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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 from peer reviewed journals

Data source

Reference
Reference Type:
publication
Title:
Fragrance monograph for the test chemical
Author:
D.L.J. Opdyke
Year:
1974
Bibliographic source:
Food and Cosmetics Toxicology. Vol. 12, Pg. 393, 1974

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: As mentioned below
Principles of method if other than guideline:
Human Maximization test was performed to determine the dermal sensitization potential of the test chemical
GLP compliance:
not specified
Type of study:
patch test
Justification for non-LLNA method:
No data available

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
- Name of test material (as cited in study report): para-Cresyl methyl ether- Molecular formula: C8H10O- Molecular weight: 122.166 g/mol- Substance type: organic - Physical state: Solid- InChI: 1S/C8H10O/c1-7-3-5-8(9-2)6-4-7/h3-6H,1-2H3-- Smiles: COc1ccc(C)cc1

In vivo test system

Test animals

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

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
2%
Adequacy of induction:
not specified
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
2%
Adequacy of challenge:
not specified
No. of animals per dose:
25 volunteers
Details on study design:
No data available
Challenge controls:
No data available
Positive control substance(s):
not specified

Study design: in vivo (LLNA)

Statistics:
No data available

Results and discussion

Positive control results:
No data available

In vivo (non-LLNA)

Results
Reading:
1st reading
Group:
test group
Dose level:
2%
No. with + reactions:
0
Total no. in group:
25
Clinical observations:
No skin sensitization reaction was observed
Remarks on result:
no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
other: Not sensitizing
Conclusions:
No skin sensitization reaction were observed in treated volunteers .Hence the test chemical was considered to be not sensitizing to humans.
Executive summary:

Human Maximization test was performed to determine the dermal sensitization potential of the test chemical

The test chemical 2% in petrolatum was applied to the skin of 25 human volunteers and observed for signs of sensitization(duration of exposure, observation period not mentioned).

No skin sensitization reaction were observed in treated volunteers .Hence the test chemical was considered to be not sensitizing to humans.