Registration Dossier
Registration Dossier
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EC number: 608-880-3 | CAS number: 335153-21-4
Skin sensitisation
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:
- 2 002
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
- 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
Constituent 1
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.
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