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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
other information
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP / guideline study (limit test at 5000 mg/kg bw))

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report date:
1993

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
Limit test at 5000 mg/kg bw)
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Qualifier:
according to guideline
Guideline:
EPA OPP 81-1 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
methyl (2E)-2-methoxyimino-2-[2-[(2-methylphenoxy)methyl]phenyl]acetate
EC Number:
604-351-6
Cas Number:
143390-89-0
Molecular formula:
C18 H19 N O4
IUPAC Name:
methyl (2E)-2-methoxyimino-2-[2-[(2-methylphenoxy)methyl]phenyl]acetate
Details on test material:
- Name of test material (as cited in study report): Reg. No. 242 009 (test substance number: 91/180)
- Lot/batch No.: N 36 (= III C1); date of manufacturing: 1991-10-23
- Storage condition of test material: room temperature, exclusion of light
- Physical state: solid (powder) / light brown
- Analytical purity: 93.7% (Reversed-Phase - HPLC with UV-Detection)
- Stability under test conditions: the storage stability was guaranteed over the study period
- Other: the homogeneity of the test substance was confirmed by analysis (Reversed-Phase - HPLC with UV-Detection)

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: CHBB: Thom (SPF); from Dr. K. Thomae GmbH, D-W7950 Biberach, FRG
- Age at study initiation: young adult animals
- Weight at study initiation: animals of comparable weight (150 - 300 g; ±20% of the mean weight).
- Fasting period before study: 16 hours, but water was available ad libitum
- Housing: singly in stainless steel wire mesh cages, Type DK-III (Becker & Co., Castrop-Rauxel, FRG)
- Diet (e.g. ad libitum): Kliba-Labordiaet 343, Klingentalmuehle AG, CH-4303 Kaiseraugst, Switzerland
- Water (e.g. ad libitum): tap water
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
The animals were housed in fully air-conditioned rooms. There were no deviations from these ranges which influenced the results of the study.
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12 (6:00 - 18:00 / 18:00 - 6:00 hours)

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 0.5% tylose CB 30.000 CMC (carboxymethyl cellulose) in aqua bidest
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 50.000 g/100 ml suspension in vehicle
- Amount of vehicle (if gavage): 10.00 ml/kg
- Justification for choice of vehicle: acqueous formulation corresponds to the physiological medium
Doses:
5000 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 several times on the day of administration, at least once each workday for the individual animals. Individual body weights shortly before application (day 0), weekly thereafter and at the end of the study (before fasting period). General observation, mortality and moribunds twice each workday and once on saturdays, sundays and on public holidays
- Necropsy of survivors performed: yes, at the last day of the observation period. Withdrawal of food at least 16 hours before killing with CO2; then necropsy with grosspathology examination. Necropsy of all animals that died before as early as possible
Statistics:
none performed

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Remarks on result:
other: no abnormalities or mortalities at this unique dose level
Mortality:
no mortalities were observed in any of the test animals
Clinical signs:
other: no abnormalities
Gross pathology:
no pathologic findings noted

Any other information on results incl. tables

Table 1: Body weight development:

Treatment group (mg/kg)

Mean body weight after (for survival animals)

0 day

7 days

14 days

Males

Females

Males

Females

Males

Females

5000

178

171

235

199

275

217

Applicant's summary and conclusion