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

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'-isopropylidenebis(p-phenyleneoxy)diethanol

Test material form:

liquid

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:

other: mean over 24, 48 and 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:

other: mean over 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Remarks on result:

other: no effects observed

Results 3

Irritation parameter:

iris score

Basis:

mean

Remarks:

(animal #1 and #2)

Time point:

other: mean over 24, 48 and 72 h

Score:

0

Max. score:

2

Reversibility:

other: reversibility: not applicable

Remarks on result:

other: no effects observed

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

(animal #1 and #2)

Time point:

other: mean over 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Remarks on result:

other: no effects observed

Other effects:

No other findings were observed.

Any other information on results incl. tables

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:

not irritating

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.

Executive summary:

The eye irritation potential of the test substance was determined in accordance with the OECD Guideline for Testing of Chemicals 405. 50 µl of the test substance was applied in a single application with the adjacent eye acting as a control treated with NaCl. 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.