Registration Dossier

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Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report date:
2008

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no

Test material

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
female

Results and discussion

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Remarks on result:
other: see Remark
Remarks:
Concentration (% w/v) Stimulation index Result 0 1.0 - 10 1.1 negative 25 2.2 negative 50 1.9 negative
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: see Remark
Remarks:
Concentration (% w/v) Disintegrations per minute 0 4137.1 10 4562.3 25 9113.3 50 7877.1

Any other information on results incl. tables

No signs of irritation were observed after application of a 10%, 25% and 50% concentration of EEA-NH4.

3H-thymidine incorporation in the auricular lymph nodes in animals treated with a 10% concentration EEA-NH4 was similar to that in vehicle control animals, whereas3H‑thymidine incorporation was statistically significantly enhanced at 25% and 50% concentrations. Stimulation indices (SI’s) of 1.1, 2.2 and 1.9 were calculated in response to a 10%, 25% and 50% EEA-NH4 concentration respectively. Since the SI’s were lower than 3 at all concentrations the results indicated that EEA-NH4 should not be considered a skin sensitiser (a SI of 3 is the limiting value required for classification as a skin sensitiser).

Applicant's summary and conclusion