Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
Freund's complete adjuvant test

Test material

Constituent 1
Chemical structure
Reference substance name:
2-(2-formyl-4-nitrophenoxy)hexanoic acid
EC Number:
608-880-3
Cas Number:
335153-21-4
Molecular formula:
C13H15NO6
IUPAC Name:
2-(2-formyl-4-nitrophenoxy)hexanoic acid

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
female
Details on test animals and environmental conditions:
11 females; females were nulliparous and non-pregnant. Group housing.. Ambient temperature @20°C with 30-70% humidity. 10-15 air exchanges per hour. 12 hourlight/dark cycle, full spectrum fluorescent lights.

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
cotton seed oil
Concentration / amount:
Neat concentration = 2g in 20ml cotton seed oil
Intradermal injection conc used 75% of the neat concentration.
Topical application conc used 100% neat concentration
Challengeopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
cotton seed oil
Concentration / amount:
Neat concentration = 2g in 20ml cotton seed oil
Intradermal injection conc used 75% of the neat concentration.
Topical application conc used 100% neat concentration
No. of animals per dose:
Primary irritation group consisted of 3 animals.
Main study: Induction by intradermal injection. 5 animals and a control group of 3 animals.
Challenge controls:
All animals were involved in the challenge.
Positive control substance(s):
not specified

Results and discussion

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
According to the scoring, this is a Grade 1 reaction and the test substance is classified as having weak allergic potential. This is not considered significant according to Magnusson and Kligman.
Executive summary:

According to the scoring, this is a Grade 1 reaction and the test substance is classified as having weak allergic potential. This is not considered significant according to Magnusson and Kligman.