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Toxicological information

Acute Toxicity: oral

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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:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
Three test groups (three doses) consisting of 5 animals/sex each were treated by single gavage application with an emulsion of the test substance. The animals were observed for mortality and for clinical symptoms of toxicity. At the end of the observation period of 14 days, the surviving animals were sacrificed for the purpose of necropsy; animals that died during the observations period also were subjected to necropsy.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): EMI-2,4 Fluessig

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Dr. K. Thomae GmbH, D-7950 Biberach, FRG
- Weight at study initiation: 170-189 g
- Fasting period before study: yes
- Housing: 5 animals per stainless steel mesh cage, type DK-III (Becker & Co., Castrop-Rauxel, FRG)
- Diet (e.g. ad libitum): Kliba-Labordiaet, FA, Klingentalmuehle AG, CH-4303 Kaiseraugst, Switserland, ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: at least 1 week

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)
Remarks:
0.5 % emulsion
Details on oral exposure:
VEHICLE
- Concentration in vehicle (w/v): 10, 6.81, 4.64 mg/mL

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
Doses:
1000, 681, 464 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 day of administration, at least once each workday. Check for moribund and dead animals twice each workday and once on holidays.
- Necropsy performed on died animals as well as sacrificed animals.
- Other examinations performed: clinical signs and body weight.

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
ca. 754 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Value from interpolation
Sex:
female
Dose descriptor:
LD50
Effect level:
ca. 681 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 731 mg/kg bw
Based on:
test mat.
Remarks on result:
other: value from interpolation
Mortality:
1000 mg/kg bw: all animals died within 1 day
681 mg/kg bw: 1 male and 2 female animals died within 1 day
464 mg/kg bw 1 female animal died within 1 day
Clinical signs:
Dyspnea, abnormal position. Apathy, staggering, tremors, twitching, convulsion of the jaws, fibr. contractions, intense yellow urine, piloerection, poor general state
Body weight:
Recorded but not specifically mentioned
Gross pathology:
Animals that died (male and female): general congestive hyperemia
Sacrificed animals (male and female): no abnormalies detected

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria