p-vinylphenol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

29 August to 17 October 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

not specified

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

p-vinylphenol

EC Number:

220-103-6

EC Name:

p-vinylphenol

Cas Number:

2628-17-3

Molecular formula:

C8H8O

IUPAC Name:

p-vinylphenol

Test material form:

liquid

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Maruzen Petrochemical Co. Ltd./ Bx 7706RXD
- Expiration date of the lot/batch: no data
- Purity test date: no data

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: The test substance was put into a dark air-tight container and stored in the freezer at -30°C to -10°C
- Stability under test conditions: Stable
- Solubility and stability of the test substance in the solvent/vehicle:
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium:

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing:
- Preliminary purification step (if any):
- Final dilution of a dissolved solid, stock liquid or gel:
- Final preparation of a solid:

FORM AS APPLIED IN THE TEST (if different from that of starting material)

TYPE OF BIOCIDE/PESTICIDE FORMULATION (if applicable)

OTHER SPECIFICS:

Test animals

Species:

rat

Strain:

other: Crl:CD(SD)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Commercial laboraty animal supplier.
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8 weeks
- Weight at study initiation: 194.7g to 202.1g
- Fasting period before study: 17 to 19 hours before administration and 3 to 4 hours after administration.
- Housing: Stainless steel cages with mesh floor
- Diet: Pellets, MF, lot number 170323, Oriental yeast,ad libitum
- Water: Chlorinated water, ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 to 25°C
- Humidity (%): 40 to 70%
- Air changes (per hr): 10 to 15 air changes/hr
- Photoperiod (hrs dark / hrs light): 12 hours light, 12 hours dark.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

olive oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 10 mL/kg
- Amount of vehicle (if gavage): 10 mL
- Justification for choice of vehicle: The test substance remained in suspension homogeneously in olive oil compared to water.
- Lot/batch no. (if required): 701019
- Purity: no data

MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg

DOSAGE PREPARATION (if unusual):

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose:

Doses:

300, 2000 mg/kg

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 0, 1, 7 and 14 days.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 300 - < 2 000 mg/kg bw

Based on:

test mat.

Mortality:

At 300 mg/kg no mortalities were seen after 14 days. At 2000 mg/kg two animals were moribund and one animal was dead.

Body weight:

At 300 mg/kg no abnormalities were observed in any animals.

Gross pathology:

At 300 mg/kg no abnormalities were observed in any animals. At 2000 mg/kg, dark reddish region in the lung, distended with oily substance in the stomach, haemorrhage in subcutis of the head, blackish region of mucosa in the glandular stomach and blackish contents in the jejunum were observed in one animal.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

Under the conditions of this study, this substance should be classified as Acute toxicity; oral cat 4.