Registration Dossier
Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 268-407-8 | CAS number: 68083-58-9
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 16 May 2017 to 7 June 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 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- Adopted 17th December 2001
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: "Regulation on Test Methods for Chemical Substances" Notification No. 2017-4, National Institute of Environmental Research, Republic of Korea (Mar. 14, 2017)
- Deviations:
- not specified
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- 1,3-dimethyl-3-phenylbutyl acetate
- EC Number:
- 268-407-8
- EC Name:
- 1,3-dimethyl-3-phenylbutyl acetate
- Cas Number:
- 68083-58-9
- Molecular formula:
- C14H20O2
- IUPAC Name:
- 4-methyl-4-phenylpentan-2-yl acetate
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: ORIENTBIO INC., Republic of Korea
- Age at study initiation: 8 weeks
- Weight at study initiation: 183.0-185.1 g
- Fasting period before study: yes, animals were fasted overnight, approximately 16 hours prior to dosing
- Housing: one animal/ cage
- Diet (e.g. ad libitum): Pelleted rodent chow, ad libitum
- Water (e.g. ad libitum): Public tap water in Cheongju-si was filtered and irradiated by ultraviolet light and provided ad libitum.
- Acclimation period: 3 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.1−23.2°C (Measured value)
- Humidity (%): 43.7 - 53.9 % (Measured value)
- Air changes (per hr): 10−15 clean, fresh, filtered air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle, 150 - 300 Lux
IN-LIFE DATES: From: To: 16 May - 2 June 2017
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 400 mg/mL
MAXIMUM DOSE VOLUME APPLIED: 5 mL/kg body weight
- Rationale for the selection of the starting dose: The starting dose of 2,000 mg/kg was selected due to the low expected toxicity of the test item. - Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 2 groups of 3 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All animals were observed for mortality, general condition and clinical signs at 30 minutes after dosing and at 1, 2, 4 and 6 hours after dosing on Day 0 and once daily thereafter for 14 days (Day 1−Day 14). The body weight was 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
- Other examinations performed: complete gross postmortem examinations - Statistics:
- Statistical analysis was not performed. Mean scores and values were determined.
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.
- Mortality:
- No mortalities observed at 2000 mg/kg.
- Clinical signs:
- other: Abnormal gait was observed in 2−4 animals at 2000 mg/kg at 2−6 hours after dosing, and mucous stool was observed in all animals on Day 1. These signs disappeared on Day 2.
- Gross pathology:
- No grossly visible findings were observed.
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- The test item was classified as Category 5 or Unclassified according to the GHS classification and the median lethal dose derived was: LD50 cut off ≥ 5,000 mg/kg b.w.
- Executive summary:
The toxicity of test item following a single oral dose administration to female Sprague-Dawley rats was tested according to OECD 423 and EU B.1 tris guidelines.
All animals were monitored for clinical signs and body weight changes during the 14-day observation period after administration and a gross necropsy was performed at the end of the observation period.
There were no deaths of animals at 2000 mg/kg. Abnormal gait was observed in animals at 2000 mg/kg on the day of dosing and mucous stool was observed on Day 1. And they disappeared on Day 2. No test substance-related effects were observed in body weight data or necropsy findings in any animal at 2000 mg/kg. The test item was classified as Category 5 or Unclassified according to the GHS classification and the median lethal dose derived was: LD50 cut off ≥ 5,000 mg/kg b.w.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
