4,4'-Isopropylidenediphenol, ethoxylated

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to 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 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

(partly limited documentation, e.g. no analytical characterisation of the test substance)

Principles of method if other than guideline:

Standardized test method (BASF-Test): The test substance was applied to a 2.5 x 2.5 cm application site of two white Vienna rabbits for 20 h under occlusive conditions. The skin was intact and shaved. After the application time, the skin was washed with water containing a mild detergent. Animals were observed for 5 or 6 days. Findings were recorded after 24, 48 and (for one animal) after 72 hours and at the end of the observation period. Descriptive scores of the raw data have been converted to Draize numerical scores, as recommended by the current OECD 404 Guideline.

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

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS

Source: Gaukler
Weight at study initiation: 2.86 kg (mean)
Diet: ad libitum
Water: ad libitum

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated skin of same animal

Amount / concentration applied:

1 mL

Duration of treatment / exposure:

The test substance was applied for 1 min, 5 min, 15 min and 20 h

Observation period:

5 or 6 days

Number of animals:

2 animals

Details on study design:

TEST SITE

Area of exposure: 2.5 cm x 2.5 cm
Type of wrap if used: occlusive


REMOVAL OF TEST SUBSTANCE

Washing: yes, with water containing a mild detergent (Lutrol)
Time after start of exposure: 1 min, 5 min, 15 min, 20 h


SCORING SYSTEM: Draize scoring system, as recommended by the OECD Testing Guideline 404

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Remarks:

(20 h exposure)

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.7

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 2

Irritation parameter:

erythema score

Remarks:

(20 h exposure)

Basis:

animal #2

Time point:

24/48 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 5 days

Results 3

Irritation parameter:

edema score

Remarks:

(20 h exposure)

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: no edema observed

Results 4

Irritation parameter:

edema score

Remarks:

(20 h exposure)

Basis:

animal #2

Time point:

24/48 h

Score:

0

Max. score:

4

Remarks on result:

other: no edema observed

Irritant / corrosive response data:

Treatment 20 hours: Very slight signs of irritation (erythema score 1) were observed at the 24 and 48 hour reading time point in both animals. Effects were reversible within 72 hours in animal #1, whereas 72 hours reading time point is missing in animal #2. None of the animals displayed edema.

Treatment 1 min / 5 min / 15 min: no erythema or edema observed until the end of the observation period (48 and 72 hours, respectively).

Any other information on results incl. tables

Table 1: Mean erythema score animal #1 / animal #2 after 24, 48 and 72 h (72 h reading time point is missing in animal #2)

Exposure duration	24 h	48 h	72 h	Effect reversible after
20 h	1/1	1/1	0/-	72 h / 5 d

 

Mean score, animal #1 (24 – 48 – 72 h): 0.7

Mean score, animal #2 (24 – 48 h): 1

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The mean erythema scores for both animals (24, 48 and 72 hours) were 0.7 -1, and the mean edema score for both animals (24, 48 and 72 hours) was 0. The test item is therefore classified as “non-irritant” in accordance with EU CLP 1272/2008 Regulation.

Executive summary:

In a primary dermal irritation study (equivalent to OECD guideline 404),  1 mL of the test substance was applied in an occlusive cover to the clipped skin of Vienna white rabbits (n= 2) for 20 hours followed by 5-6 days observation period. The mean erythema scores for both animals after 24, 48, and 72 hours were 0.7 - 1, and the mean oedema score for both animals after 24, 48 and 72 hours was 0. Based on the results, the test substance is not classified as a skin irritant according to the EU Classification, Labelling, and Packaging (CLP) criteria.