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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
Study period:
May 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

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:
Reaction mass of 2-{[2-(2-hydroxyethoxy)ethoxy]carbonyl}benzoic acid and 2,2'-oxydiethanol
EC Number:
608-744-3
Cas Number:
32472-85-8
Molecular formula:
C12H14O6 C4H10O3
IUPAC Name:
Reaction mass of 2-{[2-(2-hydroxyethoxy)ethoxy]carbonyl}benzoic acid and 2,2'-oxydiethanol
Test material form:
liquid
Details on test material:
- Name of test material (as cited in study report): Ester PSA + DEG (Additive 1132)
- Batch no. : P2D4000711
- Physical state: liquid
- Second Exp. Date: 2013-02-16
- Currenta Sample no.: 1439
- BTS internal sample no.: 111525

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: #2, #3
Time point:
other: 60 minutes; 24 hours, 48 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
animal: #1, #2, #3
Time point:
other: 60 minutes, 24, 48, 72 hours
Score:
0
Max. score:
4
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.

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