Registration Dossier
Registration Dossier
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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.
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