Registration Dossier

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:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report Date:
1984

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
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

Test material

Reference
Name:
Unnamed
Type:
Constituent
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).

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):
not specified

Study design: in vivo (LLNA)

Concentration:
Not applicable
No. of animals per dose:
Not applicable
Details on study design:
Not applicable
Statistics:
Not applicable

Results and discussion

Positive control results:
Not applicable

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
10%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
10%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Remarks on result:
other: Not applicable
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: Not applicable

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.