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

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

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:

no guideline available

Guideline:

other: see attached report

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

Details on test material:

-Sample reference: NBW 8809/52)
- Physical state: red powder
- Moisture : <0.2 % water
- sample CTL refereence No: Y04203/002/001

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Mellor Rabbits, Chadderton Heights, Chadderton, Nr 01 dham, Greater Manchester, UK
- Weight at study initiation: 3492, 3370, 3395 and 3392g
- Housing: satinised aluminium sheet cages (60.5cm width x 49cm depth x 45.5cm height). Floor of each cage was made of perforated aluminium sheet and the door was made of polycarbonate (MAKROlON)
- Diet (e.g. ad libitum): free access to food (Labsure CRB Rabbit Diet)
- Water (e.g. ad libitum): unlimited access to water via an automatic system.
- Acclimation period: minimum of 6 days prior to the study.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 °C
- Humidity (%): 5O±1O%.
- Air changes (per hr): 20-30 air-changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours of artificial light and 12 hours of darkness.

Test system

Preparation of test site:

clipped

Vehicle:

other: paste with olive oil (1.0 ml)

Amount / concentration applied:

The test sample (approximately 5OOmg) was moistened to a paste with a small amount (l.Oml) af olive oil and was then appl ied to the test site
(approximate size 2.5cm x 2.5cm)

Duration of treatment / exposure:

4 hours

Observation period:

30-60 minutes, 1, 2 and 3 days after removal of the dressings.

Number of animals:

Four male rabbits

Details on study design:

The treated area was covered with a piece of surgical gauze (approximate size 2.5cm x 2.5cm; 8 ply) which was secured by two crossed strips of
surgical tape (approximate size 1.2cm x 8cm). This was covered by a piece of impermeable rubber sheeting (approximate size 35cm x l3cm) wrapped once around the trunk of the animal and secured with adhesive impermeable polyethylene tape (7.5cm wide).

Results and discussion

Any other information on results incl. tables

After a single four-hour application of Substance it was not possible to assess the degree of erythema owing to red staining of the test site. Histopathological examination revealed slight inflammation of the skin (consisting of inflammatory cell infiltration and acanthosis) in two animals and moderate inflammation of the skin in the other animal.

Very slight or slight oedema was observed in all animals 30-60 minutes after decontamination. These signs regressed in two animals during the subsequent observation period. One animal showed signs of moderate oedema which persisted up to three days after decontamination.

Applicant's summary and conclusion

Interpretation of results:

Category 3 (mild irritant)

Remarks:

Migrated information not Irritant in the EU

Conclusions:

In conclusions the tested Substance was a mild irritant following a single four-hour application to rabbit skin.
It is then not irritant in the EU.

Executive summary:

not irritant (EU)