Registration Dossier
Registration Dossier
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EC number: 607-286-1 | CAS number: 23911-26-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 04.09.2000-22.09.2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study meets the requirements of the OECD Principles of Good Laboratory Practice.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-{bis[2-(2,6-dioxomorpholin-4-yl)ethyl]amino}acetic acid
- Cas Number:
- 23911-26-4
- Molecular formula:
- C14H19N3O8
- IUPAC Name:
- 2-{bis[2-(2,6-dioxomorpholin-4-yl)ethyl]amino}acetic acid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Albino rabbit (SPF)
Test system
- Preparation of test site:
- shaved
- Vehicle:
- not specified
- Controls:
- not specified
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48 and 72 hours
- Number of animals:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: at 1, 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: at 1, 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: at 1, 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: at 1, 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: at 1, 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: at 1, 24, 48 and 72 h
- Score:
- 0
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated informationCriteria used for interpretation of results: EU
- Conclusions:
- DTPA-bis(anhydrid) tested as dry powder without being moistened shall not be classified as skin irritating.
- Executive summary:
Three rabbits were exposed to the test article at two skin sites on the back. After 4 hours of exposure the test article was removed and the skin examined 1, 24, 48 and 72 hours after termination of exposure.
No skin reactions were observed in any of the animals at any of the observations.
under the experimental conditions described in this report, the mean score for erythema was 0.0 and for oedema 0.0 .
DTPA-bis(anhydrid) tested as dry powder without being moistened shall not be classified as skin irritating.
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