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EC number: 911-593-9 | CAS number: -
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Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 7 - 28 Jun 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- adopted 17 Dec 2001
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Hex-3-en-1-yl acetate
- EC Number:
- 911-593-9
- Molecular formula:
- C8H14O2
- IUPAC Name:
- Hex-3-en-1-yl acetate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl:CD(SD), SPF
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 8 weeks
- Weight at study initiation: 185.1 - 200.1 g
- Fasting period before study: overnight, approx. 16 h prior and 4 h after dosing
- Housing: 1 animal per cage in stainless wire mesh cages (260W x 350D x 210H mm)
- Diet: Teklad Certified Irradiated Global 18% Protein Rodent Diet 2918C (Envigo RMS. Ltd., USA), ad libitum
- Water: public tap water filtered and irradiated by ultraviolet light, ad libitum
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.4 - 23.3
- Humidity (%): 44.2 - 59.7
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 400 mg/mL
- Lot/batch no.: MKBV2080V (SIGMA-ALDRICH, Co., USA)
MAXIMUM DOSE VOLUME APPLIED: 5 mL/kg bw
CLASS METHOD
- Rationale for the selection of the starting dose: Due to the low expected toxicity of the test substance 2000 mg/kg bw was selected as the starting dose. - Doses:
- 2000 mg/kg bw (Steps 1 and 2)
- No. of animals per sex per dose:
- 3 females per step
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed 30 min and 1, 2, 4 and 6 h after dosing and thereafter once daily for 14 days. Individual body weights were recorded prior to dosing on Day 0 and on Days 1, 3, 7 and on the day of necropsy, Day 14.
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50 cut-off
- Effect level:
- >= 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no mortality occurred in Step 1 and 2 at 2000 mg/kg bw in an OECD 423 study
- Mortality:
- No mortality was observed during the study period.
- Clinical signs:
- No clinical abnormalities were observed in any animal.
- Body weight:
- Normal body weight gains were observed in all animals.
- Gross pathology:
- No grossly visible evidence of morphological abnormalities was observed in any animal.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- In this acute oral toxicity study in rats a LD50 cut-off value of ≥ 5000 mg/kg bw was derived.
- Executive summary:
The acute oral toxicity of the test substance was assessed in a study according to OECD Guideline 423 and in compliance with GLP (2016).In this study, no mortality was observed at 2000 mg/kg bw (Steps 1 and 2) in female rats. Thus, a LD50 cut-off value ≥ 5000 mg/kg bw for female rats was derived.
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