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Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 23 OCT 1984 to 27 NOV 1984
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (OECD 401)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report date:
1984

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
o-anisidine
EC Number:
201-963-1
EC Name:
o-anisidine
Cas Number:
90-04-0
Molecular formula:
C7H9NO
IUPAC Name:
2-methoxyaniline
Details on test material:
- Name of test material (as cited in study report): Echtrot BB Base flüssig

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-breed
- Weight at study initiation: males mean: 199.4 g; females mean: 188.1 g
- Fasting period before study: 16 h
- Housing: grouped (5 animals per cage) in macrolon cages (type 4) in fully air conditioned rooms
- Diet: rats diet Altromin1324 (Altromin GmbH, Lage/Lippe), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-3
- Humidity (%): 50+/-20
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: sesame oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 25% (w/v)

MAXIMUM DOSE VOLUME APPLIED: 16 ml/kg bw

Doses:
1250, 1600, 1800, 2000, 2500, 3150 and 4000 mg/kg bw
(corresponding to 750, 960, 1080, 1200, 1500, 1890 and 2400 mg/kg bw of submission substance only)
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

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
1 890 mg/kg bw
Remarks on result:
other: (corresponding to 1134 mg/kg bw of submission substance)
Sex:
male
Dose descriptor:
LD50
Effect level:
1 950 mg/kg bw
Remarks on result:
other: (corresponding to 1170 mg/kg bw of submission substance)
Sex:
female
Dose descriptor:
LD50
Effect level:
1 800 mg/kg bw
Remarks on result:
other: (corresponding to 1080 mg/kg bw of submission substance)
Mortality:
- deaths occurred in between 20 minutes and about 60 h after the dosage
dosage group [mg/kg bw]: lethality in male animals and lethality in female animals
1250: 0/5 and 0/5
1600: 0/5 and -
1800: 3/5 and 2/5
2000: 3/5 and 4/5
2500: 4/5 and 5/5
3150: - and 5/5
4000: - and 5/5
Clinical signs:
- lower dose-groups: squatting, staggering gait, reduced spontaneous activity, dizziness and respiratory depression
- higher dose-groups: abdominal position, negative righting reflex, orange urine, pale skin and at doses of more than 2500 mg/kg bw, in some cases respiratory sounds were reported
- with exception of one male animal dosed with 1800 mg/kg bw (recovery within 11 days), in all animals no signs of toxicity were seen 4 days after application
Body weight:
- body weight development was not impaired
Gross pathology:
- congestion of blood vessels in the gastrointestinal tract and lungs, a yellow-red foamy liquid in the intestine, and haemorrhages in stomach, intestine and urinary bladder
- animals sacrificed at the end of the observation period showed no macroscopically visible changes

Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
Single oral application of test material "Echtrot BB Base flüssig" caused lethality in male and female Wistar rats thus resulting in a LD 50 of 1890 mg/kg bw (corresponding to 1134 mg/kg bw submission substance only). The test material contains relevant amounts of the submission substance. Therefore the test results are adequate to fulfil the endpoint requirements.
Executive summary:

Male and female Wistar rats were subjected to test acute oral toxicity according to a standard acute method (OECD TG 401). The test material "Echtrot BB Base flüssig" was administered by gavage at different doses. Animals showed a range of clinical signs and lethality (combined with visible changes in necropsy) was observed during the 14 days observation period, leading to a LD50 of 1890 mg/kg bw (corresponding to 1134 mg/kg bw submission substance; male and female rats combined).

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