Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: no information on GLP

Data source

Reference
Reference Type:
publication
Title:
Evaluation of skin sensitization and cross-reaction of 9 alkyleneamines
Author:
Leung, H.W. et al.,
Year:
1997
Bibliographic source:
J Toxicol Cut & Ocular Tox 16:189-195.

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
According to Magnusson Kligman Assay
GLP compliance:
not specified
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
water
Concentration / amount:
Intradermal induction 5%, Epicutaneous induction 10%, Epicutaneous challenge 10%
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
Intradermal induction 5%, Epicutaneous induction 10%, Epicutaneous challenge 10%
No. of animals per dose:
10 male and 10 female
Challenge controls:
Irritation control animals, five male and five female guinea pigs, received the same challenge procedures as in the definitive sensitization study, but did not have preceding intradermal and/or epicutaneous induction procedures

Study design: in vivo (LLNA)

Details on study design:
Groups of 10 male and 10 female guinea pigs each received 0.1 ml intradermal induction injections into 2 sites each of the clipped shoulder skin as follows: 50% (v/v) Freund's complete adjuvant (FCA) water emulsion, the test material or vehicle, and the test material in FCA/water emulsion or FCA/water emulsion. Epicutaneous inductions were conducted 7 days later. The test material was applied to a 2 x 4 cm filter paper, which was then placed on the test site and secured with tape. The patches were left in place for 48 h, after which they were removed and the skin wiped free of any excess test material.
Epicutaneous challenge was undertaken by applying 2 x 2 cm filter paper squares soaked in the ethylenediamine solution to a previously untreated site (right flank) 14 days after epicutaneous induction (i.e., 21 days from the start of the study). Patches were left in place for 24 h, and the sites inspected for signs of irritation 24-48 h after removal of the occlusive dressings.

Results and discussion

Any other information on results incl. tables

Skin responses were evaluated and scored. 45% of animals tested showed signs of sensitisation.

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information
Conclusions:
Ethylenediamine is sensitising.
Executive summary:

In a Guinea Pig Maximisation test ethylene diamine was a sensitiser. Cross sensitisation with other ethylene amine substances was observed.