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Description of key information

The skin sensitization potential of target chemical Nicotine sulphate (CAS No: 65-30-5) andits structurally similar read across substanceswas assessedin various experimental studies which were conducted on humans and guinea pigs.Based on the available key data and supporting studies,it can be concluded thatchemical Nicotine sulphate (CAS No: 65-30-5) is unable to cause skin sensitization and considered as sensitizing. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Non-Skin Sensitizer”.

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
Reference:
Composition 0
Qualifier:
according to
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
Test material information:
Composition 1
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
Reading:
1st reading
Hours after challenge:
48
Group:
test group
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 studieshas been investigated for the test chemicalNicotine sulphate (CAS No: 65-30-5) andits structurally similar read across substance to observe the potential for skin sensitization to a greater or lesser extent. The studies are based on in vivo experiments in human and guinea pigs for target chemicalNicotine sulphate (CAS No: 65-30-5) which have beensummarized as below;

 

The Patch tests were performed by a peer reviewed journal with aqueous solution of test chemical Nicotine sulphate (CAS No: 65-30-5) to determine the degree of allergenic reactions.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 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. Nicotine sulphate was considered to be an insensitive test agent, mostly due to its poor solubility. Hence, nicotine sulphate can be considered to be not sensitizing to skin.

 

The same patch test was conducted for another read across chemical by the same peer reviewed journal as mentioned in above study that supported the above mentioned result. The above result was supported by the patch test conducted by the same reviewed journal.The patches were applied to the backs of 14 volunteers (10male and 4 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 were further supported by the skin sensitization study of another read across chemical in guinea pigs to determine its sensitization potential.The preliminary irritation tests were performed in 8 guinea pigs to determine concentrations suitable for sensitization test [injection challenge concentration (ICC) and application challenge concentration(ACC)]. The concentration giving slight but perceptible irritation with no oedema was selected as the injection challenge concentration (ICC) and the highest concentration which caused no irritation was selected as the application challenge concentration (ACC). As a result of the preliminary studies, the concentration selected for skin sensitization test were 5% forICC and 20% for ACC.During the induction phase,the total dose was administered on one occasion as 4 intradermal injections, each 2.5 times the ICC (2.5X5%). Fourteen days later each animal was challenged intradermally in one flank and topically in the other with 0.1 ml aliquots of test substance at the respective ICC and ACC (5%and 20% respectively). Twenty-four hours later the reactions were observed.Reactions were examined under a constant and artificial day light.In the absence of sensitization reactions at first challenge the induction and challenge procedures were repeated, andapparent sensitization reactions confirmed 7 days later by a second and confirmatory challenge with controls included. At 24 hours after the first challenge(A1)and at the second(B1)and confirmatory challenge(B2)with 5% and 20% of test chemical none of the rabbits showed positive results. Thus, it can be concluded that thetest chemicalwas considered to be not sensitizing onguinea pigs.

 

Based on the available key data and supporting studies,it can be concluded thatchemical Nicotine sulphate (CAS No: 65-30-5) is unable to cause skin sensitization and considered as Non-skin sensitizing. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Non skin sensitizer”.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The skin sensitization potential of test substance Nicotine sulphate (CAS No: 65-30-5) andits structurally similar read across substanceswere observed in various studies. From the results obtained from these studies it is concluded that the chemical Nicotine sulphate (CAS No: 65-30-5) is unlikely to cause skin sensitization and hence can be classified as “Non-Skin Sensitizer”.