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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
not specified
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data

Data source

Reference
Reference Type:
review article or handbook
Title:
Unnamed
Year:
2005

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
not specified
GLP compliance:
not specified
Type of study:
mouse local lymph node assay (LLNA)

Test material

Constituent 1
Reference substance name:
Ethyl benzoylacetate
EC Number:
202-295-3
EC Name:
Ethyl benzoylacetate
Cas Number:
94-02-0
Molecular formula:
C11H12O3
Test material form:
not specified
Specific details on test material used for the study:
Not specified

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
female
Details on test animals and environmental conditions:
- Age at study initiation: 7-12 weeks

Study design: in vivo (LLNA)

Vehicle:
other: acetone
Concentration:
10, 20 or 40 %
No. of animals per dose:
according to OECD 429 test guideline
Details on study design:
Animals were exposed topically on the dorsum of both ears to 25 µL of test material or to an equal volume of the relevant vehicle alone. Treatment was performed daily for 3 consecutive days. Five days after the initiation of exposure, all mice were injected via the tail vein with 250 µL of phosphate-buffered saline containing 20 µCi of tritiated thymidine. The mice were sacrificed 5 hours later, and the draining auricular lymph nodes were excised and pooled for each experimental group or each individual animal. The incorporation of tritiated thymidine measured by beta scintillation counting was reported in disintegrations per minute. An SI was calculated for each chemical-treated group as the ratio of the disintegrations per minute in the treated group (or mean disintegrations per minute when individual animals were assessed) to the disintegrations per minute or mean disintegrations per minute of the concurrent vehicle control group. A substance was classified as a skin sensitizer if, at one or more test concentrations, it induced a threefold or greater increase in local lymph node proliferative activity when compared with concurrent vehicle-treated controls (SI, >= 3).
Positive control substance(s):
not specified

Results and discussion

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Value:
0.9
Test group / Remarks:
10%
Parameter:
SI
Value:
0.9
Test group / Remarks:
20%
Parameter:
SI
Value:
1.2
Test group / Remarks:
40%
Cellular proliferation data / Observations:
CELLULAR PROLIFERATION DATA
not specified

EC3 CALCULATION
not calculated. All results < 3

CLINICAL OBSERVATIONS:
not specified

BODY WEIGHTS
not specified

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Not classified by CLP criteria
Conclusions:
In a guideline OECD 429 study (in vivo LLNA), ethyl benzoylacetate was not sensitizing.

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