Registration Dossier

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:
30 Mar 1994 - 29 Jul 1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994
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 guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
(1987)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Version / remarks:
(1988)
Deviations:
no
Qualifier:
according to
Guideline:
other: EPA Pesticide Assessment Guidelines, Section 81-1 (1984)
Deviations:
no
Qualifier:
according to
Guideline:
other: MAFF Acute Oral Toxicity Study (1985)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: solid
Details on test material:
- Name of test material (as cited in study report): Dowicide 1 Antimicrobial, o-phenylphenol
- Physical state: solid
- Analytical purity: 99.9%
- Lot/batch No.: MM931220

Test animals

Species:
rat
Strain:
Fischer 344
Sex:
male/female
Details on test animals 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:
- 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/kg bw: No clinical findings were noted throughout the study period.
Body weight:
All surviving rats gained body weight throughout the study period.
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