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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
study performed prior to the implementation of REACH and thus at a time when the LLNA was not the only preferred method for skin sensitising potential assessment.

Test material

Constituent 1
Chemical structure
Reference substance name:
Ethylenediamine, propoxylated
EC Number:
500-035-6
EC Name:
Ethylenediamine, propoxylated
Cas Number:
25214-63-5
Molecular formula:
(C3H6O)n (C3H60)n (C3H6O)n(C3H6O)n C2H8N2 sum of n: >1 - 8.5
IUPAC Name:
Ethylenediamine, propoxylated
Details on test material:
Name: Ethylenediamine, propoxylated mw 480 (NLP)
Physical state: clear, yellowish, viscous liquid
Purity: > 99%

In vivo test system

Test animals

Species:
guinea pig
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS: guinea pig
- Strain: Hsd Poc:DH (SPF)
- Sex: female
- Source: Harlan Winkelmann GmbH, Borchen, GER
- Age: about 7 weeks
- Weight at study initiation: 337 g - 363 g
- Number of animals: 10 treated
- Controls: 5 animals

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal
Vehicle:
physiological saline
Challenge
Route:
epicutaneous, occlusive
Vehicle:
physiological saline
No. of animals per dose:
15
Details on study design:
1st application: Induction 5 % intracutaneous
2nd application: Induction undiluted occlusive epicutaneous
3rd application: Challenge undiluted occlusive epicutaneous

ADMINISTRATION/EXPOSURE
- Formulation of test substance for induction: 0.9% aqueous NaCl-solution
- Induction schedule: Intradermal induction using adjuvant technique on day 0. Occlusive epicutaneous induction with undiluted TS 7 days thereafter
- Concentration in Freuds Complete Adjuvant (FCA): TS 5% in Freund's adjuvant / 0.9% aqueous NaCl-solution (1:1)
- Challenge schedule: day 21 after untradermal induction
- Concentrations used for challenge: undiluted
- Positive controls: historical data

EXAMINATIONS
- Grading system: scale of Magnusson and Kligman
- Evaluation of skin reactions: The number of animals with skin findings at 24 and/or 48 hours after the removal of the patch was taken into account for the determination of the sensitization rate. The evaluation "sensitizing" results if at least 30 per cent of the test animals exhibit skin reactions in this adjuvant test.

- Pilot study: yes

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.5 ml of test substance
No. with + reactions:
0
Total no. in group:
9
Clinical observations:
One animal from the test group was terminated due to rectal prolaps on study day 9.
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.5 ml of test substance. No with. + reactions: 0.0. Total no. in groups: 9.0. Clinical observations: One animal from the test group was terminated due to rectal prolaps on study day 9..
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.5 ml of test substance
No. with + reactions:
0
Total no. in group:
9
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.5 ml of test substance. No with. + reactions: 0.0. Total no. in groups: 9.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 5.0.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
There was no evidence that TS caused skin hypersensitivity in the guinea pig, since no responses were observed in the experimental animals following the challenge.

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