Registration Dossier

Administrative data

Description of key information

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.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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
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
Species:
human
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
No data available
Route:
other: No data available
Vehicle:
other: AOO = Acetone: olive oil (4:1 by volume)
Concentration / amount:
No data available
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
Positive control results:
No data available
Parameter:
other: Migrated information from in vitro study
Remarks on result:
other: Reading: 1st reading. Group: test group. Clinical observations: sensitizing.

Not specified

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.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

The skin sensitization by (W Stokes et al., 2012) of Hydratropaldehyde was assessed in human.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 value it was found that 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). According to the CLP regulations the chemical was classified in category skin sensitization 1.

In a supporting study, the skin sensitization by (National Toxicology Program, 2009)of Hydratropaldehyde was assessed in mouse. Reduced LLNA assay was performed on mouse with different concentrations as 0.5, 1, 2.5, 5, 10 %.From the LLNA study the concentrations used to study were used. Compared to the traditional LLNA, the rLLNA will reduce the number of animals used to assess skin sensitization. In addition to a concurrent vehicle-control group and a positive-control group, the traditional LLNA requires testing four to five mice with each of at least three test-substance dose levels. Because the rLLNA tests only the highest dose level of the test substance being evaluated, in addition to the concurrent control groups, the number of animals tested would be decreased by at least 40% for each test. The vehicle used was acetone: olive oil (4:1). So from the above study it was found that Hydratropic aldehyde (93-53-8) was found to be sensitizing to ear of mouse. According to the CLP regulations the chemical was classified in category skin sensitization 1.

In a supporting study, the skin sensitization by (D.L.J. Opdyke ,1975)of Hydratropaldehyde was assessed in human .Sensitization test was performed on 25 volunteers by maximization test. The chemical tested at a concentration was 2% in petrolatum and found to be non-sensitizing. Therefore, the hydratropic aldehyde (93-53-8) to 25 volunteer was found to be non-sensitizing.

On the basis of available information from majority of target studies , the test substance can be considered as sensitising to the skin, in accordance with the CLP criteria.

Migrated from Short description of key information:
The skin sensitization by (W Stokes et al., 2012) of Hydratropaldehyde was assessed in human.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 value it was found that 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).

Justification for selection of skin sensitisation endpoint:
The skin sensitization by (W Stokes et al., 2012) of Hydratropaldehyde was assessed in human.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 value it was found that 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).The test substanceHydratropaldehyde can be considered assensitising to the skin, can be classified in sin sensitization category 1, in accordance with the CLP criteria. 

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The test substanceHydratropaldehyde can be considered assensitising to the skin, can be classified in sin sensitization category 1, in accordance with the CLP criteria.