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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:
May 31 - June 21, 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Qualifier:
according to
Guideline:
EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
Qualifier:
according to
Guideline:
EPA OPPTS 870.2600 (Skin Sensitisation)
GLP compliance:
yes (incl. certificate)
Type of study:
mouse local lymph node assay (LLNA)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
Name: Formaldehyde, reaction product with ethylenediamine
CAS No.: 84066-92-2
Batch No.: PK280-61
Purity: 100%

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
female
Details on test animals and environmental conditions:
Species/strain: Mouse, e.g. CBA/CaOlaHsd
Source: e.g. Harlan Winkelmann GmbH, 33178 Borchen, Germany
Sex: female (nulliparous and non-pregnant)
Age at the beginning of the study: 8 – 12 weeks
Number of animals: 5 mice per group

Study design: in vivo (LLNA)

Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
Based on the results observed in the prescreen test the following test item concentrations were selected for the main study:
25%, 50% (each diluted with AOO 4:1, v/v) and 100% (undiluted test item).
The preparations were made immediately prior to each dosing.
No. of animals per dose:
3 test groups (3 different concentrations) and 1 negative control group (vehicle) were tested.

Results and discussion

In vivo (LLNA)

Results
Parameter:
SI
Remarks on result:
other: Each of the three tested concentrations exceeded the stimulation index of 3. The stimulation index at a concentration of 25% was 9.5 The stimulation index at a concentration of 50% was 12.9 The stimulation index at a concentration of 100% was 14.8

Any other information on results incl. tables

The EC3 value (estimated by linear interpolation) was calculated to be at a test item concentration of 6.51%.

Consequently, according to OECD 429 solutions or preparations containing more than 6.51% Formaldehyde, reaction product with ethylenediamine are expected to have a stimulation index of > 3 and are therefore considered to be dermal sensitisers.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (skin sensitising) based on GHS criteria
Remarks:
Migrated information
Conclusions:
Formaldehyde, reaction product with ethylenediamine are expected to have a stimulation index of >3 and are therefore considered to be dermal sensitisers.
Executive summary:

The EC3 value (estimated by linear interpolation) was calculated to be at a test item concentration of 6.51%.