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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
publication
Title:
Extrapolating local lymph node assay EC3 values to estimate relative sensitizing potency
Author:
Ryan CA, Kern PS, Dearman RJ, Kimber I and Basketter DA
Year:
2007
Bibliographic source:
Cutaneous and Ocular Toxicology, 26, 135-145, 2007

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
3-aminopropyldimethylamine
EC Number:
203-680-9
EC Name:
3-aminopropyldimethylamine
Cas Number:
109-55-7
Molecular formula:
C5H14N2
IUPAC Name:
N,N-dimethylpropane-1,3-diamine
Test material form:
liquid

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 7 - 12 weeks

Study design: in vivo (LLNA)

Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
0.5; 1.0; 2.5; 5.0; 10.0%
No. of animals per dose:
a minimum of 4 animals

Results and discussion

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Value:
13.9
Test group / Remarks:
10% test substance
Parameter:
SI
Value:
3.5
Test group / Remarks:
5% test substance
Parameter:
SI
Value:
1.1
Test group / Remarks:
1.0% test substance
Parameter:
SI
Value:
1.3
Test group / Remarks:
0,5% test substance
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: Vehicle: 463 Test material: 0.5%: 597 1.0%: 486 2.5%: 1626 5.0%: 3223 10.0%: 6417

Any other information on results incl. tables

EC3: 2.2% (EC3 value derived by linear interpolation);

EC3: 2.3% (EC3 values derived by log-linear extrapolation).

Applicant's summary and conclusion

Interpretation of results:
Category 1 (skin sensitising) based on GHS criteria