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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:
2012
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
GLP compliance:
yes
Type of study:
mouse local lymph node assay (LLNA)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Specific details on test material used for the study:
LLNA: 355 (Cuminic Aldehyde)
Batch: 2080618
Supplier: Soda Aromatic Co., Ltd.
Clear colourless liquid
Storage: 2-8'C, refridgerated
Composition: Certification of analysis in appendix III of the report.

20 uCi of 3H-thymidine in sterile saline.


In vivo test system

Test animals

Species:
mouse
Strain:
CBA:J
Sex:
female
Details on test animals and environmental conditions:
Housed 5 per cage.
12 hour light and dark cycle.
Food and water ad litibum.
Acclimatised for a minimum of 6 days.

Study design: in vivo (LLNA)

No. of animals per dose:
5
Details on study design:
Groups of 5 CBA/J female mice were treated on the dorsal surface of both ears once per day for 3 days.
On day 6, the mice were injected with 20 uCi of 3H-thymidine in sterile saline.
Five hours later the mice were euthanised and the draining auricular lymh nodes removed.
The lymph nodes cells were pooled then prciptated with 5% trichloroacetic acid and the pellets counted in a beta-scintillation counter to determine incorporation of the 3H-thymidine.

Results and discussion

In vivo (LLNA)

Resultsopen allclose all
Key result
Parameter:
SI
Value:
2
Variability:
All animals per group no reactions.
Test group / Remarks:
No clinical observations
Parameter:
SI
Value:
1.1
Variability:
All animals per group no reactions.
Test group / Remarks:
No clinical observations
Parameter:
SI
Value:
1.3
Variability:
All animals per group no reactions.
Test group / Remarks:
No clinical observations
Parameter:
SI
Value:
1.5
Variability:
All animals per group no reactions.
Test group / Remarks:
No clinical observations
Parameter:
SI
Value:
2
Variability:
All animals per group no reactions.
Test group / Remarks:
No clinical observations

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the criteria of the OECD 429 test guidline, no dose levels gave an SI score of greater than 3. Therefore, cuminic aldehyde does not fufill the criteria as a skin sensitiser.