2-ethoxyethyl-2-(4-(2,6-dihydro-2,6-dioxo-7-phenyl-1,5-dioxaindacen-3-yl)phenoxy)acetate

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:

1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: see attached file

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-ethoxyethyl-2-(4-(2,6-dihydro-2,6-dioxo-7-phenyl-1,5-dioxaindacen-3-yl)phenoxy)acetate

EC Number:

403-960-2

EC Name:

2-ethoxyethyl-2-(4-(2,6-dihydro-2,6-dioxo-7-phenyl-1,5-dioxaindacen-3-yl)phenoxy)acetate

Cas Number:

126877-05-2

Molecular formula:

C28H22O8

IUPAC Name:

2-ethoxyethyl 2-(4-{5,11-dioxo-12-phenyl-4,10-dioxatricyclo[7.3.0.0³,⁷]dodeca-1(12),2,6,8-tetraen-6-yl}phenoxy)acetate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

test sample reference: NBW 8809/52
Form : red powder
Moisture content : < 0.2% water
CTL sample reference number : Y04203/002/00l

Test animals

Species:

rat

Strain:

other: Wistar-derived albino rats (Alpk:APfSD strain)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Animal Breeding Unit, ICI Pharmaceuticals, Alderley Park, Macclesfield, Cheshire, UK.
- Age at study initiation: young adults
- Weight at study initiation: 211-260g for males and 171-194g for females
- Housing: suspended cages (37cm length x 32cm width x 20cm height)

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

corn oil

Doses:

single oral dose of 2 000 mg/kg

No. of animals per sex per dose:

Five male and five female

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: once within 2 hours of dosing and again between 4 and 7 hours after dosing. Observations were then made once daily, or twice daily whenever there were signs of toxicity, up to Day 15.
- Frequency of weighing: on the day before dosing (Day -1), the day of dosing (Day 1) and on Day 3, Day 6 , Day 8 and Day 15.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

None of the animals died.

Clinical signs:

other: No significant signs of toxicity were seen in any of the animals.

Any other information on results incl. tables

No significant signs of toxicity were seen in any of the animals. On Day 2 all the male rats were totally stained red. From Day 3 to the end of the study (Day 15) red staining was seen on the tail area only, although one animal remained totally stained up to Day 4. These observations wereattributed to the dye properties of the test sample. One female showed slight signs of urinary incontinence on Day 1.

No macroscopic abnormalities were detected at necropsy.

Applicant's summary and conclusion

Conclusions:

Five male and five female rats each received a single oral dose of 2000mg/kg of the Substance in corn oil. The animals were observed and
weighed during the following fourteen days.
There were no deaths and no significant signs of toxicity were seen in any of the animals. The estimated oral median lethal dose was in excess of
2000 mg/kg to both male and female rats

Executive summary:

LD 50: >2000mg/kg