Registration Dossier

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 publication

Data source

Reference
Reference Type:
publication
Title:
skin sensitization potential of test chemical
Author:
D. L. J. Opdyke
Year:
1975
Bibliographic source:
Food and Cosmetics Toxicology,1975

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: as mentioned below
Principles of method if other than guideline:
To determine skin sensitization potential of test chemical in human using maximization test
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 Human Maximization test 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

In vivo test system

Test animals

Species:
human
Strain:
not specified
Sex:
not specified

Study design: in vivo (non-LLNA)

Induction
Route:
other: no data
Vehicle:
petrolatum
Concentration / amount:
2%
Adequacy of induction:
other: no skin sensitization reactions
Challenge
No.:
#1
Route:
other: no data
Vehicle:
petrolatum
Concentration / amount:
2 %
Adequacy of challenge:
other: no skin sensitization reactions
No. of animals per dose:
25
Details on study design:
no data
Challenge controls:
no data
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Group:
test group
Dose level:
2%
No. with + reactions:
0
Total no. in group:
25
Remarks on result:
other: no sensitization reactions.

Applicant's summary and conclusion

Interpretation of results:
other: not sensitising
Conclusions:
Since the test chemical did not cause any known signs of contact sensitization, it was considered as not sensitizing to human skin.
Executive summary:

Maximization test was performed in 25 human subjects to assess the skin sensitization potential of test chemical. The test chemical was applied dermally to the skin of human volunteers at a dose of 2% in petrolatum. Since the test chemical did not cause any known signs of contact sensitization, it was considered as not sensitizing to human skin.