1,1'-isopropylidenebis[4-(allyloxy)-3,5-dibromobenzene]

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

November 1981

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

significant methodological deficiencies

Remarks:

eye rinsed after 30sec instead of 1 hour and not all the required data are given in the test report.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

The eyes of the tested animals were rinsed after 30 seconds instead of 1 hour.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1,1'-isopropylidenebis[4-(allyloxy)-3,5-dibromobenzene]

EC Number:

246-850-8

EC Name:

1,1'-isopropylidenebis[4-(allyloxy)-3,5-dibromobenzene]

Cas Number:

25327-89-3

Molecular formula:

C21H20Br4O2

IUPAC Name:

1,1'-isopropylidenebis[4-(allyloxy)-3,5-dibromobenzene]

Test material form:

solid: particulate/powder

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Each rabbit was sexed, weighted and ear tagged with a unique animal numer (weight range: 1.95 kg to 2.55kg). The rabbts were quarantined and acclimated to laboratory conditions for 12 days prior to initiation of the study. The rabbits were individually housed in stain-less steel wire-bottomed cages suspended above the droppings. Animals were observed twice daily during the quarantine period.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

100mg applied to the right eye - 6 not rinsed and 3 rinsed after 30 seconds

Duration of treatment / exposure:

Single dose

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

9 animals (4 males and 5 females)

Details on study design:

Grading for irrittation and injury were made at 24, 48 and 72 hours and at 4 and 7 days, using the standard scoring system of Draize. Fluoroscein examinations were used to facilitate evaluation of potential corneal damage.

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 24/48/72 h - 4d - 7d

Score:

>= 0 - <= 4

Max. score:

4

Reversibility:

fully reversible within: 72h for rinsed animals - 7 days for not rinsed animals

Irritant / corrosive response data:

The primary irritation index was calculated to be 4.0 for the not rinsed test animals and 1.33 for the rinsed test animals.

Other effects:

no signs of systemic toxicity and no deaths occurred

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The substance is not classified as irritant for eyes.

Executive summary:

The primary eye irritation index was calculated to be 1.33 for the rinsed test animals and all the effects were completely reversible after 72h, therefore the substance is not classified as irritant for eyes.