Biphenyl-2-ol, ethoxylated, esters with acrylic acid

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Deviations:

yes

Remarks:

two doses were used

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: National Institute of Environmental Research Notification No. 2006-29 'Regulations Regarding the Designation of Chemical Hazard Testing Institutes', Annex 5 Test Guidelines for Chemicals (December 19, 2006).

Principles of method if other than guideline:

acut toxicity study with one oral exposure, two doses 300 and 2000 mg/kg.

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Biphenyl-2-ol, ethoxylated, esters with acrylic acid

EC Number:

500-247-9

EC Name:

Biphenyl-2-ol, ethoxylated, esters with acrylic acid

Cas Number:

72009-86-0

Molecular formula:

C17H16O3 (OPPEA) - C19H20O4 (OPP(EO)2A)

IUPAC Name:

2-(2-phenylphenoxy)ethyl prop-2-enoate

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: Ethoxylated-o-phenyl phenol acrylate, Cas no. 72009-86-0, Lot no. 71016M95
- Expiration date of the lot/batch:
- Purity test date: November 08, 2007
- Purity: 97,4 %
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature
- Stability under test conditions: NA
- Solubility and stability of the test substance in the solvent/vehicle: NA
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: NA


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

OTHER SPECIFICS: guideline.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Specific Pathogen Free (SPF) Rats [Crl:CD(SD)]

- Females (if applicable) nulliparous and non-pregnant: Not specified
- Age at study initiation: 9 weeks old
- Weight at study initiation: 166.9 – 196.1 g
- Fasting period before study: Overnight
- Housing: 3 animals per cage
- Diet (e.g. ad libitum): yes
- Water (e.g. ad libitum): yes
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 oC
- Humidity (%): 50 +/- 10 %
- Air changes (per hr): 10-20 per hour
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: To: January 3rd – February 1st

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: Corn oil, Sigma-Aldrich Co.
- Amount of vehicle (if gavage):10mL/kg, including test item.
- Justification for choice of vehicle: Oral administration is the potential clinical route for humans, Vehicle is non-toxic at the level used in this study
- Lot/batch no. (if required): 065K0077
- Purity: NA

MAXIMUM DOSE VOLUME APPLIED:

DOSAGE PREPARATION (if unusual):

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Since there were no toxicity, information on animals, 300 mg/kg was selected according to the Class method test

Doses:

- 300 mg/kg (step 1)
- 300 mg/kg (step 2)
- 2000 mg/kg (step 3)
- 2000 mg/kg (step 4)

No. of animals per sex per dose:

3 animals per dose per step

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days:
Clinical signs and mortality were observed at 0.5, 1, 2, 3, and 4 hours hours after administration on the dosing date (Day 1) and once each day on the following day (Day 2) to Day 15.

- Frequency of observations and weighing right before initiation of administration (Day 1 1) and Days 2, 4, 8, and 15.

- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other: All organs were examined for abnormalities.

Statistics:

Not specified

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 - <= 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed

Clinical signs:

other: In 3rd step at dose level of 2000 mg/kg, lateral position, subdued behavior, irregular respiration and lacrimation were observed in 3, 3, 2, and 3 animals respectively on dosing date. In 4th step at equal dose level of 2000 mg/kg,

Gross pathology:

No test item related pathological effects.

Other findings:

No other effect observed.

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

The acute toxicity of Ethoxylated-o-phenylphenol acrylate was tested in a single dose acute toxicity test, comparable to OECD Guideline 423. No test item related mortality was observed at the highest tested dose level 2000 mg/kg.

Executive summary:

The acute toxicity of Ethoxylated-o-phenylphenol acrylate was tested in a single dose acute toxicity test, comparable to OECD Guideline 423. The acute toxicity class method were used in female SD rats with dose level 300 and 2000 mg/kg. The test item was giving orally with corn oil as vehicle in a total volume of 10 ml/kg bw, which is acceptable according to the OECD guideline. Several clinical signs were observed, such as prone position, lateral position, subdued behavior, irregular respiration, and lacrimation. However, the symptoms were transient and only present at the day of treatment.

No mortality was observed at any of the doses, therefore the acute oral LD50 is above 2000mg/kg.