Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
May 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
This study was condusted in compliance with the principles of GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report date:
2012

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
(2002)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
2-(2-hydroxyethoxy)ethan-1-ol; 2-{[2-(2-hydroxyethoxy)ethoxy]carbonyl}benzoic acid
EC Number:
700-993-7
Molecular formula:
C12H14O6.C4H10O3
IUPAC Name:
2-(2-hydroxyethoxy)ethan-1-ol; 2-{[2-(2-hydroxyethoxy)ethoxy]carbonyl}benzoic acid
Test material form:
liquid

Test animals

Species:
rabbit
Strain:
Himalayan
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Sex: male
- Source: LPT Laboratory of Pharmacology and Toxicology GmbH & Co. KG; Branch Löhndorf; 24601 Löhndorf/Post Wankendorf; Germany
- Age at study initiation: approx. 4-5 months
- Diet and water: ad libitum
- Acclimation period: at least 20 adaption days

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: The surrounding untreated skin served as control
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
Until changes had completely subsided, however for not more than 14 days after application.
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: approximately 6 cm² on the dorso-lateral areas of the trunk of each animal
- Type of wrap if used: non-irritant tape

REMOVAL OF TEST SUBSTANCE
- At the end of the exposure time no residual test item had to be removed
- Time after start of exposure: 4 h

SCORING SYSTEM: as specified by Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
(redness and eschar formation)
Basis:
animal #1
Time point:
other: 60 minutes
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
erythema score
Remarks:
(redness and eschar formation)
Basis:
animal #1
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 h
Irritation parameter:
erythema score
Remarks:
(redness and eschar formation)
Basis:
animal #1
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 h
Irritation parameter:
erythema score
Remarks:
(redness and eschar formation)
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 h
Irritation parameter:
erythema score
Remarks:
(redness and eschar formation)
Basis:
animal #2
Time point:
other: 60 minutes
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
erythema score
Remarks:
(redness and eschar formation)
Basis:
animal #2
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
erythema score
Remarks:
(redness and eschar formation)
Basis:
animal #2
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
erythema score
Remarks:
(redness and eschar formation)
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
erythema score
Remarks:
(redness and eschar formation)
Basis:
animal #3
Time point:
other: 60 minutes
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
erythema score
Remarks:
(redness and eschar formation)
Basis:
animal #3
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
erythema score
Remarks:
(redness and eschar formation)
Basis:
animal #3
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
erythema score
Remarks:
(redness and eschar formation)
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 60 minutes
Score:
0
Max. score:
4
Reversibility:
other: no effect
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
other: no effect
Irritation parameter:
edema score
Basis:
animal #1
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
other: no effect
Irritation parameter:
edema score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
other: no effect
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 60 minutes
Score:
0
Max. score:
4
Reversibility:
other: no effect
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
other: no effect
Irritation parameter:
edema score
Basis:
animal #2
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
other: no effect
Irritation parameter:
edema score
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
other: no effect
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 60 minutes
Score:
0
Max. score:
4
Reversibility:
other: no effect
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
other: no effect
Irritation parameter:
edema score
Basis:
animal #3
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
other: no effect
Irritation parameter:
edema score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
other: no effect
Other effects:
The control areas did not show any abnormal findings.
There were no systemic intolerance reactions.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Executive summary:

A well-conducted Acute Dermal Irritation/ Corrosion test (OECD 404) was performed on rabbits with the test substance. An erythema (grade 1) was observed in all animals 60 minutes, in animal nos. 2 and 3 until 48 hours after patch removal. There were no systemic intolerance reactions.