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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vitro
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Data from study report

Data source

Reference
Reference Type:
publication
Title:
Comparison of the DPRA with a Three-Test Battery for In Vitro Evaluation of Skin Sensitization
Author:
W Stokes, T Burns, J Strickland, L Rinckel, D Allen NICEATM/NTP/HHS, RTP, NC, USA; ILS, Inc., RTP, NC, USA
Year:
2012
Bibliographic source:
NICEATM–ICCVAM SOT 2012 Poster

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: as mentioned below
Principles of method if other than guideline:
The Hydratropic aldehyde (93-53-8) found to be sensitizing when used in different In vitro test (Direct protein reactivity assay, (DPRA) Human cell line activation test (h-CLAT),KeratinoSens).
GLP compliance:
no
Type of study:
other: Direct protein reactivity assay (DPRA); Human cell line activation test (h-CLAT); KeratinoSens; Local lymph node assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: Liquid
Details on test material:
- Name of test material: Hydratropaldehyde
- Molecular formula: C9H10O
- Molecular weight: 134.17 g/mol
- Smiles notation: CC(C=O)C1=CC=CC=C1
- Substance type: Liquid
- Physical state: Organic
- Impurities (identity and concentrations): No data

In vivo test system

Test animals

Species:
human
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
No data available

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
other: No data available
Vehicle:
other: AOO = Acetone: olive oil (4:1 by volume)
Concentration / amount:
No data available
Challengeopen allclose all
Route:
other: No data available
Vehicle:
other: AOO = Acetone: olive oil (4:1 by volume)
Concentration / amount:
No data available
No. of animals per dose:
No data available
Details on study design:
No data available
Challenge controls:
No data available
Positive control substance(s):
not specified

Results and discussion

Positive control results:
No data available

In vitro / in chemico

Results
Parameter:
other: Migrated information from in vitro study
Remarks on result:
other: Reading: 1st reading. Group: test group. Clinical observations: sensitizing.

Any other information on results incl. tables

Not specified

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The Hydratropic aldehyde (93-53-8) found to be sensitizing when used in different In vitro test (Direct protein reactivity assay, (DPRA) Human cell line activation test (h-CLAT),KeratinoSens).
Executive summary:
By using different in vitro assays: DPRA, the human cell line activation test (h-CLAT), and KeratinoSens use for skin sensitization testing. The murine local lymph node assay was used as the reference test.

From the above table it was found that theHydratropic aldehyde (93-53-8) found to be sensitizing when used in different In vitro test (Direct protein reactivity assay, (DPRA) Human cell line activation test (h-CLAT),KeratinoSens).

According to the CLP regulations the chemical was classified in category skin sensitization 1.