4,4'-Isopropylidenediphenol, ethoxylated

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1970

Report date:

1970

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

(no details about the test substance; 50 µl instead of 100 µl test substance instilled, eyes were not washed out.)

Principles of method if other than guideline:

Standardized test method (BASF-Test): 50 µL of the test substance were applied to the conjunctival sac of one eye in 2 animals. The animals were observed after 10 min, 1 and 3 h on the day of treatment and up to 8 days afterwards. Findings were recorded daily. The eyes were not washed out after 24 hours as specified in OECD Guideline 405.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

2,2'-isopropylidenebis(p-phenyleneoxy)diethanol

EC Number:

212-985-6

EC Name:

2,2'-isopropylidenebis(p-phenyleneoxy)diethanol

Cas Number:

901-44-0

Molecular formula:

C19H24O4

IUPAC Name:

2,2'-[propane-2,2-diylbis(4,1-phenyleneoxy)]diethanol

Test animals / tissue source

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS

Source: Gaukler
Weight at study initiation: 2.05 kg (mean)
Diet: ad libitum
Water: ad libitum

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: The adjacent eye served as control treated with NaCl.

Amount / concentration applied:

TEST MATERIAL

Amount(s) applied (volume or weight with unit): 50 µL

Duration of treatment / exposure:

Single application (not washed out)

Observation period (in vivo):

72 h (study was interrupted after 72 h due to reversibility of observed effects)

Number of animals or in vitro replicates:

2 animals

Details on study design:

SCORING SYSTEM: Draize scoring system, as recommended by the OECD Testing Guideline 405

TOOL USED TO ASSESS SCORE: fluorescein (at the end of exposure period)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

(animal #1 and #2)

Time point:

24/48/72 h

Score:

0.7

Max. score:

3

Reversibility:

fully reversible within: 72 h

Results 2

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

(animal #1 and #2)

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

iris score

Basis:

mean

Remarks:

(animal #1 and #2)

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

(animal #1 and #2)

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Other effects:

No other findings were observed.

Any other information on results incl. tables

Table 1: Summary results

Findings animal #1 / #2:

Time	Redness
10 min	1 / 1
1 h	1 / 1
3 h	1 / 1
24 h	1 / 1
48 h	1 / 1
72 h	0 / 0
Mean (24 – 48 – 72 h)	0.7 / 0.7

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The mean conjuctivae score was 0.7, the mean cornea score was 0, the mean iris score was 0 and the mean chemosis score was 0 (all at 24, 48 and 72 hours) The test substance is not classified as an eye irritant according to EU CLP Regulation criteria.

Executive summary:

In a primary eye irritation study (equivalent to OECD Guideline 405), the test substance was administered undiluted at a dose of 50 µL to one eye of Vienna White rabbits (n=2), the adjacent eye served as a control treated with NaCl. The treated eye of each rabbit was scored for irritation at 24- 48- and 72-hours following test item administration.  According to the study protocol, treated eyes were examined 72 hours after dosing. Irritation was scored according to OECD guideline 405 and to the criteria of Draize.

The mean conjunctivae score was 0.7, the mean cornea score was 0, the mean iris score was 0 and the mean chemosis score was 0 (all at 24, 48 and 72 hours). In this study, the test substance was not irritating to the eyes of rabbits. Thus, based on this result, the classification of the test substance as an eye irritant is not warranted according to the EU CLP Regulation 1272/2008 criteria.