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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
12 March 2007 to 27 March 2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
GLP compliance:
yes
Type of study:
mouse local lymph node assay (LLNA)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: pale yellow solid block
Details on test material:
- Name of test material (as cited in study report): Dantocol DHE
- Physical state: pale yellow solid block
- Lot/batch No.: M5469330
- Storage condition of test material: room temperature in the dark

In vivo test system

Test animals

Species:
mouse
Strain:
CBA/Ca
Sex:
female

Study design: in vivo (LLNA)

Vehicle:
dimethylformamide
Concentration:
10%, 25% or 50% w/w
No. of animals per dose:
4/treatment group
Positive control substance(s):
not specified

Results and discussion

Positive control results:
Not specified.

In vivo (LLNA)

Resultsopen allclose all
Key result
Parameter:
SI
Value:
1
Test group / Remarks:
10%
Key result
Parameter:
SI
Value:
1.48
Test group / Remarks:
25%
Key result
Parameter:
SI
Value:
1.36
Test group / Remarks:
50%

Any other information on results incl. tables

There were no deaths and no signs of systemic toxicity were noted in the test or control animals during the test.

 Concentration (%w/w) in dimethyl formamide  Stimulation Index  Result
 Vehicle  N/A  N/A
 10 1.00   Negative
 25 1.48  Negative
  50 1.36  Negative

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The substance was considered to be a non-sensitiser based on a SI of less than 3 for all treatment groups.
Executive summary:

In an in vivo local lymph node assay to evaluate the sensitisation potential of the substance mice (4 animals/treatment group) were exposed to the substance for 3 consecutive days at concentrations 10%, 25% or 50% w/w. Another group of 4 animals received the vehicle alone. The SI for all treatment groups was below 3 and thus indicates that the substance is not a sensitiser.