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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:
June/July 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
The study was performed in compliance with the following regulations or guidelines:
• OECD Guideline for the Testing of Chemicals No. 429 "Skin Sensitization : Local Lymph Node Assay (adopted 22 July 2010)
° Method B42 Skin Sensitization (Local Lymph Node Assay) of Commission Regulation (EC) No. 440/2008

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report Date:
2016

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
Off white powder
Specific details on test material used for the study:
Batch 866462-52-4

In vivo test system

Test animals

Species:
mouse
Strain:
CBA/Ca
Sex:
not specified

Study design: in vivo (LLNA)

Vehicle:
propylene glycol
Concentration:
10%, 5% or 2.5% w/w
No. of animals per dose:
4
Details on study design:
Following a preliminary screening test in which no clinical signs of toxicity were noted at the concentration of 10% w/w, this concentration was selected as th highest dose investigated in the main test of the LLNA.
Three groups, each of four animals, were treated with 50μL (25μL per ear) of the test item as a suspension in propylene glycol at concentrations of 10%, 5% or 2.5% w/w. A further group of four animals was treated with propylene glycol alone.

Results and discussion

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Value:
ca. 2.92
Variability:
Negative
Test group / Remarks:
Concentration 2.5% in propylene glycol
Parameter:
SI
Value:
ca. 1.84
Variability:
Négative
Test group / Remarks:
Concentration 5% in propylene glycol
Key result
Parameter:
SI
Value:
ca. 5.14
Variability:
Positive
Test group / Remarks:
Concentration 10% in propylene glycol

Applicant's summary and conclusion

Interpretation of results:
Category 1 (skin sensitising) based on GHS criteria
Conclusions:
The test item was considered to be a sensitizer under the conditions of the test.
Executive summary:

The test item was considered to be a sensitizer under the conditions of the test.