
MAXIMUM DOSE VOLUME APPLIED: 464.0 mg/kg bw - Doses:
- 464.0, 215.0, 100.0, 46.4 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: recording of signs and symptoms severeal times on the day of administration, at least once each workday; check for moribund and dead animals twice each workday and once on holidays; weighing on day 7 and day 13
- Necropsy of survivors performed: yes, gross-pathological examination
- Other examinations performed: clinical signs, body weight
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- ca. 248 mg/kg bw
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- ca. 215 mg/kg bw
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 215 - < 464 mg/kg bw
- Mortality:
- 464 mg/kg bw:
Males and females: 5/5 each after 1 d
215 mg/kg bw:
Males: 0/5
Females: 3/5 after 1 d
100 mg/kg bw:
Males: 0/5
Females: 1/5 after 14 d (probably not due to test substance, therefore not considered for LD50 determination)
46.4 mg/kg bw:
Males and females: 0/5 each - Clinical signs:
- other: 464 mg/kg: Males and females: dyspnea, apathy, staggering, piloerection, diarrhea, poor general state 215 mg/kg bw: males and females: dyspnea, apathy, piloerection, impaired general state, poor general state 100 mg/kg bw: Males: piloerection Fema
- Gross pathology:
- Deceased animals (male and female):
General congestion; glandular stomach: reddened mucosa
One female of the 100 mg/kg bw group: perforation of stomach with fibrinous peritonitis
Sacrificed animals (male and female):
46.4 mg/kg bw: no pathological findings noted.
100 mg/kg bw: forestomach: thickening of the wall.
215 mg/kg bw: forestomach: thickening of the wall, intraabdominal adhesions.
Any other information on results incl. tables
Mean body weights (g):
Males:
| Dose (mg/kg bw) | ||||
| Time | 464.0 | 215.0 | 100.0 | 46.4 |
| Beginning | 196 | 190 | 189 | 182 |
| 7 d | - | 237 | 251 | 259 |
| 13 d | - | 273 | 282 | 291 |
Females:
| Dose (mg/kg bw) | ||||
| Time | 464.0 | 215.0 | 100.0 | 46.4 |
| Beginning | 180 | 180 | 178 | 187 |
| 7 d | - | 211 | 208 | 226 |
| 13 d | - | 222 | 222 | 239 |
Applicant's summary and conclusion
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