Registration Dossier
Registration Dossier
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EC number: 405-800-7 | CAS number: 27955-94-8
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP study in accordance with relevant guideline; selected as the key study because the information provided for the hazard endpoint is sufficient for the purpose of classification and labelling and/or risk assessment.
Data source
Reference
- Reference Type:
- other: reference to body responsible for the test
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- no
- Remarks:
- Study was conducted according to guideline in effect at time of study.
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 4,4',4''-(ethan-1,1,1-triyl)triphenol
- EC Number:
- 405-800-7
- EC Name:
- 4,4',4''-(ethan-1,1,1-triyl)triphenol
- Cas Number:
- 27955-94-8
- Molecular formula:
- C20H18O3
- IUPAC Name:
- 4,4',4''-(ethan-1,1,1-triyl)triphenol
- Details on test material:
- - Purity: 99%
- The test substance in 1% aqueous methylcellulose
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl:CD® (SD) BR VAF plus
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 4-6 weeks
- Weight at study initiation: 98-116 g
- Fasting period before study: Not reported.
- Housing: Up to 5 rats of the same sex in groups, within metal cages with wire mesh floors
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-23
- Humidity (%): mean value was 55%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 1 % aqueous methylcellulose
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 50%
- Amount of vehicle (if gavage): 5.0 mL/kg body weight.
- Justification for choice of vehicle: Not reported/
MAXIMUM DOSE VOLUME APPLIED: 10.0 mL/kg body weight
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: A preliminary test was carried out using a dose of 2.5 g/kg. The rationale was not reported. - Doses:
- 2.5 g/kg (preliminary test)
5.0 g/kg (main study) - No. of animals per sex per dose:
- - preliminary test: 2/sex/dose
- main studY: 5/sex/dose - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: (preliminary study) 5 days; (main study) 14 days.
- Frequency of observations and weighing: observation soon after dosing, at frequent intervals for the remainder of Day 1, and twice daily for the rest of the observation period. Rats were weighed on Days 1 (day of dosing), 8, and 15 (main study).
- Necropsy of survivors performed: Yes (main study). - Statistics:
- Male: 5000 mg/Kg bw; Number of animals: 5; Number of deaths: 0
Female: 5000 mg/Kg bw; Number of animals: 5; Number of deaths: 0
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Mortality:
- Male: 5000 mg/Kg bw; Number of animals: 5; Number of deaths: 0
Female: 5000 mg/Kg bw; Number of animals: 5; Number of deaths: 0 - Clinical signs:
- Signs of toxicity related to dose levels:
The only effect seen was piloerection during the first day post-dose - Body weight:
- A slight low body weight gain was recorded for 1 male rat on Day 8. All other rats achieved anticipated body weight gains throughout the study.
- Gross pathology:
- No treatment-related macroscopic findings were observed.
Any other information on results incl. tables
Male: 5000 mg/Kg bw; Number of animals: 5; Number of deaths: 0 Female: 5000 mg/Kg bw; Number of animals: 5; Number of deaths: 0
Applicant's summary and conclusion
- Interpretation of results:
- relatively harmless
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The study and the conclusions which are drawn from it fulfil the quality criteria (validity, reliability, repeatability). No specimen deaths were recorded. LD50 >5000 mg/kg.
- Executive summary:
Test substance suspended in 1% aqueous methylcellulose was administed as a single 5000 mg/kg oral dose to 5 male/5 femal rats. The rats were observed for 14 days. There were no deaths during the observation period. One male rat had abnormal (lower than average) body weight gain. Gross necropsy findings were normal. The acute oral LD50 was greater than 5000 mg/kg.
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