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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study but not to GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
, Sodium lauryl sulphate not used prior to topical application. 
GLP compliance:
no
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
An LLNA study does not need to be conducted because adequate reliable data is available from this alternative study indicating the potential for skin sensitisation.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Test substance: other TS
- Ethyl acetate
- Analytical Purity: 99.9%.
- Impurities: acetaldehyde, ethanol
- Continuous production sample from tank C4, 27.Jan.88

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: F. Winkelmann, Borchen. 
- Age at study initiation: Not specified
- Weight at study initiation: Test group average  weight 328.5g, control 308.2g.
- Acclimation period: 4-8 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/-1
- Humidity (%): 60% +/-5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
corn oil
Concentration / amount:
tested as 10% solution in maize germ oil for injection. 100% for topical application
Challenge
Concentration / amount:
tested as 10% solution in maize germ oil for injection. 100% for topical application
No. of animals per dose:
20, 10 for control group.
Details on study design:
A. INDUCTION EXPOSURE
- No. of exposures: 1
- Test groups: 1
- Control group: 1
- Site: Shoulder, prepared by clipping 6 hours before start of test.
- Frequency of applications: single application
- Concentrations: Injection 1: 0.1ml test substance 10% in corn oil. Injection 2: 0.1ml test substance 10% in a 1:1 mixture of FCA and corn oil. Injection 3: 0.1ml 1:1 mixture of FCA/water. Injections given in pairs either side of shoulder (6 injections in total). The control group received the same injections but without the test substance present. Sodium lauryl sulphate not used prior to topical application. After 1 week, 2x4cm filter paper loaded with test substance held in contact under occlusive dressing (Leukoflex) for 48 hours. Skin shaved beforehand. Control group received corn oil.


B. CHALLENGE EXPOSURE
- No. of exposures:
- Day(s) of challenge: After 2 weeks from induction exposure.
- Exposure period: 24 hours on impregnated filter paper occluded with Leukoflex tape.
- Test groups: 1
- Control group: 1
- Site: Left flank (shaved 2-3 hours before exposure)
- Concentrations: 100%
- Evaluation (hr after challenge): 24 and 48 hours after exposure (removal of dressing)

Study design: in vivo (LLNA)

No. of animals per dose:
10

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0.

Any other information on results incl. tables

General reactions did not occur during the test, the treatment had no detrimental effect on the development of body weight.  (All individual animal weights reported at each significant time point.) After intracutaneous application: clear reddening, swelling and necroses at the injection sites treated with FCA and deionised water (1:1) (Test and control animals).  Clear reddening and swelling at the injection sites treated with the 10% product in maize germ oil (Test).  The control with just maize germ oil only showed slight reddening and swelling at the injection sites.  Clear reddening and swelling and slight necroses at the injection sites treated with 10% product n a mixture of FCA and maize germ oil, 1:1 (Test) and those treated with FCA and maize germ oil, 1:1 (control).  2. After patch test with a contact duration of 48 h.  Inflammation at all the injection sites treated with FCA.  24h after removal of the patch, crust formation at the injection sites. 

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Classification: not sensitizing
Executive summary:

In a guideline (OECD 406) study using the guinea pig maximization test, ethyl acetate showed no evidence of any sensitising properties.