Registration Dossier

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:
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

Reference
Name:
Unnamed
Type:
Constituent
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.