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Toxicological information

Skin irritation / corrosion

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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:
other: Study was conducted using OECD Testing Guideline 404, but was not conducted according to GLP standards.

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

Constituent 1
Chemical structure
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-(4-{2-[4-(2-hydroxyethoxy)phenyl]propan-2-yl}phenoxy)ethan-1-ol
Test material form:
liquid

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

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
(20 h exposure)
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
erythema score
Remarks:
(20 h exposure)
Basis:
animal #2
Time point:
other: mean over 24 and 48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 5 days
Irritation parameter:
edema score
Remarks:
(20 h exposure)
Basis:
animal #1
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 edema observed
Irritation parameter:
edema score
Remarks:
(20 h exposure)
Basis:
animal #2
Time point:
other: mean over 24 and 48 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Remarks on result:
other: no edema observed
Irritant / corrosive response data:
Treatment 20 hours: Very slight signs of irritation (erythemy 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 oedema.

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

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:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
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 substance is not classified as a skin irritant according to EU CLP.
Executive summary:

The skin irritation potential of the test substance was determined in accordance with the OECD Guideline for Testing of Chemicals 404. 1 ml (g) of the test substance was applied in an occlusive cover to the clipped skin of Vienna white rabbits. 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 substance is not classified as a skin irritant according to the EU Classification, Labelling and Packaging (CLP) criteria.