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: 436-120-9 | CAS number: 99627-05-1
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- May 26, 2000 - September 28, 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- March 22, 1996
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- September 30, 1996
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- 3,4,5-trifluorophenol
- EC Number:
- 436-120-9
- EC Name:
- 3,4,5-trifluorophenol
- Cas Number:
- 99627-05-1
- Molecular formula:
- C6H3F3O
- IUPAC Name:
- 3,4,5-trifluorophenol
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: HsdCpb: WU
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: F. Winkelmann, 33178 Borchen
- Age at study initiation: about 6 to 8 weeks
- Weight at study initiation: 172 (range from 159 to 181) g
- Fasting period before study: Diet was withheld from about 17 hours before dosing up to 4 hours after treatment.
- Housing: separately in Makrolon cages type HI with a shelter
- Diet: ad libitum, LONG LIFE for mice and rats 9439, Eberle Nafag)
- Water: ad libitum, tap water
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 to 28
- Humidity (%): 50 to 66
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Methocef K4M Premium solution
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 1.25, 10, 100 g/L
MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg
- Doses:
- 25, 200, 2000 mg/kg bw
- No. of animals per sex per dose:
- 3 (see table1)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The behavior and general condition of all rats were monitored for at least 6 hours after the administration and then checked daily. All animals were weighed before treatment and on days 2, 4, 6, 8, 11, 13, and 15 of the experimental part.
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- >= 200 - <= 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- All animals of the highest dose died within a few minutes after administration.
- Clinical signs:
- Signs of toxicity were seen from 1 to 15 minutes up to day 3 after administration.
2000 mg/kg bw (f): lateral position, motor excitation, and dyspnea.
200 mg/kg bw (m + f): abdominal and dorsal position, lococmotor disturbance, and dyspnea.
25 mg/kg bw(m): locomotor disturbance was the only symptom. - Body weight:
- Body weight development of the surviving rats was inconspicuous.
- Gross pathology:
- At pathology all rats which died showed mild local changes in the gastro intestinal tract. All rats which were sacrificed at the end of the study showed no macroscopic abnormalities.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- According to the results of this study the LD50 value is expected between 200 - 2000 mg/kg bw.
- Executive summary:
A study according OECD TG 423 (Acute Class Method) was performed to determine the acute oral toxicity of the test item. The test material was administered by oral gavage using doses of 25, 200, and 2000 mg/kg body weight. Directly before the administration the test material was prepared with aqueous Methocel® K4M Premium solution as vehicle.
Signs of toxicity were seen from 1 to 15 minutes up to day 3 after administration. In females of the 2000 mg/kg be dose group lateral position, motor excitation, and dyspnea was reported.
In all animals of the 200 mg/kg bw dose group abdominal and dorsal position, locomotor disturbance, and dyspnea was detected. In the 25 mg/kg bw dose group males showed locomotor disturbance.
All animals of the highest dose died within a few minutes after administration. Body weight development of the surviving rats was inconspicuous.
At pathology all rats which died showed mild local changes in the gastro intestinal tract. All rats which were sacrificed at the end of the study showed no macroscopic abnormalities.
According to the results of this study the LD50 value is expected between 200 - 2000 mg/kg bw.
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.
