Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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:
1988
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

Constituent 1
Chemical structure
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

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