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Diss Factsheets

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:
1998
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

Constituent 1
Chemical structure
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

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