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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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).