Registration Dossier
Registration Dossier
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EC number: 946-252-3 | CAS number: -
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 2017-07-12 to 2017-08-01
- 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
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- Reaction mass of hentriacontan-16-one and pentatriacontan-18-one and tritriacontan-16-one
- EC Number:
- 946-252-3
- Molecular formula:
- (C35H70O).(C33H66O).(C31H62O)
- IUPAC Name:
- Reaction mass of hentriacontan-16-one and pentatriacontan-18-one and tritriacontan-16-one
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- Batch No.: FK650468
Purity: not specific
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: Young adult animals (approximately 8-9 weeks old)
- Weight at study initiation: 151 to 174 g.
- Fasting period before study: Animals were deprived of food overnight (for a maximum of 20 hours) prior to dosing and until 3-4 hours after administration of the test item.
- Housing: group housed (up to 5 animals of the same sex and same dosing group together) in polycarbonate cages (Makrolon
MIV type; height 18 cm.) containing sterilized sawdust as bedding material equipped with water bottles.
- Diet (e.g. ad libitum): Pelleted rodent diet, ad libitum
- Water (e.g. ad libitum): Municipal tap-water, freely available
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 to 22°C
- Humidity (%): 45 to 71%
- Air changes (per hr): Ten or greater air changes per hour
- Photoperiod (hrs dark / hrs light): 12-hour light/12-hour dark cycle
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/mL
- Dose volume: 10 mL/kg body weight - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Mortality/Moribundity Checks: twice daily, in the morning and at the end of the working day.
- Postdose Observations: periodic intervals on the day of dosing (at least three times) and once daily thereafter.
- Body Weights: weighed individually on Day 1 (predose), 8 and 15.
- Necropsy of survivors performed: yes - Statistics:
- No statistical analysis was performed
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occured.
- Clinical signs:
- Hunched posture and piloerection were noted for all aniamls on Day 1.
- Body weight:
- Body weight gain was similar to that expected for the normal untreated aniamals of same age and strain.
- Gross pathology:
- No abnormalities were found.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The oral LD50 value of the test item in Wistar rat was established to exceed 2000 mg/kg bw.
- Executive summary:
The objective of this study was to determine the potential toxicity of test item, when given by oral gavage at a single dose to rats of a single sex at one or more defined doses to evaluate the potential reversibility of any findings.
The study was carried out in compliance with OECD No.423.
Test item was administered by oral gavage to two consecutive groups of three female Wistar rats at 2000 mg/kg body weight. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (Day 15).
No mortality occurred.
Hunched posture and piloerection were noted for all animals on Day 1.
The body weight gain shown by the animals over the study period was considered to be normal.
No abnormalities were found at macroscopic post mortem examination of the animals.
The oral LD50 value of test item in Wistar rats was established to exceed 2000 mg/kg body weight.
According to the OECD 423 test guideline, the LD50 cut-off value was considered to exceed 5000 mg/kg body weight.
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