Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

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

Reference
Reference Type:
publication
Title:
Fragrance monograph of the test substance
Author:
D.L.J Opdyke
Year:
1975
Bibliographic source:
Food and Cosmetics Toxicology, 1975

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: as mentioned below
Principles of method if other than guideline:
A human maximization test was carried out to assess the dermal sensitization potential of the test chemical
GLP compliance:
not specified
Type of study:
other: human maximization test
Justification for non-LLNA method:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Camphene
EC Number:
201-234-8
EC Name:
Camphene
Cas Number:
79-92-5
Molecular formula:
C10H16
IUPAC Name:
Camphene
Test material form:
solid
Details on test material:
- Name of test material (as cited in study report):1,7,7-trimethylbicyclo[2.2.1]heptan-2-one- Molecular formula :C10H16- Molecular weight:136.236 g/mol- Substance type:Organic- Physical state:Solid

In vivo test system

Test animals

Species:
other: humans
Strain:
not specified
Sex:
not specified

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
4% in petrolatum
Adequacy of induction:
not specified
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
4% in petrolatum
Adequacy of challenge:
not specified
No. of animals per dose:
25 human volunteers
Details on study design:
No data available
Challenge controls:
No data available
Positive control substance(s):
not specified

Results and discussion

Positive control results:
No data available

In vitro / in chemico

Other effects / acceptance of results:
No data available

In vivo (non-LLNA)

Results
Reading:
1st reading
Group:
test chemical
Dose level:
4% in petrolatum
No. with + reactions:
0
Total no. in group:
25
Clinical observations:
No reactions observed
Remarks on result:
no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
other: not sensitizing
Conclusions:
The test chemicl 4% in petrolatum did not induce any sensitization reactions on the skin of 25 human volunteers.Hence, the test chemical was considered to be not sensitizing to skin.
Executive summary:

A human maximization test was carried out to assess the dermal sensitization potential of the test chemical.The test chemical 4% in petrolatum was applied to the skin of 25 human volunteers and observed for signs of dermal sensitization (duration of exposure, observation period not specified).

The test chemical 4% in petrolatum did not induce any sensitization reactions on the skin of 25 human volunteers.

Hence,the test chemical was considered to be not sensitizing to skin.