Registration Dossier
Registration Dossier
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EC number: 822-765-7 | CAS number: 1817777-04-0
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- December 2016 to April 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- no
Test material
- Reference substance name:
- 2-Chloro-8-((S)-1-cyclopropyl-ethyl)-5,8-dihydro-pteridine-6,7-dione
- EC Number:
- 822-765-7
- Cas Number:
- 1817777-04-0
- Molecular formula:
- C11H11ClN4O2
- IUPAC Name:
- 2-Chloro-8-((S)-1-cyclopropyl-ethyl)-5,8-dihydro-pteridine-6,7-dione
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl:WI(Han)
- Sex:
- female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- methylcellulose
- Doses:
- 300 and 2000 mg/kg
- No. of animals per sex per dose:
- 5 female:300 mg/kg
5 female: 2000 mg/kg - Control animals:
- not specified
Results and discussion
- Preliminary study:
- 1 female: 300 mg/kg
1 female: 2000 mg/kg
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Four animals dosed at 2000 mg/kg were humanely killed due to the severity of clinical signs.
No deaths were seen at 300 mg/kg. - Clinical signs:
- other: Clinical signs noted in animals dosed at 300 mg/kg were confined to hunched posture which was noted in one animal from 3 hours after dosing, lasting up to Day 2. Piloerection, decreased activity, lethargy, hunched posture, ptosis, palpebral closure, decre
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The test material was classified as Category 4 in respect of its acute oral toxicity according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).
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