Registration Dossier

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Not applicable
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted similar or equivalent to guideline/s and GLP .
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2001

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes
Type of study:
mouse local lymph node assay (LLNA)

Test material

Constituent 1
Chemical structure
Reference substance name:
2,2'-iminodi(ethylamine)
EC Number:
203-865-4
EC Name:
2,2'-iminodi(ethylamine)
Cas Number:
111-40-0
Molecular formula:
C4H13N3
IUPAC Name:
bis(2-aminoethyl)amine
Details on test material:
Source: UCC Number 17002299

In vivo test system

Test animals

Species:
mouse
Strain:
Balb/c
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Seralab, Bicester, Oxfordshire, UK
- Housing: Mice were housed in groups of 1, 4 or 5 in metal cages
- Diet: ad libitum
- Water: ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 2°C
- Humidity (%): 55 +/-10%
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle.


Study design: in vivo (LLNA)

Vehicle:
other: 4:1 acetone:olive oil (AOO) or in AOO diluted with saline or water
Concentration:
2.5, 5 or 10%
No. of animals per dose:
4
Details on study design:
Groups of mice (n = 1 for siting studies, n = 4 for dose response studies) received 25ul of test material in vehicle or an equal volume of vehicle alone on the dorsum of both ears daily for 3 consecutive days. A further group of control animals was untreated (naïve). Five days after the initiation of exposure, all mice received an intravenous injection of 250ml of phosphate buffered saline (PBS) containing 20mCi of 3H-methyl thymidine (3H-TdR specific activity 2Ci/mmol; supplied by Amersham International, UK). Five hours later mice were sacrificed and the draining auricular lymph nodes removed and pooled for each experimental group.

A single cell suspension of lymph node cells (LNC) was prepared by mechanical disaggregation through a 200-mesh stainless steel gauze. Pooled LNC were washed twice with an excess of PBS and precipitated with 5% trichloroacetic acid (TCA) at 4°C. Approximately 12 hours later pellets were resuspended in 1ml of TCA and transferred to 10ml of scintillation fluid. Incorporation of 3HTdR was measured by b-scintillation counting and expressed as mean disintegrations per minute (dpm) per node for each test group. In each case, a stimulation index (SI) relative to the concurrent vehicle-treated control was derived. Chemicals which induce an SI of three or more are considered to be positive in this assay.
Positive control substance(s):
not specified
Statistics:
For each chemical, a stimulation index (SI) relative to the concurrent vehicle-treated control was derived. Chemicals which induce an SI of three or more are considered to be positive in this assay.

Results and discussion

Positive control results:
Not applicable.

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Remarks on result:
other: Naives: 1.2 AOO: 1.0 2.5%: 2.6 5%: 3.3 10%: 3.5 EC3: 3.9 (Concentration of material required to induce a stimulation index of 3, derived mathematically by linear interpolation)
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: Naives: 449 AOO: 370 2.5%: 950 5%: 1213 10%: 1303

Any other information on results incl. tables

DETA: Possesses contact allergic potential (positive in the local lymph node assay).

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information
Conclusions:
DETA tested in the standard AOO vehicle induced a positive response in the LLNA, with a SI of greater than 3 achieved at one or more test concentrations. A clear dose response effect was observed. Exposure to DETA provoked the lowest increases in radiolabelled thymidine incorporation observed, reaching stimulation indices of 3.3 and 3.5 at 5% and 10%, respectively. Due to local irritation, higher concentrations of this chemical could not be used.
Executive summary:

The dermal sensitization capability of a series of ethyleneamines were examined in the Local Lymph Node Assay. DETA: Possesses contact allergic potential (positive in the local lymph node assay).