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Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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 according to GLP.
Qualifier:
equivalent or similar to guideline
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
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
Route:
intradermal
Vehicle:
corn oil
Concentration / amount:
tested as 10% solution in maize germ oil for injection. 100% for topical application
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)
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
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 chemical
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.

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.

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:
Justification for selection of skin sensitisation endpoint:
Only reliable study available

Justification for classification or non-classification