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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
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.

Data source

Referenceopen allclose all

Reference Type:
secondary source
Title:
Monographs on Fragrance Raw Materials
Author:
D. L. J. Opdyke
Year:
1979
Bibliographic source:
Food and Cosmetics Toxicology,1979
Reference Type:
publication
Title:
Monographs on Fragrance Raw Materials for test material
Author:
S.P. Bhatia et.al.
Year:
2008
Bibliographic source:
Food and Chemical Toxicology, (2008)

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: as mentioned below
Principles of method if other than guideline:
To evaluate skin sensitization potential for test material on 26 humane male volunteers.
GLP compliance:
not specified
Type of study:
other: Human maximization test
Justification for non-LLNA method:
Not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
IUPAC:Exo-1,7,7-trimethylbicyclo[2.2.1]heptan-2-ol
commen name:Isoborneol
EC No:204-712-4
Molecular weight: 154.2512 g/mol
molecular formula : C10-H18-O
Substance type: organic
Physical state: solid
Smiles :CC1(C)[C@@H]2CC[C@@]1(C)[C@H](O)C2
InChI :1S/C10H18O/c1-9(2)7-4-5-10(9,3)8(11)6-7/h7-8,11H,4-6H2,1-3H3/t7-,8-,10+/m1/s1


In vivo test system

Test animals

Species:
other: Human
Strain:
not specified
Sex:
male
Details on test animals and environmental conditions:
26 Human male volunteers were used.

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
10% (6900 µg/cm2)
Day(s)/duration:
5 days
Adequacy of induction:
not specified
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
Not specified
Day(s)/duration:
48 hrs
Adequacy of challenge:
not specified
No. of animals per dose:
26 human volunteers were used.
Details on study design:
A. INDUCTION EXPOSURE
- No. of exposures: 5
- Exposure period: 48h
- Test groups: 26 male
- Control group: not specified
- Site: forearms
- Frequency of applications: not specified
- Duration: five
alternate day

- Concentrations: 10% (6900 µg/cm2)

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 2 days
- Exposure period: 48 h
- Test groups: 26 male
- Control group: not specified
- Site: right side
- Concentrations: not specified
- Evaluation (hr after challenge): 48 hrs

OTHER: Patch sites were pre-treated for 24 h
with 5% aqueous sodium lauryl solution (SLS) under occlusion for the initial patch only in induction and 5% aqueous SLS under occlusion on the left side during challenge.
Challenge controls:
Not specified
Positive control substance(s):
yes
Remarks:
sodium lauryl solution (SLS)

Results and discussion

Positive control results:
Not specified

In vivo (non-LLNA)

Results
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
10% (6900 µg/cm2)
No. with + reactions:
0
Total no. in group:
26
Clinical observations:
No sensitization reactions were observed
Remarks on result:
no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
other: Not skin sensitizing
Conclusions:
No sensitization reaction were observed.Hence,test material was considered to be not sensitizing to skin.
Executive summary:

A maximization test (Kligman, 1966; Kligman and Epstein, 1975) was carried out with 10% (6900 µg/cm2) test material in petrolatum on 26 male volunteers. Test material was applied under occlusion to the same site on the forearms of 26 male subjects for five alternate day, 48-h periods. Patch sites were pre-treated for 24 h with 5% aqueous sodium lauryl solution (SLS) under occlusion for the initial patch only. After 10–14 day rest period, a challenge patch was applied to a fresh site for 48 h under occlusion.

Challenge applications were preceded by 30 minute applications of 5% aqueous SLS under occlusion on the left side whereas is test material was applied without SLS treatment on the right side. No sensitization reactions were observed. Hence, test material was considered to be not sensitizing to skin.