Benzoic acid, 4-[4-(2-oxiranyl)butoxy]-, 4-methoxyphenyl ester

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

26 September 2000 - 12 October 2000

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was performed according to OECD guideline and GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

435-360-1

EC Name:

-

Cas Number:

144447-11-0

Molecular formula:

C20H22O5

IUPAC Name:

4-methoxyphenyl 4-[4-(oxiran-2-yl)butoxy]benzoate

Details on test material:

Identification: Epoxyhexmes
Trade Name: Epoxyhexmes
Chemical name: 4-methoxyphenyl-4(5,6-epoxyhexyloxy)benzoate
CAS-No: 144447-11-0
Description: White crystalline solid
Batch: RTC9811501003
Purity: 97.3%
Test substance storage: At room temperature in the dark
Stability under storage conditions: Stable
Expiry date: 31 December 2001

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: approx. 7 weeks old
- Weight at study initiation: mean females 179g, mean males 269g
- Fasting period before study: Food was withheld overnight (for a maximum of 20 hours) prior to dosing until approximately 3-4 hours after administration of the test substance.
- Housing: Group housing of 3 animals per sex per cage in labelled polycarbonate cages containing purified sawdust as bedding material (SAWI, Jelu Werk, Rosenberg, Germany). Certificates of analysis were examined and then retained in the NOTOX archives.
- Diet (e.g. ad libitum): Free access to standard pelleted laboratory animal diet (from Altromin (code VRF 1), Lage, Germany). Certificates of analysis were examined and then retained in the NOTOX archives.
- Water (e.g. ad libitum): Free access to tap-water. Certificates of quarterly analysis were examined and then retained in the NOTOX archives.
- Acclimation period: Acclimatisation period was at least 5 days before start of treatment under laboratory conditions.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21±3
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: 26 September 2000 - 12 October 2000

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

propylene glycol

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 2000 mg/kg bw at 10 ml/kg
- Amount of vehicle (if gavage): max. 10 ml/kg
- Justification for choice of vehicle: none
- Lot/batch no. (if required): none
- Purity: none

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: none

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: mortality/viability was checked twice daily
- Necropsy of survivors performed: yes
- Other examinations performed:
clinical signs: At periodic intervals on the day of dosing (day 1) and once daily thereafter, until day 15.
body weight: Days 1 (pre-administration), 8 and 15.

Statistics:

No statistical analysis was performed

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No mortality occurred.

Clinical signs:

other: On day 1: lethargy and hyperthermia were noted in al/ males and lethargy and/or abnormal gait were noted in all females.

Gross pathology:

Macroscopic post mortem examination revealed no abnormalities in any of the animals.

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Remarks:

Migrated information

Conclusions:

The oral LD50 value of the substance in Wistar rats was established to exceed 2000 mg/kg body weight.

Executive summary:

The substance was administered by oral gavage to three Wistar rats of each sex at 2000 mg/kg body weight. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (day 15). No mortality occurred. On day 1, lethargy and hyperthermia were noted in all males and lethargy and/or abnormal gait were noted in all females.

The body weight gain shown by the animals over the study period was considered to be normal. Macroscopic post mortem examination revealed no abnormalities in any of the animals.

The oral LD50 value of the substance in Wistar rats was established to exceed 2000 mg/kg body weight.