Phenol, 4,4'-(1-methylethylidene)bis[2,6-dibromo-, polymer with 2-(chloromethyl)oxirane and 4,4'-(1-methylethylidene)bis[phenol], Ph ethers

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:

2018

Report date:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Deviations:

no

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

no

Test material

Test material information

1

Reference substance name:

2,2'-[(1-methylethylidene)bis[(2,6-dibromo-4,1-phenylene)oxymethylene]]bisoxirane and 2,2'-[(1-methylethylidene)bis(4,1-phenyleneoxymethylene)]bisoxirane and their reaction products with phenol

EC Number:

600-581-6

Cas Number:

1045809-53-7

Molecular formula:

unspecified

IUPAC Name:

2,2'-[(1-methylethylidene)bis[(2,6-dibromo-4,1-phenylene)oxymethylene]]bisoxirane and 2,2'-[(1-methylethylidene)bis(4,1-phenyleneoxymethylene)]bisoxirane and their reaction products with phenol

Test material form:

liquid

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

DMSO

Details on oral exposure:

A total of five animals were therefore treated at a dose level of300 mg/kg in the study. All animals were dosed once only by gavage, using a metal cannula attached to a graduated syringe. The volume administered to each animal was calculated according to the fasted body weight at the time of dosing. Treatment of animals was sequential. Sufficient time was allowed between each dose group to confirm the survival of the previously dosed animals.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

2000 mg/kg bw: 5 female

Control animals:

no

Details on study design:

Clinical observations were made 30 minutes, 1, 2, and 4 hours after dosing and then daily for up to 14 days. Morbidity and mortality checks were made twice daily. Individual body weights were recorded on Day 0 (the day of dosing) and on Days 7 and 14. Due to a technician error the body weight at death was not performed on the animal treated at a dose level of 2000 mg/kg that was humanely killed 4 hours after dosing. At the end ofthe observation period the surviving animals were killed by cervical dislocation. All animals were subjected to gross necropsy. This consisted of an external examination and opening of the abdominal and thoracic cavities. The appearance of any macroscopic abnormalities was recorded. No tissues were retained.

Statistics:

The following computerized system was used in the study:
Delta Controls - ORCA view

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths.

Clinical signs:

other: Signs of hunched posture and lethargy were noted during the day of dosing in the initial treated animal. No other clinical observations were noted

Gross pathology:

No abnormalities were noted at necropsy.

Any other information on results incl. tables

Body weight

Dose Level mglkg	Animal Number    and Sex	Body Weight (g) at Day			Body Weight Gain (g) During Week
		0	7	14	1	2
2000	1-0 Female	176	189	200	13	11
	2-0 Female	184	197	217	13	20
	2-1 Female	195	214	213	19	-1
	2-2 Female	181	198	205	17	7
	2-3 Female	198	218	206	20	-12

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg body weight (Globally Harmonized Classification System − Unclassified).

Executive summary:

Introduction

The study was performed to assess the acute oral toxicity of the test item in the Wistar strain rat.

Methods

Following a sighting test at a dose level of 2000 mg/kg, an additional four fasted female animals were given a single oral dose of test item, as a solution in dimethyl sulfoxide, at a dose level of 2000 mg/kg body weight. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy.

Results

Mortality. There were no deaths.

Clinical Observations. Signs of hunched posture and lethargy were noted during the day of dosing in the initial treated animal. No other clinical observations were noted

Body Weight. All animals showed expected gains in body weight over the observation period except for two females who showed an expected gain in body weight during the first week but a body weight loss during the second week.

Necropsy. No abnormalities were noted at necropsy.

Conclusion

The acute oral median lethal dose (LD₅₀) of the test item in the female Wistar strain rat was estimated to be in the range of 300 - 2000 mg/kg body weight (Globally Harmonized Classification System - Category 4).