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: 944-329-6 | CAS number: -
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 30 May - 20 Jun 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 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:
- Reaction product of o-cresol and camphene, obtained by addition, hydrogenation and distillation
- EC Number:
- 944-329-6
- Molecular formula:
- C17H28O
- IUPAC Name:
- Reaction product of o-cresol and camphene, obtained by addition, hydrogenation and distillation
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Remarks:
- (Crl:CD(SD)), SPF
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Females nulliparous and non-pregnant: not specified
- Age at study initiation: 8 weeks
- Weight at study initiation: 186.9−197.8 g
- Fasting period before study: overnight, approx. 26 h prior to dosing
- Housing: individually in stainless wire mesh cage, 260W×350D×210H (mm)
- Diet: Teklad Certified Irradiated Global 18% Protein Rodent Diet 2918C (Envigo RMS, Inc., U.S.A.), ad libitum
- Water: public tap water filtered and irradiated by ultraviolet light, ad libitum
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.9−23.6
- Humidity (%): 45.5−53.3
- 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
- Lot/batch no.: MKBZ9899V
- Concentration in vehicle: 400 mg/mL
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, 2,000 mg/kg was selected as the
starting dose for this study based on the information supplied by the sponsor. - Doses:
- 2000 mg/kg bw (step 1 and step 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 - Statistics:
- Statistical analysis was not performed. Mean scores and values were determined.
Results and discussion
Effect levelsopen allclose all
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- LD50 cut-off
- Effect level:
- >= 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed.
- Clinical signs:
- Mucous stool was observed in two animals at 2000 mg/kg bw on Day 1, and it disappeared on Day 2. Therefore, it was considered to be a test substance-related temporary change.
- Body weight:
- A decrease in body weight was observed in one animal at 2000 mg/kg bw on Day 3. Normal body weight gain was observed in this animal from Day 7. It was not considered to be a test substance-related effect because there were no clinical signs or necropsy findings of morphologic abnormalities.
- Gross pathology:
- No grossly visible findings were 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 value of ≥ 5000 mg/kg bw was found.
- Executive summary:
The purpose of this study was to assess the potential toxicity of the test substance following a single oral dose administration to female Sprague-Dawley rats and to classify the test substance under the category of GHS classification.
Two dose groups of three females were utilized as follows:
Groups 1 and 2 (Steps 1 and 2): 2,000 mg/kg of the test substance
There was no mortality.
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.
