Biphenyl-2-ol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

30 Mar 1994 - 29 Jul 1994

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Reference 2

Reference Type:

secondary source

Title:

O-Phenylphenol and its Sodium and Potassium Salts: A Toxicological Assessment

Author:

Bomhard, E. M. et al.

Year:

2002

Bibliographic source:

Crit. Rev. Toxicol. 32(6):551-626

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

(1987)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Version / remarks:

(1988)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: EPA Pesticide Assessment Guidelines, Section 81-1 (1984)

Deviations:

no

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: MAFF Acute Oral Toxicity Study (1985)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Test material

Test material information

Constituent 1

Reference substance name:

Biphenyl-2-ol

EC Number:

201-993-5

EC Name:

Biphenyl-2-ol

Cas Number:

90-43-7

Molecular formula:

C12H10O

IUPAC Name:

[1,1'-biphenyl]-2-ol

Test material form:

solid

Details on test material:

- Name of test material (as cited in study report): Dowicide 1 Antimicrobial, o-phenylphenol
- Lot/batch No.: MM931220

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 Laboratories Inc., Kingston, New York
- Age at study initiation: 51 or 52 days (animals were born on 7 Feb 1994 and dosed on 30 or 31 Mar 1994)
- Weight at study initiation: 146.4-162.8 g (males) and 92.4-109.7 g (females)
- Fasting period before study: overnight
- Housing: 2-3 animals per cage
- Diet: Purina Certified Rodent Chow #5002 (Purina Mills Inc., St. Louis, MO), 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: 30 or 31 Mar 1994 To: 13 Apr 1994

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 50%

Doses:

500, 2500, 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 or 15 days, respectively
- Frequency of observations: frequently on the day of treatment and at least once each working day thereafter
- Frequency of weighing: prestudy, on the day of treatment and on test days 2, 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

Means and standard deviations of body weights were calculated. The data were evaluated for statistical outliers by a sequential test, however, they were not routinely excluded from statistical analysis. The oral lethal dose 50 calculation was done by nonlinear interpolation.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

2 733 mg/kg bw

Based on:

test mat.

Mortality:

- 5000 mg/kg bw: 5/5 males, 5/5 females
- 2500 mg/kg bw: 2/5 males, 2/5 females
- 500 mg/kg bw: 0/5 males, 0/5 females

Clinical signs:

other: other: - 5000 mg/kg bw: laterally recumbent, decreased activity, faecal soiling, lacrimation - 2500 mg/kg bw: salivation, decreased activity, urine soiling, laterally recumbent, laboured respiration, lacrimation, chromorhinorhea, faecal soiling - 500 mg/k

Gross pathology:

- 5000 mg/kg bw: haemolysed blood in digestive tract in 2/5 males; perineal soiling and lung congestion in 1/5 males; no grossly visible lesions in 5/5 females and 2/5 males
- 2500 mg/kg bw: haemolysed blood in digestive tract in 2/4 animals that died; perineal soiling in 2/4 animals that died; fibrous adhesions between the serosa of the nonglandular portion of the stomach and the liver in 3/3 surviving males; no visible gross lesions in 3/3 surviving females
- 500 mg/kg bw: No grossly visible lesions were noted at necropsy.

The findings of adhesions from the nonglandular portion of the stomach in the 3 surviving males of the 2500 mg/kg bw dose group suggests a direct effect of the test material, since nonspecific, stress related gastric lesions usually involve the glandular portion of the stomach. This direct effect probably was secondary to erosions or ulcers of the gastric mucosa that had healed by the end of the two week observation period. The other findings, haemolysed blood in the digestive tract and perineal soiling, seen in rats that died, are considered nonspecific by the authors.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

DSD: not classified
CLP: not classified