Registration Dossier
Registration Dossier
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EC number: 607-301-1 | CAS number: 23996-53-4
Acute Toxicity: oral
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:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- Cited as Directive 92/69/EEC, B.1
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- yes
- Remarks:
- (first step: 500 mg/kg bw; second step: 2000 mg/kg bw)
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- Imidazole-1-propionitrile(8CI);1-(2-Cyanoethyl)imidazole
- EC Number:
- 607-301-1
- Cas Number:
- 23996-53-4
- Molecular formula:
- C6H7N3
- IUPAC Name:
- Imidazole-1-propionitrile(8CI);1-(2-Cyanoethyl)imidazole
- Details on test material:
- - Name of test substance (as cited in study report): Cyanethylimidazol
- Analytical purity: > 95%
- Batch No.: K 94/1
- Substance No.: 96/124
- Physical state: liquid; brownish, clear (below 8 °C: solid)
- Storage: refrigerator
Constituent 1
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, Biberach, FRG
- Age at study initiation: young adult animals
- Weight at study initiation: 150 - 300 g
- Fasting period before study: 16 h
- Housing: single housing, stainless steel wire mesh cages, type DK-III (Becker & Co., Castrop-Rauxel, FRG
- Diet: Kliba-Labordiaet 343, Klingentalmuehle AG, Kaiseraugust, Switzerland; ad libitum
- Water: tap water; ad libitum
- Acclimation period: ad least one 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:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 5000 and 20000 g/100mL
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: based on the physical and chemical characteristics of the test substance, a starting dose of 500 mg/kg bw was chosen. - Doses:
- 500 and 2000 mg/kg bw
- 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: twice a workday and once on weekends and public holidays
- Frequency of weighing: before application, weekly thereafter and at the end of the observation period
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 500 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: All animals died at 2000 mg/kg bw and none at 500 mg/kg bw.
- Mortality:
- - 500 mg/kg bw: 0/6
- 2000 mg/kg bw: 3/3 (1 h (2) and 2 h (1) after application) - Clinical signs:
- - 500 mg/kg bw (females): impaired general state, poor general state, dyspnoea, apathy, abdominal position, fibrillar contractions, piloerection (3 - 5 hours after application)
- 500 mg/kg bw (males): no signs of toxicity were observed
- 2000 mg/kg bw (males): poor general state, dyspnoea, apathy, staggering, twitching (0 - 1 hour after application) - Body weight:
- - 500 mg/kg bw (females): (day 0) 181 g, (day 7) 207 g, (day 13) 220 g
- 500 mg/kg bw (males): (day 0) 181 g, (day 7) 250 g, (day 13) 285 g
- 2000 mg/kg bw (males): (day 0) 189 g - Gross pathology:
- - animals that died: agonal congestive hyperaemia and slight, red discolouration of the glandular stomach,
- sacrificed animals: no abnormalities detected
Applicant's summary and conclusion
- Interpretation of results:
- harmful
- Remarks:
- Migrated information
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