2-Propenoic acid, 2-methyl-, 2-(4-benzoyl-3-hydroxyphenoxy)ethyl ester

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: The study was conducted in accordance with the OECD guideline 401 (adopted 24 February 1987) and in compliance with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-(4-benzoyl-3-hydroxyphenoxy)ethyl 2-methylprop-2-enoate

Cas Number:

16613-04-0

Molecular formula:

C19 H18 O5

IUPAC Name:

2-(4-benzoyl-3-hydroxyphenoxy)ethyl 2-methylprop-2-enoate

Details on test material:

- Name of test material (as cited in study report): ULS-611
- Physical state: cream coloured solid
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Lot/batch No.: I1608X
- Storage condition of test material: ambient temperature (< 25 °C), under artificial light

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (UK) Ltd., Margate, Kent, UK
- Age at study initiation: 8-12 weeks
- Weight at study initiation: males: 216-240 g, females: 209-232 g
- Fasting period before study: overnight immediately before dosing
- Housing: by sex in groups up to 5 animals per cage
- Diet (ad libitum): Rat and Mouse Expanded Diet No. 1; Special Diets Services Limited, Witham, Essex, UK
- Water (ad libitum): yes
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21 °C
- Humidity (%): 46-57 %
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

arachis oil

Details on oral exposure:

VEHICLE (for range-finding-, and main study):
- Concentration in vehicle: 200 mg/ml
- Amount of vehicle (if gavage): 10 ml/kg bw

Doses:

2000 mg/kg bw (for range-finding-, and main study)

No. of animals per sex per dose:

Range-finding study:
1 animal per sex per dose

Main study:
5 animals per sex per dose

Control animals:

no

Details on study design:

RANGE-FINDING STUDY:
- Duration of observation period following administration: 5 days
- Frequency of observations and weighing: The animals were observed for deaths or overt signs of toxicity 0.5, 1, 2 and 4 hours after dosing and subsequently once daily for 5 days. Individual body weights were recorded on the day of dosing to allow calculation of individual treatment volumes.
- No necropsies were performed.

MAIN STUDY:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed for deaths or overt signs of toxicity 0.5, 1, 2 and 4 hours after dosing and subsequently once daily for 14 days. Individual body weights were recorded prior to dosing on day 0 and on days 7 and 14.
- At the end of the study the animals were killed by cervical dislocation.
- Necropsy of survivors performed: yes. Necropsy consisted of external examination and opening of the abdominal and thoratic cavities for examination of major organs; the appearance of any macroscopic abnormalities was recorded; no tissues were retained.

Results and discussion

Preliminary study:

In the range-finding study no deaths or clinical signs of toxicity were observed. Based on this information, a dose level of 2000 mg/kg bw was selected for the main study.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

All animals survived.

Clinical signs:

other: No signs of systemic toxicity were noted during the study.

Gross pathology:

No abnormalities were noted at necropsy.

Any other information on results incl. tables

Table 1: Individual body weight of rats after oral application of 2000 mg/kg bw ULS-611 in the main study

animal number	sex	bodyweight [g] at day
		0	7	14
3 - 0	male	227	270	305
3 - 1	male	225	288	341
3 - 2	male	216	281	343
3 - 3	male	222	287	333
3 - 4	male	240	303	351
4 - 0	female	209	231	253
4 - 1	female	219	240	254
4 - 2	female	215	233	241
4 - 3	female	210	246	253
4 - 4	female	232	248	268