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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
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:
publication
Title:
Evaluation of skin irritation potential for the test chemical
Author:
D. L. J. Opdyke
Year:
1979
Bibliographic source:
Food and Cosmetics Toxicology 1979
Reference Type:
publication
Title:
Evaluation of skin irritation potential of 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 irritation potential of test material on 26 male volunteers.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 : C10H18O
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

Test animals

Species:
other: Human
Strain:
not specified
Details on test animals and environmental conditions:
No data available

Test system

Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
other: petrolatum
Controls:
not specified
Amount / concentration applied:
10% in petrolatum
Duration of treatment / exposure:
48 h
Observation period:
48 h
Number of animals:
26 human male volunteers.
Details on study design:
Test site: Back

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
48 h
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No irritation reaction were observed on 26 human male volunteers.

Applicant's summary and conclusion

Interpretation of results:
other: Not skin irritating
Conclusions:
Test material was considered to be not skin irritating in a pre test for human maximization assay.

Executive summary:

 

A pre-test for human maximization was performed to assess the dermal irritation potential of test chemical. The test chemical 10% in petrolatum was applied to the back of 26 male volunteers in a closed patch for 48 hours. The volunteers were observed for signs of irritation. No signs of irritation were noted in the volunteers after 48 hours. Hence, test material was considered to be not skin irritating in a pre test for human maximization assay.