ethyl 2-(4-phenoxyphenyl)lactate

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:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

429-220-9

EC Name:

-

Cas Number:

132584-17-9

Molecular formula:

C17 H18 O4

IUPAC Name:

ethyl 2-hydroxy-2-(4-phenoxyphenyl)propanoate

Test material form:

liquid

Specific details on test material used for the study:

Purity: 73.5%
Batch IN-JG303-7

Test animals

Species:

rat

Strain:

other: Crl:CD (SD)BR

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories
- Females (if applicable) nulliparous and non-pregnant: [yes/no] yes
- Age at study initiation: males were 56 or 57 days old; females were 78 days old
- Weight at study initiation: not reported
- Fasting period before study: yes
- Housing: singly in suspended, stainless steel, wire-mesh cages
- Diet (e.g. ad libitum): PMI Nutrition International, Inc. Certified Rodent LabDiet® 5002 ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23°C ± 1°C
- Humidity (%): 50% ± 10%
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12-hour light/12-hour dark cycle

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

1000 and 2000 mg/kg

No. of animals per sex per dose:

5/sex/dose

Control animals:

no

Details on study design:

Observations for mortality and signs of illness, injury, or abnormal behavior were made daily throughout the study. Observations for clinical signs of toxicity were made within 30 minutes of dosing and then 4 times within 4 hours of dosing, twice a day on test days 2, 3, and 4, and daily throughout the remainder of the study (weekends excluded unless warranted by the condition of the rats). The male and female rats dosed at 2000 mg/kg were inadvertently observed once on test day 4. Surviving rats were weighed daily throughout the study (weekends excluded unless warranted by the condition of the rats). The weight of the carcass of rats found dead was also recorded. Rats found dead during the study or euthanized by design at the end of the 15-day test period were submitted for gross pathological examination.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 2
Male: 1000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0

Clinical signs:

other: Signs of toxicity related to dose levels: Only two rats showed significant dose related effects, both males at 2000 mg/kg. One was found dead on day 3 with no abnormalities noted and the second died day 4 following an observatiion of hunched posture,

Gross pathology:

Effects on organs:
There were no major effects in organs. One of the animals
that died had some small areas of discolouration on the
liver.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Oral LD50 (male/female rats) > 2000 mg/kg