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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
Data is from secondary source

Data source

Reference
Reference Type:
secondary source
Title:
To estimate skin sensitization potential of test chemical in albino guinea pigs
Author:
U.S. Environmental Protection Agency
Year:
2003
Bibliographic source:
U.S. Environmental Protection Agency,2003

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: as mentioned below
Principles of method if other than guideline:
To estimate skin sensitization potential of test chemical in albino guinea pigs
GLP compliance:
not specified
Type of study:
other: Modified Landsteiner
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

Constituent 1
Reference substance name:
2,6-xylenol
EC Number:
209-400-1
EC Name:
2,6-xylenol
Cas Number:
576-26-1
IUPAC Name:
2,6-dimethylphenol
Test material form:
solid
Details on test material:
Details on test material
- Name of test material (as cited in study report): 2,6-xylenol
- Molecular formula : C8H10O
- Molecular weight : 122.166 g/mol
- Substance type:organic
- Physical state:solid

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: albino
Sex:
not specified
Details on test animals and environmental conditions:
no data

Study design: in vivo (non-LLNA)

Induction
Route:
other: epicutaneous
Vehicle:
not specified
Concentration / amount:
single dose (concentration not mentioned)
Day(s)/duration:
not specified
Adequacy of induction:
not specified
Challenge
No.:
#1
Route:
other: epicutaneous
Vehicle:
not specified
Concentration / amount:
single dose (concentration not mentioned)
Day(s)/duration:
after rest period of 13 days
Adequacy of challenge:
not specified
No. of animals per dose:
no data
Details on study design:
Details on study design
RANGE FINDING TESTS:

MAIN STUDY
A. INDUCTION EXPOSURE
- Concentrations:Single dose


B. CHALLENGE EXPOSURE
- Day(s) of challenge:after rest period of 13 days
- Concentrations:Single dose
Challenge controls:
no data
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Group:
other: test material
Dose level:
no data
No. with + reactions:
0
Clinical observations:
no skin sensitizing effects were observed in treated animals
Remarks on result:
no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
other: not sensitizing
Conclusions:
The test chemical was considered to be non-sensitizer to albino guinea pigs.
Executive summary:

The skin sensitization test was carried out in albino guinea pigs to determine the sensitization potential of test chemical by using Modified Landsteiner Method.

A single dose of test chemical was applied dermally on skin of each guinea pig during the induction phase.

After rest period of 13 days challenge was done .

It was observed that the guinea pigs did not exhibit sensitization response at challenge concentrations therefore the test material was considered to be non-sensitizing to the guinea pigs.