Schiff bases, C11-14-tert-alkyl methylene

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

Earlier work on a low-irritant formaldehyde-amine reaction product resulted in positive findings. This is predictable and this study is provided to justify why further testing is not appropriate. Classification is Skin Sens 1

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2600 (Skin Sensitisation)

GLP compliance:

yes (incl. QA statement)

Type of study:

mouse local lymph node assay (LLNA)

Test material

Test material information

Constituent 1

Reference substance name:

Formaldehyde, reaction products with ethylenediamine

EC Number:

281-928-5

EC Name:

Formaldehyde, reaction products with ethylenediamine

Cas Number:

84066-92-2

IUPAC Name:

Formaldehyde, reaction products with ethylenediamine

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%.