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EC number: 205-055-6 | CAS number: 132-27-4
Toxicological information
Acute Toxicity: oral
Currently viewing:
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 17 Feb - 29 Jul 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Version / remarks:
- 1988
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-1 (Acute Oral Toxicity)
- Version / remarks:
- 1984
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- other: MAFF Acute Oral Toxicity Study
- Version / remarks:
- 1985
- Deviations:
- not specified
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Sodium 2-biphenylate
- EC Number:
- 205-055-6
- EC Name:
- Sodium 2-biphenylate
- Cas Number:
- 132-27-4
- Molecular formula:
- C12H9NaO
- IUPAC Name:
- sodium 2-phenylphenolate
- Details on test material:
- Batch No.: MM940104
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratoris Inc., USA
- Age at study initiation: Approximately 8 weeks
- Weight at study initiation: 167.2 - 226.1 g (males) and 120.7 - 143.2 g (females)
- Fasting period before study: Yes, animals were fasted overnight.
- Housing: 2 or 3 animals per cage were housed in animal care facilities.
- Diet: Purina Certified Rodent Chow #5002 (supplied by Purina Mills Inc., USA), ad libitum
- Water: Tap water, ad libitum
- Acclimation period: At least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 40 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 17 Feb 1994 To: 29 Jul 1994
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- methylcellulose
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 10 and 50%, respectively
DOSAGE PREPARATION: The test substance was administered as a 10 or 50% suspension in 0.5% methocel. - Doses:
- 100, 500, 1000 and 5000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed for clinical signs 30 min, 1, 4, 5 and 6 h post-dosing and thereafter at least once each working day throughout the 14-days observation period. The body weight was recorded 1 day before treatment, and thereafter on day 1, 2, 8 and 15.
- Necropsy of survivors performed: Yes, all rats submitted alive to necropsy were anesthetized by inhalation of methoxyflurane vapors and euthanized by decapitation and clamping of trachea.
Results and discussion
Effect levelsopen allclose all
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 591 mg/kg bw
- Based on:
- test mat.
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 846 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 5000 mg/kg bw: 5/5 males and 5/5 females died on day 1.
1000 mg/kg bw: 1/5 males and 1/5 females died on day 2. 2/5 males and 3/5 females died on day 5.
500 mg/kg bw: 1/3 males died on day 3 and 2/5 females died on day 5. - Clinical signs:
- other: In-life observations noted were lacrimation, salivation, chromorhinorrhea, labored respiration, decreased activity, lateral recumbency, incoordination, decreased muscle tone, mouth breathing and urine and fecal soiling in the perineal area. Clinical signs
- Gross pathology:
- The rats that died during the 2-week post-exposure observation period had treatment-related gross pathologic observations consisting of one or more of the following: hemolyzed blood in the digestive tract, perineal soiling, general visceral congestion, decreased amount of fat, pale liver, congested lungs, bloody urine and congestion, erosions and/ or ulcers, hemorrhage, or hyperemia of the stomach. The gross observations of the stomach and digestive tract were consistent with stress-induced alterations. The remaining observations in the animas that died were non-specific signs of toxicity.
There were no treatment-related gross pathologic observations in any of the surviving rats.
Any other information on results incl. tables
Table 1: Clinical signs in males
| Time post- dosing | 100 mg/kg bw | 500 mg/kg bw | 1000 mg/kg bw | 5000 mg/kg bw | |
| 30 min | survivors | 5 | 5 | 5 | 5 |
| salivation | - | 5 | 4 | 4 | |
| urine soiling | - | 2 | - | - | |
| fecal soiling | - | 1 | 1 | - | |
| decreased activity | - | - | 4 | 1 | |
| incoordinated | - | - | 3 | 1 | |
| decreased muscletone | - | - | 1 | 3 | |
| laterally recumbent | - | - | 1 | 3 | |
| mouth breathing | - | - | - | 2 | |
| 1 h | survivors | 5 | 5 | 5 | 4 |
| salivation | - | 5 | 4 | 3 | |
| urine soiling | - | 1 | - | - | |
| fecal soiling | - | 1 | - | - | |
| decreased activity | - | 1 | 4 | 1 | |
| incoordinated | - | 1 | 2 | 1 | |
| decreased muscletone | - | - | 1 | 3 | |
| laterally recumbent | - | - | 1 | 3 | |
| lacrimation | - | - | 1 | 3 | |
| 4 h | survivors | 5 | 5 | 5 | 4 |
| salivation | - | 5 | 4 | 2 | |
| urine soiling | - | 2 | 1 | 1 | |
| fecal soiling | - | 1 | - | ||
| decreased activity | - | 1 | 4 | - | |
| incoordinated | - | 1 | 3 | - | |
| decreased muscletone | - | - | - | 3 | |
| laterally recumbent | - | - | - | 4 | |
| mouth breathing | - | - | 1 | ||
| irregular respiration | - | - | - | 1 | |
| lacrimation | - | 1 | - | 4 | |
| 5 h | survivors | 5 | 5 | 5 | 1 |
| salivation | - | 5 | 4 | - | |
| urine soiling | - | 3 | - | - | |
| fecal soiling | - | 2 | - | - | |
| decreased activity | - | 1 | 4 | - | |
| incoordinated | - | 1 | 3 | - | |
| decreased muscletone | - | - | - | 1 | |
| laterally recumbent | - | - | - | 1 | |
| irregular respiration | - | - | - | 1 | |
| lacrimation | - | - | - | 1 | |
| 6 h | survivors | 5 | 5 | 5 | 0 |
| salivation | - | 5 | 4 | - | |
| urine soiling | - | 3 | 3 | - | |
| fecal soiling | 1 | 2 | - | - | |
| decreased activity | - | 1 | 4 | - | |
| incoordinated | - | 1 | 3 | - | |
| mouth breathing | - | - | 1 | - | |
| chromorhinorrhea | - | - | 1 | - | |
| lacrimation | - | 1 | - | - | |
| Day 2 | survivors | 5 | 5 | 4 | 0 |
| salivation | - | 5 | 3 | - | |
| urine soiling | - | 3 | 3 | - | |
| fecal soiling | - | 2 | - | - | |
| decreased activity | - | 1 | 3 | - | |
| incoordinated | - | 1 | 2 | - | |
| mouth breathing | - | - | 1 | - | |
| chromorhinorrhea | - | - | 1 | - | |
| lacrimation | - | 1 | 1 | - | |
| Day 5 | survivors | 5 | 4 | 2 | 0 |
| salivation | - | - | 1 | - | |
| urine soiling | - | 1 | 1 | - | |
| fecal soiling | - | 1 | - | - | |
| decreased activity | - | - | 1 | - | |
| Day 6 | survivors | 5 | 4 | 2 | 0 |
| salivation | - | - | 1 | - | |
| urine soiling | - | - | 1 | - | |
| fecal soiling | - | 1 | - | - | |
| decreased activity | - | - | 1 | - | |
| Day 7 | survivors | 5 | 4 | 2 | 0 |
| urine soiling | - | - | 1 | - | |
| fecal soiling | - | 1 | 1 | - | |
| Day 8 + 9 + 12 | survivors | 5 | 4 | 2 | 0 |
| urine soiling | - | - | 1 | - | |
| Day 13 + 14 + 15 | survivors | 5 | 4 | 2 | 0 |
| fecal soiling | - | - | 1 | - |
Table 2: Clinical signs in females
| Time post- dosing | 100 mg/kg bw | 500 mg/kg bw | 1000 mg/kg bw | 5000 mg/kg bw | |
| 30 min | survivors | 5 | 5 | 5 | 5 |
| salivation | - | 5 | 5 | 5 | |
| urine soiling | - | - | 2 | - | |
| fecal soiling | - | - | 2 | 1 | |
| decreased activity | - | 1 | 4 | 2 | |
| incoordinated | - | - | 4 | 2 | |
| decreased muscletone | - | - | 1 | 3 | |
| laterally recumbent | - | - | 1 | 3 | |
| lacrimation | - | - | 2 | 3 | |
| 1 h | survivors | 5 | 5 | 5 | 2 |
| salivation | - | 5 | 5 | 2 | |
| urine soiling | - | - | 2 | - | |
| fecal soiling | - | - | 2 | - | |
| decreased activity | - | 1 | 4 | - | |
| incoordinated | - | - | 4 | - | |
| decreased muscletone | - | - | 1 | 2 | |
| laterally recumbent | - | - | 1 | 1 | |
| lacrimation | - | 1 | 1 | 1 | |
| 4 h | survivors | 5 | 5 | 5 | 1 |
| salivation | - | 5 | 5 | 1 | |
| urine soiling | - | 3 | 2 | - | |
| fecal soiling | - | - | 2 | - | |
| decreased activity | - | 1 | 4 | - | |
| incoordinated | - | 1 | 4 | - | |
| decreased muscletone | - | - | 1 | 1 | |
| laterally recumbent | - | - | 1 | 1 | |
| lacrimation | - | 2 | 3 | 1 | |
| 5 h | survivors | 5 | 5 | 5 | 1 |
| salivation | - | 5 | 5 | 1 | |
| urine soiling | - | 3 | 2 | - | |
| fecal soiling | - | - | 2 | - | |
| decreased activity | - | 1 | 4 | - | |
| incoordinated | - | 1 | 4 | - | |
| decreased muscletone | - | - | 1 | 1 | |
| laterally recumbent | - | - | 1 | 1 | |
| chromorhinorrhea | - | 1 | - | - | |
| lacrimation | - | 2 | 2 | 1 | |
| 6 h | survivors | 5 | 5 | 5 | 1 |
| salivation | - | 4 | 5 | 1 | |
| urine soiling | - | 4 | 2 | - | |
| fecal soiling | - | - | 2 | - | |
| decreased activity | - | 3 | 4 | - | |
| incoordinated | - | 3 | 4 | - | |
| decreased muscletone | - | - | 1 | 1 | |
| chromorhinorrhea | - | 1 | - | - | |
| lacrimation | - | 1 | 2 | 1 | |
| Day 2 | survivors | 5 | 5 | 4 | 0 |
| salivation | - | 4 | 4 | - | |
| urine soiling | - | 4 | 4 | - | |
| decreased activity | - | 3 | 4 | - | |
| incoordinated | - | 2 | 2 | - | |
| chromorhinorrhea | - | 2 | 1 | - | |
| lacrimation | - | 2 | 1 | - | |
| Day 5 + 6 | survivors | 5 | 3 | 1 | 0 |
| salivation | - | 2 | 1 | - | |
| urine soiling | - | 2 | 1 | - | |
| incoordinated | - | - | - | - | |
| decreased activity | - | 1 | |||
| Day 7 + 8 | survivors | 5 | 3 | 1 | 0 |
| decreased activity | - | 1 | - | - | |
| salivation | - | 2 | - | - | |
| urine soiling | - | 2 | 1 | - | |
| fecal soiling | - | 1 | - | ||
| Day 9 | survivors | 5 | 3 | 1 | 0 |
| salivation | - | 2 | - | - | |
| fecal soiling | - | 1 | - | - | |
| decreased activity | - | 1 | - | - | |
| urine soiling | - | 1 | 1 | ||
| Day 12 | survivors | 5 | 3 | 1 | 0 |
| salivation | - | 2 | - | - | |
| fecal soiling | - | 1 | - | - | |
| decreased activity | - | 1 | - | - | |
| chromorhinorrhea | - | 1 | - | - | |
| labored respiration | - | 1 | - | - | |
| urine soiling | - | 1 | - | - | |
| Day 13 | survivors | 5 | 3 | 1 | 0 |
| salivation | - | 1 | - | - | |
| fecal soiling | - | 1 | - | - | |
| decreased activity | - | 1 | - | - | |
| chromorhinorrhea | - | 1 | - | - | |
| labored respiration | - | 1 | - | - | |
| urine soiling | - | 1 | - | - | |
| Day 14 | survivors | 5 | 3 | 1 | 0 |
| salivation | - | 1 | - | - | |
| fecal soiling | - | 1 | - | - | |
| decreased activity | - | 1 | - | - | |
| labored respiration | - | 1 | - | - | |
| urine soiling | - | 1 | - | - | |
| Day 15 | survivors | 5 | 3 | 1 | 0 |
| salivation | - | 1 | - | - | |
| fecal soiling | - | 1 | - | - | |
| decreased activity | - | 1 | - | - | |
| labored respiration | - | 1 | - | - | |
| thin | - | 1 | - | - | |
| urine soiling | - | 1 | - | - |
Applicant's summary and conclusion
- Interpretation of results:
- other: Acute oral 4, H302 according to Regulation (EC) No. 1272/2008
- Conclusions:
- CLP: Acute oral 4, H302
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