Registration Dossier
Registration Dossier
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EC number: 204-685-9 | CAS number: 124-17-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- Please see cross reference attachments shown below
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable study with basic documentation which meets basic scientific principles and contains sufficient detail to be able to judge the results reliable as a contribution to the understanding of the toxicity of this substance.
- Principles of method if other than guideline:
- Method according to (unspecified) French regulations of 1971 which are in turn derived from the method of Draize (1959). The Draize method is the origin of the OECD test method.
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- other: New Zealand (unspecified)
- Type of coverage:
- not specified
- Preparation of test site:
- other: both intact and abraded skin areas exposed
- Vehicle:
- not specified
- Number of animals:
- 6
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 0.17
- Max. score:
- 8
- Reversibility:
- fully reversible within: 72 hours
- Irritant / corrosive response data:
- Four out of the 6 rabbits showed very slight erythema (grade 1) at 24 hours. There was full recovery by 72 hours.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Executive summary:
In an in vivo skin irritation study in which basic details are available, 2 -butoxyethyl acetate produced only very slight irritation in some of the exposed rabbits which was fully reversed within 72 hours. The response did not meet the threshold for classification as a skin irritant. This result is considered representative of the skin irritation potential of 2 -(2 -butoxyethoxy)ethyl acetate.
Synopsis
Not irritating.
A primary skin irritation index of 5 or more is considered a positive response.
- Reason / purpose for cross-reference:
- read-across: supporting information
Data source
Materials and methods
Test material
- Reference substance name:
- 2-(2-butoxyethoxy)ethyl acetate
- EC Number:
- 204-685-9
- EC Name:
- 2-(2-butoxyethoxy)ethyl acetate
- Cas Number:
- 124-17-4
- Molecular formula:
- C10H20O4
- IUPAC Name:
- 2-(2-butoxyethoxy)ethyl acetate
- Details on test material:
- - Name of test material (as cited in study report): Butyldiglycolacetat, 2-(2-butoxyethoxy)ethyl acetate
- Physical state: colourless liquid
- Analytical purity: 98,4 mass%
- Lot/batch No.: Beh. 6
Constituent 1
Results and discussion
In vivo
Results
- Remarks on result:
- probability of weak irritation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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