Registration Dossier
Registration Dossier
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EC number: 203-309-0 | CAS number: 105-56-6
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Secondary literature
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- SIDS INITIAL ASSESSMENT REPORT - Cyanoacetates
- Author:
- OECD
- Year:
- 2 006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Ethyl cyanoacetate
- EC Number:
- 203-309-0
- EC Name:
- Ethyl cyanoacetate
- Cas Number:
- 105-56-6
- Molecular formula:
- C5H7NO2
- IUPAC Name:
- ethyl 2-cyanoacetate
Constituent 1
Test animals
- Species:
- rat
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Duration of treatment / exposure:
- 90 days
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0; 100; 300; 1000 mg/kg bw/day
Basis:
- No. of animals per sex per dose:
- 10
Examinations
- Observations and examinations performed and frequency:
- - clinical signs, eye affections, body weight food consumption, FOB
- clinical chemistry and hematological examinations were performed at the end of the treatmentand recovery periods respectively
- additional examinations: determination of estrus cycle length by vaginal smear of all surviving females 14 days prior to the completion of the treatment adn recovery periods, respectively; sperm motility and epididymal sperm counts were determined of all males at the terminal sacrifice.
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- effects observed, treatment-related
- Clinical biochemistry findings:
- effects observed, treatment-related
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- effects observed, treatment-related
- Details on results:
- CLINICAL SIGNS AND MORTALITY
No mortalities occured.
HAEMATOLOGY
1000 mg/kg bw: reduction of haemoglobin (female)
300 mg/kg bw: reduction of haemoglobin (female)
URINALYSIS
1000 mg/kg bw: increased urine volume
HISTOPATHOLOGY: NON-NEOPLASTIC
1000 mg/kg bw: reversible chronic peribiliary inflammation in the liver (male), reversible vacuolization in the zona fasciculata of the adrenals (males); decreased percentage of motile sperms and sperm count in the epididymides (males); these changes were not accompanied by significant reductions in testicular or epididymal weights, or any histopathological findings in these organs.
Effect levels
open allclose all
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
No effects were observed on the estrus cycle of the female rats.
Sperm analysis in males revealed a statistically significant decrease in the percentage of motile sperms (ca. 18% decrease) and progressively motile sperms (ca. 20%) in the high dose group compared to concurrent controls, although the reduction was less pronounced than after the treatment period. The number of homogenization resistant, detergent resistant sperms per cauda epididymis or per gram epididymis was significantly reduced in the high dose group animals. In the recovery group animals the reduction was not accompanied by reductions in testicular or epididymal weights or any histopathological findings in testes or epididymis.
Applicant's summary and conclusion
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