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Description of key information

Patch tests were performed with aqueous solution of test chemical to determine the degree of allergenic reactions. Patch tests were carried out with European Standard series except for primin(TRUE TEST) with 5% aqueous test chemical were tested. The patches were applied to the backs of 14 volunteers (10male and 5 female) and were read at 2 and 3 days according to the recommendations of the ICDRG. Positive patch test reactions were further assessed as irritant or allergic. Positive reactions were observed in only 1 volunteer. The test chemical was considered to be an insensitive test agent, mostly due to its poor solubility. Hence, the test chemical can be considered to be not sensitizing to skin.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
data is from peer reviewed journals
Qualifier:
according to guideline
Guideline:
other: as mentioned below
Principles of method if other than guideline:
Patch tests were performed with aqueous solution of test chemical to determine the degree of allergenic reactions
GLP compliance:
not specified
Type of study:
patch test
Justification for non-LLNA method:
not specified
Species:
other: humans
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Department of Dermatology, University of Basel, Switzerland
- Age at study initiation: mean age – 38.6 years (range 23 – 65 years)
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
5% aqueous solution
Day(s)/duration:
no data available
Adequacy of induction:
not specified
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
5% aqueous solution
Day(s)/duration:
no data available
Adequacy of challenge:
not specified
No. of animals per dose:
10 male and 4 female
Details on study design:
Other: Patch tests were carried out with European Standard series except for primin(TRUE TEST) with aqueous nicotine sulphate 5% were tested. The patches were applied to the backs of subjects and were read at 2 and 3 days according to the recommendations of the ICDRG.
Positive patch test reactions were further assessed as irritant or allergic.
Challenge controls:
no data available
Positive control substance(s):
not specified
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
5% aqueous solution
No. with + reactions:
1
Total no. in group:
14
Clinical observations:
Positive reactions were observed in only 1 volunteer.The test chemical was considered to be an insensitive test agent, mostly due to its poor solubility
Remarks on result:
no indication of skin sensitisation
Interpretation of results:
other: not sensitizing
Conclusions:
Positive reactions were observed in only 1 volunteer.The test chemical was considered to be an insensitive test agent, mostly due to its poor solubility.Hence,the test chemical can be considered to be not sensitizing to skin.
Executive summary:

Patch tests were performed with aqueous solution of test chemical to determine the degree of allergenic reactions. Patch tests were carried out with European Standard series except for primin(TRUE TEST) with 5% aqueous test chemical were tested. The patches were applied to the backs of 14 volunteers (10male and 5 female) and were read at 2 and 3 days according to the recommendations of the ICDRG. Positive patch test reactions were further assessed as irritant or allergic. Positive reactions were observed in only 1 volunteer.The test chemical was considered to be an insensitive test agent, mostly due to its poor solubility. Hence, the test chemical can be considered to be not sensitizing to skin.

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

Various studies have been reviewed to evaluate the degree of contact sensitization caused by the test chemical in living organisms. These include in vivo experimental studies performed on humans as well as mice. The results are as follows:

Patch tests were performed with aqueous solution of test chemical to determine the degree of allergenic reactions. Patch tests were carried out with European Standard series except for primin(TRUE TEST) with 5% aqueous test chemical were tested. The patches were applied to the backs of 14 volunteers (10male and 5 female) and were read at 2 and 3 days according to the recommendations of the ICDRG. Positive patch test reactions were further assessed as irritant or allergic. Positive reactions were observed in only 1 volunteer.The test chemical was considered to be an insensitive test agent, mostly due to its poor solubility. Hence, the test chemical can be considered to be not sensitizing to skin.

This is supported by another patch test conducted to determine the degree of contact sensitization caused by the chemical. The patches were applied to the backs of 14 volunteers (10male and 5 female) at concentration of 1% of aqueous solution of test chemical and were read at 2 and 3 days according to the recommendations of the ICDRG. Positive patch test reactions were further assessed as irritant or allergic. Since only one volunteer had positive reaction out of 14 patients, the test material was considered as not sensitizing to the skin at tested concentration

The above results are supported by a mouse local lymphnode assay performed to evaluate the dermal sensitization potential of the test chemical in mice. The study was conducted as per OECD 429 and EPA OPPTS 870.2600. Method Guidelines. 20 female mice were used for the study. Daily applications of 25μl of 0, 2.5, 5 and 10% test chemical in DMSO to the dorsal surface of each ear were done for three consecutive days (days 1, 2, 3). Three days following the last application of the test material all mice were injected with 20 μCi 3H-methyl thymidine. The proliferation response of lymph node cells was expressed as the dpm in the lymph node and as the ratio of 3H-methyl thymidine incorporation into lymph node cells of test nodes relative to that recorded for the control nodes (Stimulation Index) was calculated. A stimulation index of 1.07, 0.94 and 1.23 were recorded for the three concentrations viz. 2.5, 5 and 10%, respectively of the test material. Since the Stimulation Index for all the concentrations were below 3, hence no EC3 could be calculated. Based on these scores, the test chemical can be considered to be not sensitizing to skin.

 

Based on the available results, the test chemical can be considered to be not sensitizing to skin. Hence, the test chemical can be classified under the category "Not Classified" as per CLP Regulation.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the available results, the test chemical can be considered to be not sensitizing to skin. Hence, the test chemical can be classified under the category "Not Classified" as per CLP Regulation.