Registration Dossier

Administrative data

Description of key information

Skin sensitization effects were estimated by four different models i.e, Battery, Leadscope, SciQSAR and CASE Ultra used within Danish QSAR database for the test chemical. Based on estimation, no skin sensitization reactions were observed in guinea pigs and humans. Therefore, the test chemical was considered to be not sensitizing.  

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
calculation (if not (Q)SAR)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
accepted calculation method
Justification for type of information:
Data is from authoritative database
Qualifier:
according to
Guideline:
other: estimated data
Principles of method if other than guideline:
To estimate the Allergic Contact Dermatitis caused by the test chemical in Guinea Pigs and Humans
GLP compliance:
not specified
Type of study:
other: Allergic Contact Dermatitis in Guinea Pig and Human
Specific details on test material used for the study:
- Name of test material (as cited in study report): tridecan-1-ol
- Molecular formula : C13H28O
- Molecular weight : 200.37 g/mol
- Smiles notation (if other than submission substance): C(CCCCCCO)CCCCCC
- InChl (if other than submission substance): 1S/C13H28O/c1-2-3-4-5-6-7-8-9-10-11-12-13-14/h14H,2-13H2,1H3
- Substance type: Organic
- Physical state: Solid
Species:
other: Guinea Pig and Human
Strain:
not specified
Sex:
not specified
Route:
other: No data available.
Vehicle:
not specified
Adequacy of induction:
not specified
No.:
#1
Route:
other: No data available.
Vehicle:
not specified
Adequacy of challenge:
not specified
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
Statistics:
No data available.
Reading:
1st reading
Group:
test group
No. with + reactions:
0
Clinical observations:
No skin sensitization effect were observed.
Remarks on result:
no indication of skin sensitisation

Table showing allergic dermatitis estimation by three different models i.e, Leadscope, battery and SciQSAR & CASE Ultra,the average results was given by the fourth model i.e, Battery model.

 

Exp

Battery

CASE Ultra

Leadscope

SciQSAR

Allergic Contact Dermatitis in Guinea Pig and Human

NA

NEG_IN

NEG_IN

NEG_IN

NEG_IN

                                                                    Where,

IN = inside applicability domain, NEG = Negative; INC = Inconclusive; POS = Positive, OUT = outside applicability domain

 

Interpretation of results:
other: Not sensitizing
Conclusions:
Based on the QSAR prediction done using the Danish (Q)SAR Database, the skin sensitization for the test chemical was estimated to be not sensitizing on guinea pig and humans. Thus it can be concluded that the test chemical has no skin sensitization effects.
Hence, the test chemical can be considered to be not sensitizing to skin.
Executive summary:

Skin sensitization effects were estimated by four different models i.e, Battery, Leadscope, SciQSAR and CASE Ultra used within Danish QSAR database for the test chemical. Based on estimation, no skin sensitization reactions were observed in guinea pigs and humans. Therefore, the test chemical was considered to be not sensitizing.  

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

The dermal sensitization potential of the test chemical was assessed based on the available results from the various test chemicals.

Skin sensitization effects were estimated by four different models i.e, Battery, Leadscope, SciQSAR and CASE Ultra used within Danish QSAR database for the test chemical. Based on estimation, no skin sensitization reactions were observed in guinea pigs and humans. Therefore, the test chemical was considered to be not sensitizing.  

This estimated result is supported by An Open Epicutaneous Test (OET) performed on guinea pigs to assess the skin sensitization potential of test chemical. The pretest was performed to determine the primary irritating threshold concentration of test substances at various concentrations (e.g, 100,30,10 and 3%). In this test, a single application of 0.025 ml of each test concentration was simultaneously performed on one of the areas measuring 2 cm2 of the flank skin previously clipped and marked with a circular stamp. Reactions are read 24 h after the application of the test material. On the basis of pretest, the concentration selected for sensitization test was 4 %.

On day 1 during induction, 0.1 ml of the test chemical was applied at concentrations of 4 % in vehicle to an area measuring 8 cm2 on the clipped flank skin of the guinea pigs. The applications are repeated daily for 3 weeks or done 5 times weekly during 4 weeks, usually on the same skin sites. The application sites were left uncovered and the reactions, if continuous daily applications were performed, can be read 24 h after each application, or at the end of each week.

To determine whether or not contact sensitization was induced, all groups of guinea pigs previously treated for 21 days, as well as 10 untreated, or only pretreated with the vehicle, controls are tested on days 21 and 35 on the contralateral flank with the test material. This test was performed by applying with a pipette 0.025 ml of chemical to skin areas measuring 2 cm2. The reactions were read after 24, 48 and/or 72h.

It was observed that none of the guinea pigs induced contact sensitization at challenge concentration of 4%.Thus the test chemical was considered to be not sensitizing on skin of guinea pigs at concentration of 4% in an Open Epicutaneous Test (OET).

These results are supported by a Draize test conducted in Himalayan white-spotted guinea pigs (male and female) to determine the skin sensitization potential of the test chemical. 

In this test, the 6-8 guinea pigs received a dose of 0.05 ml of a 0.1 % solution of the chemical tested in isotonic saline intradermally on day 0 and further doses of 0.1 ml each were injected on 9 alternate days (total dose = 0.95 mg). The treated animals and untreated controls were challenged intradermally with 0.05 ml of a 0.1 per cent solution on days 35 and 49.

The evaluation criterion was the mean diameter of the popular reactions.

None of the treated animals showed positive skin reactions. Hence, the test chemical was considered to be not sensitizing to the skin of Himalayan white-spotted guinea pigs.

These results are further supported by a sensitization study performed according to Modified Draize method in 10 Inbred Hartley strain albino guinea pigs to determine the sensitization potential of the test chemical. The preliminary irritation tests were done in guinea pigs to determine concentrations suitable for sensitization testing [injection challenge concentration(ICC) and application challenge concentration(ACC) ]

In the induction phase, the total dose was administered on one occasion as 4 intradermal injections, each 2.5 times the ICC (2.5X 0.1). 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 (0.1 and 10 respectively). Twenty-four hours later the reactions were observed. In the absence of sensitization reactions at first challenge the induction and challenge procedures were repeated, and apparent sensitization reactions confirmed 7 days later by a second challenge with controls included.

Based upon the second challenge, it can be concluded that the test chemical was considered to be non-sensitizing to the skin of albino Hartley guinea pigs at 0.1% ICC and 10% ACC concentrations.

The above results are further supported by a human maximization study carried out on 25 human volunteers to determine skin sensitization potential caused by the test chemical.

3% test chemical in petrolatum was applied to the skin of 25 human volunteers and later observed for signs of contact allergy. None of the volunteers showed any signs of contact sensitization. Hence the test chemical was considered to be not sensitizing to the skin of human volunteers.

By applying the weight of evidence approach, the test chemical can be considered to be not sensitizing to skin. Comparing the annotations with criteria of CLP regulation, the test chemical can be classified under the category "Not Classified".

 

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

By applying the weight of evidence approach, the test chemical can be considered to be not sensitizing to skin. Comparing the annotations with criteria of CLP regulation, the test chemical can be classified under the category "Not Classified".