Registration Dossier
Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 212-112-9 | CAS number: 763-69-9
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Not applicable
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non-GLP study equivalent to OECD guideline 406
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Principles of method if other than guideline:
- Conducted according to standard operating procedures of the Eastman Kodak laboratory.
- GLP compliance:
- not specified
- Type of study:
- Freund's complete adjuvant test
- Justification for non-LLNA method:
- Study was conducted prior to the implementation of the LLNA requirement.
Test material
- Reference substance name:
- Ethyl 3-ethoxypropionate
- EC Number:
- 212-112-9
- EC Name:
- Ethyl 3-ethoxypropionate
- Cas Number:
- 763-69-9
- Molecular formula:
- C7H14O3
- IUPAC Name:
- ethyl 3-ethoxypropanoate
- Details on test material:
- - Name of test material (as cited in study report): Ethyl 3-ethoxypropionate (EEP)
- Physical state: liquid
- Analytical purity: 99.8%
- Impurities (identity and concentrations): acetic acid, ethyl propionate and ethyl acrylate as the trace impurities
- Purity test date: no data
- Lot/batch No.: A total of three batches were received for inhalation tests. One batch, identified as SR1D:X-17695-233, was used exclusively for technical development and the LC 50 study (HS&HFL No. 83-0162).
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- female
- Details on test animals and environmental conditions:
- No data
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- no data
- Concentration / amount:
- induction: 1% in vehicle (A+D+G.P. Fat)
challenge: 10% in vehicle (A+D+G.P. Fat)
Challengeopen allclose all
- Route:
- epicutaneous, open
- Vehicle:
- no data
- Concentration / amount:
- induction: 1% in vehicle (A+D+G.P. Fat)
challenge: 10% in vehicle (A+D+G.P. Fat)
- No. of animals per dose:
- pre-test for irritation: 5
main study: 10 - Details on study design:
- A. INDUCTION EXPOSURE
- No. of exposures: 1 injection
- Test groups: 1 % CPD in Freund's (10 animals)
- Control group: Freund's only (10 animals)
- Site: footpad
B. CHALLENGE EXPOSURE
- No. of exposures: 1 drop-on application
- Day(s) of challenge: 7 days
- Test groups: 10 % CPD in Freund's (10 animals)
- Control group: Freund's only (10 animals)
- Site: no data
- Evaluation (hr after challenge): 24 and 48 hours - Challenge controls:
- 10 animals (Freund's only)
- Positive control substance(s):
- no
Results and discussion
- Positive control results:
- No positive control included in the report.
In vivo (non-LLNA)
Resultsopen allclose all
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Remarks:
- No positive control results specified.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- Control
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- Control
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- No positive response was seen in any of the animals tested in the first and second reading in a standardized test for sensitization potential.
- Executive summary:
No positive response was seen in any of the animals tested in the first and second reading in a standardized test for sensitization potential.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
