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EC number: 700-993-7 | CAS number: -
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:
- 2 012
- 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
- 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
Constituent 1
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.
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