Registration Dossier
Registration Dossier
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EC number: 214-772-3 | CAS number: 1193-24-4
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1995-07-24 to 1995-08-14
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study according to OECD guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 6-hydroxy-1-H-pyrimidin-4-one
- IUPAC Name:
- 6-hydroxy-1-H-pyrimidin-4-one
- Reference substance name:
- 6-hydroxy-1H-pyrimidin-4-one
- EC Number:
- 214-772-3
- EC Name:
- 6-hydroxy-1H-pyrimidin-4-one
- Cas Number:
- 1193-24-4
- Molecular formula:
- C4H4N2O2
- IUPAC Name:
- 6-hydroxypyrimidin-4(3H)-one
- Details on test material:
- - Substance type: pure active substance
- Physical state: solid, homogeneous brownish-yellow powder
- Impurities (identity and concentrations): water 1.78%
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- other: Cpb/Win:WU (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: young adult
- Weight at study initiation: males 134 - 205 g, females 121 - 141 g
- Fasting period before study: 16 hours
- Housing: conventional, sexes separated, 5 animals/Macrolon cage type III
- Diet: ad libitum, Ssniff R 10 Alleindiaet fuer Ratten
- Water: communal drinking water ad libitum
- Acclimation period: > 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12
IN-LIFE DATES: From: 1995-07-24 To: 1995-08-14
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 2 g / 10 cm3
- Amount of vehicle (if gavage): 10 cm3 / kg body weight
- Lot/batch no. : Maiskeimoel MEH 56 - Doses:
- 2000 mg/kg body weight
- 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: 0.5, 1, 2, 3 4, 5, 6 hours after application, then daily; weighing: days 0, 7, 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- None (limit test)
Results and discussion
- Preliminary study:
- Two male and two female animals were treated with 2000 mg/kg bw , as a preliminary test. Since no mortality was observed after 24 hours, three more males and females were treated with the same dose. The results were pooled and reported for the whole group of 5 animals per sex: No mortalities occurred.
Effect levelsopen allclose all
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- LD0
- Effect level:
- >= 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- male
- Dose descriptor:
- LD0
- Effect level:
- >= 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- None observed
- Clinical signs:
- other: None in females. None in 4/5 males. Abnormal gait, crouched position, decrease of motility, ruffled fur, staggering, and coordination disturbance (onset after 24 hours) in one male. In this animal, all symptoms (except crouched position) lasted until day
- Gross pathology:
- No signs of macroscopically detectable organ changes
- Other findings:
- - Other observations: Orange discoloration of urine (color of test substance, observed in bedding)
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The study report is adequate and reliable for risk assessment, classification and labeling.
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