Registration Dossier

Administrative data

Description of key information

Skin sensitisation

Based on the result obtained from the studies available for the structurally similar read across chemicals, it can be concluded that the test chemical cannot cause skin sensitization and thus cannot be considered as skin sensitizing.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Remarks:
experimental data from various test chemicals
Justification for type of information:
Data is summarized based on the available information from various test chemicals.
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Qualifier:
according to guideline
Guideline:
other: as mentioned below
Principles of method if other than guideline:
WoE report is based on 2 skin sensitization studies as- WoE-2 and WoE-3.
Skin sensitization of test chemical was determined by mouse local lymph node assay (LLNA).
GLP compliance:
not specified
Type of study:
mouse local lymph node assay (LLNA)
Species:
mouse
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
not specified
Vehicle:
other: 2. not specified 3. propylene glycol
Concentration:
2. 5 %, 10 %, and 25 % of the test substance (w/w)
3. concentrations 2.5%, 5%, 10%,25% and 50%
No. of animals per dose:
2. No data available
3. 20 (5 groups of 4 animals)
Details on study design:
2. No data available
3. TREATMENT PREPARATION AND ADMINISTRATION: Five groups of 4 animals were exposed to the test substance on 3 consecutive days (concentrations 2.5%, 5%, 10%, 25% and 50%) in parallel with a negative control group receiving the vehicle propylene glycol and a positive control group receiving the moderate sensitiser alpha-hexylcinnamaldehyde.
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)
not specified
Statistics:
2. No data available
3. Not specified
Positive control results:
2. No data available
3. A significant lymphoproliferation was noted in the positive control given alpha-hexylcinnamaldehyde. The study was therefore considered valid
Parameter:
SI
Remarks:
2
Value:
1.3
Test group / Remarks:
test group
Remarks on result:
other: at concentration of 5%
Parameter:
SI
Remarks:
2
Value:
1.5
Test group / Remarks:
test group
Remarks on result:
other: at concentration of 10%
Parameter:
SI
Remarks:
2
Value:
1.2
Test group / Remarks:
test group
Remarks on result:
other: at concentration of 25%
Parameter:
SI
Remarks:
3
Value:
< 3
Test group / Remarks:
4 animals
Remarks on result:
other: The Stimulation Index was below 3 (range: 1.01 to 1.79)
Cellular proliferation data / Observations:
2. the chemical did not have sensitizing effects up to concentrations of 25%
3. The Stimulation Index was below 3 (range: 1.01 to 1.79) and no dose response reaction was observed. No systemic clinical signs and mortality, neither changes in body weight, nor local irritation was observed for all tested concentrations.
Interpretation of results:
other: Not Sensitizing
Conclusions:
Based on the result obtained from the studies available for the structurally similar read across chemicals, it can be concluded that the test chemical cannot cause skin sensitization and thus cannot be considered as skin sensitizing.
Executive summary:

The skin sensitization potential was assessed based on the available results from the various test chemicals.These studies have been summarized as below -

 

A mouse local lymph node assay (LLNA) was conducted for test chemical to determine its sensitizing effects. In this study, the application of 5%, 10% and 25% test chemical resulted in stimulation indices of 1.3, 1.5 and 1.2, respectively. Thus, a tripling of the lymphocyte stimulation was not reached with any of the test concentrations. Since, the chemical did not have sensitizing effects up to concentrations of 25%, it was considered as not sensitizing.

 

The above study was supported with another local lymph node assay performed to detect the delayed contact hypersensitivity in mice according to the OECD guideline 429 and to the EU Method B.42 for the given test chemical. Five groups of 4 animals were exposed to the test substance on 3 consecutive days (concentrations 2.5%, 5%, 10%, 25% and 50%) in parallel with a negative control group receiving the vehicle propylene glycol and a positive control group receiving the moderate sensitiser alpha-hexylcinnamaldehyde. After 2 days of resting, the animals were sacrificed in order to perform the proliferation assay. Changes in body weight, ear thickness were noted and the animals were checked on a regular base for clinical signs, mortality and local irritation. A significant lymphoproliferation was noted in the positive control given alpha-hexylcinnamaldehyde. The study was therefore considered valid. No noteworthy lymphoproliferation was noted with the test substance at any tested concentration. The Stimulation Index was below 3 (range: 1.01 to 1.79) and no dose response reaction was observed. No systemic clinical signs and mortality, neither changes in body weight, nor local irritation was observed for all tested concentrations. Since the test chemical failed to induce any contact sensitization effect in treated animals, it was considered as not sensitizing.

 

Based on the result obtained from the studies available for the structurally similar read across chemicals, it can be considered that the test chemical cannot cause skin sensitization and thus cannot be considered as skin sensitizing.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Skin sensitization

The skin sensitization potential was assessed based on the available results from the various test chemicals.These studies have been summarized as below -

 

A mouse local lymph node assay (LLNA) was conducted for test chemical to determine its sensitizing effects. In this study, the application of 5%, 10% and 25% test chemical resulted in stimulation indices of 1.3, 1.5 and 1.2, respectively. Thus, a tripling of the lymphocyte stimulation was not reached with any of the test concentrations. Since, the chemical did not have sensitizing effects up to concentrations of 25%, it was considered as not sensitizing.

 

The above study was supported with another local lymph node assay performed to detect the delayed contact hypersensitivity in mice according to the OECD guideline 429 and to the EU Method B.42 for the given test chemical. Five groups of 4 animals were exposed to the test substance on 3 consecutive days (concentrations 2.5%, 5%, 10%, 25% and 50%) in parallel with a negative control group receiving the vehicle propylene glycol and a positive control group receiving the moderate sensitiser alpha-hexylcinnamaldehyde. After 2 days of resting, the animals were sacrificed in order to perform the proliferation assay. Changes in body weight, ear thickness were noted and the animals were checked on a regular base for clinical signs, mortality and local irritation. A significant lymphoproliferation was noted in the positive control given alpha-hexylcinnamaldehyde. The study was therefore considered valid. No noteworthy lymphoproliferation was noted with the test substance at any tested concentration. The Stimulation Index was below 3 (range: 1.01 to 1.79) and no dose response reaction was observed. No systemic clinical signs and mortality, neither changes in body weight, nor local irritation was observed for all tested concentrations. Since the test chemical failed to induce any contact sensitization effect in treated animals, it was considered as not sensitizing.

 

Based on the result obtained from the studies available for the structurally similar read across chemicals, it can be considered that the test chemical cannot cause skin sensitization and thus cannot be considered as skin sensitizing.

 

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the result obtained from the studies available for the structurally similar read across chemicals, it can be concluded that the test chemical cannot cause skin sensitization and thus cannot be considered as skin sensitizing.