Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report Date:
1998

Materials and methods

Principles of method if other than guideline:
Based on the EEC guideline (EEC directive 92/69, methods for the determination of toxicity, publication No. L 383A, B.1.: "Acute toxicity - oral", December 29, 1992) and modified according to the Acute Toxic Class Method by Schlede et al.
GLP compliance:
yes
Test type:
acute toxic class method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test substance: 2-ethylhexyl-cyanoacetate
- Chemical name: cyanoacetic acid 2-ethylhexyl ester
- Substance number: 96/219
- Batch number: ABL.NR . 13-9844
- CAS number: 13361-34-7
- Degree of purity/content: 98.5 g/100 g (GC)
- Date of manufacturing: 27-DEC-1995
- Physical state/appearance: liquid, yellowish, clear
- Stability under test conditions: The stability of the TS over the study period has been proven by reanalysis. The stability of the TS in olive oil DAB 10 for a time period of 4 hours was confirmed by analysis.
- Storage conditions: room temperature

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach, FRG
- Age at study initiation: young adult animals
- Weight at study initiation: 150 - 300 g (+/- 20% of the mean weight)
- Fasting period before study: at least 16 hours before administration
- Housing: single housing in stainless steel wire mesh cages, Type DK-III (Becker & Co., Castorp-Rauxel, FRG)
- Diet (e.g. ad libitum): Kliba-Labordiaet 343 (Klingenthalmuehle AG, Kaiseraugst, Switzerland) 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:
olive oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 40 g/100 ml
- Justification for choice of vehicle: the TS is insoluble in aqua bidest


DOSE VOLUME APPLIED: 5 ml/kg
Doses:
2000 mg/kg
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Individual body weights were determined shortly before application (day 0), weekly thereafter and at the end of the study. Recording of signs and symptoms several times on the day of administration, at least once each workday for the individual animals. A check for any dead or moribund animal was made each workday and once on saturdays, sundays and on public holidays.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: no mortality
Mortality:
No mortality occured.
Clinical signs:
Signs of toxicity noted in the male animals were impaired or poor general state, dyspnoea, apathy, staggering, ataxia, spastic gait and lacrimation. The female animals exhibited impaired general state, dyspnoea and abdominl position. The animals appeared normal within 5 days after application.
Body weight:
The expected body weight gain was observed in the course of the study.
Gross pathology:
No abnormalities were noted at necropsy of animals sacrificed at the end of the study.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information
Conclusions:
Under the conditions of this study the median lethal dose of the TS after oral application was found to be greater than 2000 mg/kg body weight for male and female rats.