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EC number: 259-134-5 | CAS number: 54381-16-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From Feb. 20, 1979 to Feb. 23, 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given, comparable to scientific standards/principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The study was performed to determine the skin irritation potential of test substance on the rabbit skin. The aqueous slurry of test substance was applied to the shaved skin and the irritation potential was determined.
- GLP compliance:
- no
Test material
- Reference substance name:
- (p-ammoniophenyl)bis(2-hydroxyethyl)ammonium sulphate
- EC Number:
- 259-134-5
- EC Name:
- (p-ammoniophenyl)bis(2-hydroxyethyl)ammonium sulphate
- Cas Number:
- 54381-16-7
- Molecular formula:
- C10H16N2O2.H2O4S
- IUPAC Name:
- (p-ammoniophenyl)bis(2-hydroxyethyl)ammonium sulphate
- Reference substance name:
- N,N-bis(2-hydroxyethyl)-p-phenylenediamine sulfate
- IUPAC Name:
- N,N-bis(2-hydroxyethyl)-p-phenylenediamine sulfate
- Details on test material:
- - Name of test material: N,N-Bis(2-Hydroxyethyl)-p-phenylenediamine sulfate
No other information on the test substance was provided in the study report.
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- EXPERIMENT INITIATION DATE: Feb. 20, 1979
EXPERIMENT COMPLETION DATE: Feb 23, 1979
No details on test animals and environmental conditions were provided in the study report.
Test system
- Type of coverage:
- not specified
- Preparation of test site:
- other: shaved intact and abraded skin
- Vehicle:
- other: aqueous slurry of test substance
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied : 500 mg (aqueous slurry)
- Concentration: Undiluted - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 24 and 72 h after treatment
- Number of animals:
- Shaved intact skin: 6 animals (4 female and 2 male)
Shaved abraded skin: 6 animals (4 female and 2 male) - Details on study design:
- TEST SITE: The test site was shaved. No other information on test site was provided in the study report.
REMOVAL OF TEST SUBSTANCE: No details on the removal of test substance are provided in the study report.
SCORING SYSTEM: The irritation index used to classify the test substance was as follows:
0-2………………………………Mild irritant
2.1-4.9………………………..Moderate irritant
5-8……………………………… Severe (primary skin irritation) irritant
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 and 72 h
- Score:
- 0
- Reversibility:
- other: No erythema observed
- Remarks on result:
- other: On the both shaved intact and abraded skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 and 72 h
- Score:
- 0
- Reversibility:
- other: No edema observed
- Remarks on result:
- other: On the both shaved intact and abraded skin
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- - No signs of irritation were observed in any of treated animals (shaved intact and abraded skin) during the study period.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- expert judgment
- Conclusions:
- Application of undiluted N,N-Bis(2-Hydroxyethyl)-p-Phenylenediamine Sulfate to rabbit’s shaved intact and abraded skin did not produce skin irritation. The test substance was classified as non-irritant to rabbit skin.
- Executive summary:
The purpose of this in-vivo skin irritation test was to evaluate skin irritation potential of N,N-Bis(2-Hydroxyethyl)-p-Phenylenediamine Sulfate when applied to rabbit’s shaved intact and abraded skin.
6 rabbits (4 female and 2 male) were used in each treatment group (shaved intact and abraded skin). 500 mg of test substance was applied to the test site of each rabbit.
The treated skin site was observed for edema and erythema for 24 h and 72 h after treatment.
No signs of irritation were observed in any of the treated animals (shaved intact and abraded skin) during the study period.
Based on above, application of undiluted N,N-Bis(2-Hydroxyethyl)-p-Phenylenediamine Sulfate to rabbit’s shaved intact and abraded skin did not produce skin irritation. The test substance was classified as a non-irritant to rabbit skin.
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