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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:
weight of evidence
Study period:
2008
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature

Data source

Reference
Reference Type:
publication
Title:
Dermal Sensitization quantitative risk assessment (QRA) for fragrance ingredients
Author:
A.M. Api et al
Year:
2007
Bibliographic source:
Regulatory Toxicology and Pharmacology 52
Report date:
2007

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
other: Local Lymph Node Assay; details on guidelines not specified.
Deviations:
not specified
Principles of method if other than guideline:
Local Lymph Node Assay; no further details on the method were reported.
GLP compliance:
not specified
Type of study:
mouse local lymph node assay (LLNA)

Test material

Constituent 1
Chemical structure
Reference substance name:
trans-hex-2-enal
EC Number:
229-778-1
EC Name:
trans-hex-2-enal
Cas Number:
6728-26-3
Molecular formula:
C6H10O
IUPAC Name:
trans-hex-2-enal
Test material form:
liquid
Specific details on test material used for the study:
No details reported.

In vivo test system

Test animals

Species:
mouse
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
No details reported.

Study design: in vivo (LLNA)

Vehicle:
not specified
Concentration:
No details reported.
No. of animals per dose:
No details reported.
Details on study design:
No details reported.
Positive control substance(s):
not specified
Statistics:
No details reported.

Results and discussion

In vivo (LLNA)

Resultsopen allclose all
Key result
Parameter:
EC3
Value:
4.048
Remarks on result:
other: LLNA weighted mean EC3 value ( 1012 μg/cm2); converted to 4.048 % concentration based on the assumption that the application of 25 μl of a 1 % solution results in a dose per unit area of 250 μg/cm2.
Remarks:
Considered 'moderate'
Parameter:
SI
Variability:
No details reported
Test group / Remarks:
No details reported
Remarks on result:
other: No details reported
Cellular proliferation data / Observations:
No details reported.

Applicant's summary and conclusion

Interpretation of results:
Category 1A (indication of significant skin sensitising potential) based on GHS criteria
Conclusions:
The LLNA EC3 value was reported as a weighted mean of two studies with a value of 1012 μg/cm2. The authors reported this value to be a 'moderate' skin sensitiser. Assuming that the application of 25 μl of a 1 % solution results in a dose per unit area of 250 μg/cm2 the EC3 value is converted to a percentage concentration of 4.048. Therefore, the test item is classified as a Category 1A for skin sensitisation (H317) according to CLP criteria (EC Regulation 1272/2008).
Executive summary:

The LLNA EC3 value was reported as a weighted mean of two studies with a value of 1012 μg/cm2. The authors reported this value to be a 'moderate' skin sensitiser. Assuming that the application of 25 μl of a 1 % solution results in a dose per unit area of 250 μg/cm2 the EC3 value is converted to a percentage concentration of 4.048. Therefore, the test item is classified as a Category 1A for skin sensitisation (H317) according to CLP criteria (EC Regulation 1272/2008).