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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:
key study
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:
Monographs of Fragrance Raw Materials – Phenethyl methyl ether
Author:
D.L.J Opdyke
Year:
1982
Bibliographic source:
Food and Chemical Toxicology, 1982

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Human Maximization test
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:
Currently no LLNA study is available for assessment. The Guinea Pig Maximization Test (GPMT) has been carried out as an animal test to predict human sensitization for over a decade and is recommended by international test guidelines such as OECD.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
- Name of test material: Benzene(-2-methoxyethyl)
- Molecular formula: C9H12O
- Molecular weight: 136.193 g/mole
- Smiles : COCCc1ccccc1
- Inchl: InChI=1/C9H12O/c1-10-8-7-9-5-3-2-4-6-9/h2-6H,7-8H2,1H3
- Substance type: Organic
- Physical state: Liquid

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:
8% in petrolatum
Day(s)/duration:
no data available
Adequacy of induction:
not specified
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
8% in petrolatum
Adequacy of challenge:
not specified
No. of animals per dose:
24 hours
Details on study design:
No data available
Challenge controls:
No data available
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Results
Key result
Reading:
1st reading
Group:
test group
Dose level:
8% in petrolatum
No. with + reactions:
0
Total no. in group:
24
Clinical observations:
no signs of dermal reactions observed
Remarks on result:
no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
other: not sensitizing
Conclusions:
The test chemical 8% in petrolatum did not induce any sensitization reactions on the skin of 24 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 8% in petrolatum was applied to the skin of 24 human volunteers and observed for signs of dermal sensitization (duration of exposure, observation period not specified).

The test chemical 8% in petrolatum did not induce any sensitization reactions on the skin of 24human volunteers.

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