Registration Dossier
Registration Dossier
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EC number: 271-272-8 | CAS number: 68527-63-9
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017-11-07 to 2017-11-23
- 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 guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 2001-12-17
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- Diethyl sulphate, compound with 2-(heptadec-8-enyl)-4,5-dihydro-1H-imidazole-1-ethanol (1:1)
- EC Number:
- 271-272-8
- EC Name:
- Diethyl sulphate, compound with 2-(heptadec-8-enyl)-4,5-dihydro-1H-imidazole-1-ethanol (1:1)
- Cas Number:
- 68527-63-9
- Molecular formula:
- C22H42N2O.C4H10O4S
- IUPAC Name:
- 2-{2-[(8E)-heptadec-8-en-1-yl]-4,5-dihydro-1H-imidazol-1-yl}ethan-1-ol diethyl sulfate
- Test material form:
- liquid
- Details on test material:
- Test item formulations were found to be homogeneous and stable up to 24 hour in vehicle corn oil.
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: R-127., lot 170825
- Expiration date of the lot/batch: 2019-06-19
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: InVivos Pte Ltd 9 Perahu Road, Lim Chu Kang, Singapore 718793
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 206 - 272 g
- Fasting period before study: overnight
- Housing: ndividual Ventilated Cage System
- Diet (e.g. ad libitum): Altromin Maintenance Diet #1324 ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 26 °C
- Humidity (%): 30 - 70 %
IN-LIFE DATES: From: 2017-11-09 To: max 2017-12-06
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: 300 mg/kg bw based upon OECD guideline 423- Doses:
- 300 mg/kg bw
2000 mg/kg bw - No. of animals per sex per dose:
- 6 for dose of 300 mg/kg bw
3 for dose of 2000 mg/kg bw - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observation: 30', 1,2 and 4 h, daily thereafter. Weighing: once a week, more frequently when adverse effect was observed
- Necropsy of survivors performed: yes
- Other examinations performed: body weight
Results and discussion
- Preliminary study:
- No adverse effects observed.
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50 cut-off
- Effect level:
- 500 mg/kg bw
- Based on:
- test mat.
- Mortality:
- All 3 animals were found dead 1 day after dosing of 2000 mg/kg bw.
- Gross pathology:
- No abnormalitiy was found.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- Based on CLP for acute toxicity hazard categories, the acute oral toxicity of the test item – Diethyl sulphate, compound with 2-(heptadec-8-enyl)-4,5-dihydro-1H-imidazole-1-ethanol (1:1), Lot No: 170825 is considered as Category 4; based on OECD Guideline 423, the LD50 cut-off value of the of test item - Diethyl sulphate, compound with 2-(heptadec-8-enyl)-4,5-dihydro-1H-imidazole-1-ethanol (1:1), Lot No: 170825 is 500 mg/kg body weight.
- Executive summary:
The acute oral toxicity of Diethyl sulphate, compound with 2-(heptadec-8-enyl)-4,5-dihydro-1H-imidazole-1-ethanol (1:1) was examined in a guidleine study according to OECD 423.
Based on CLP for acute toxicity hazard categories, the acute oral toxicity of the test item – Diethyl sulphate, compound with 2-(heptadec-8-enyl)-4,5-dihydro-1H-imidazole-1-ethanol (1:1), Lot No: 170825 is considered as Category 4; based on OECD Guideline 423, the LD50 cut-off value of the of test item - Diethyl sulphate, compound with 2-(heptadec-8-enyl)-4,5-dihydro-1H-imidazole-1-ethanol (1:1), Lot No: 170825 is 500 mg/kg body weight.
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