Phenol, styrenated, epoxidized

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study according to guideline

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Test material

Test material information

Constituent 1

Reference substance name:

(1-phenylethyl)-phenyloxymethyloxirane

IUPAC Name:

(1-phenylethyl)-phenyloxymethyloxirane

Constituent 2

Reference substance name:

Phenol, styrenated, epoxidized

EC Number:

935-721-8

Molecular formula:

not applicable

IUPAC Name:

Phenol, styrenated, epoxidized

Test material form:

other: yellow liquid

Details on test material:

- Name of test material (as cited in study report): LR 600, (1-phenylethyl)-phenyloxymethyloxirane
- Substance type: organic
- Physical state: liquid

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Animals were nulliparous and non-pregnant
- Source: Harlan Laboratories UK Ltd., Oxon, UK
- Age at study initiation: 8 to 12 weeks
- Weight at study initiation: 157 g - 172 g
- Fasting period before study:
- Housing: randomly allocated to cages, in groups of three in suspended solid floor polypropylene cages furnished with woodflakes
- Diet, water: With the exception of an overnight fast immediately before dosing and for approximately three to four hours after dosing,
free access to mains drinking water and food.
- Acclimation period: at least 5d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 °C - 25°C
- Humidity (%): 30% - 70%
- Air changes (per hr): at least 15
- Photoperiod: 12 hrs dark / 12 hrs light

IN-LIFE DATES: From: To:

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

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 bodyweight at the time of dosing. Treatment of animals was sequential. Sufficient time was allowed between each group to confirm the survival of the previously dosed animals.

Doses:

2000 mg/kg bw (1.81 ml/kg bw); single oral administration

No. of animals per sex per dose:

2 groups with 3 animals each

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- The animals were observed for deaths or overt signs of toxicity ½, 1, 2 and 4 hours after dosing and subsequently once daily for fourteen days.
- Frequency of observations and weighing: prior to dosing and 7 and 14 days after treatment
- Necropsy of survivors performed: At the end of the observation period the animals were killed by cervical dislocation.
All animals were subjected to gross pathological examination. This consisted of an external examination and opening of the abdominal and
thoracic cavities for examination of major organs.

Statistics:

not applicable

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths observed

Clinical signs:

other: No signs of systemic toxicity were noted.

Gross pathology:

No abnormalities were noted at necropsy.

Any other information on results incl. tables

Table 2: Individual Bodyweights and Weekly Bodyweight Changes (excerpted from original report)

Dose Level mg/kg	Animal number and sex	Bodyweight (g) at day			Bodyweight gain (g) during week
		0	7	14	1	2
2000	1-0 Female	169	200	212	31	12
	1-1 Female	167	186	201	19	15
	1-2 Female	172	191	207	19	16
	2-0 Female	160	184	199	24	15
	2-1 Female	157	177	190	20	13
	2-2 Female	157	175	203	18	28

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: other: Globally Harmonised Classification Sytem

Conclusions:

The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2500 mg/kg bodyweight
(Globally Harmonised Classification System - Unclassified).