Registration Dossier
Registration Dossier
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EC number: 236-415-0 | CAS number: 13360-63-9
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: Significant methodological deficiencies (corrosive test material caused skin necrosis; low number of animals)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- ; low number of animals; test material injections cause dnecrosis
- Principles of method if other than guideline:
- Method: other: Magnusson/Kligman, J. Invest. Derm., 52(3), 268-276, 1969
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Butyl(ethyl)amine
- EC Number:
- 236-415-0
- EC Name:
- Butyl(ethyl)amine
- Cas Number:
- 13360-63-9
- Molecular formula:
- C6H15N
- IUPAC Name:
- butyl(ethyl)amine
- Details on test material:
- - Name of test material (as cited in study report): N-Ethly-NButylamine [CAS No. 13360-63-9], not further specified
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal
- Vehicle:
- other: isopropyl alcohol
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: isopropyl alcohol
- No. of animals per dose:
- Main study:
10 treated animals
4 control animals - Details on study design:
- 1st application: Induction 1 % active substance intracutaneous
2nd application: Induction 10 % active substance occlusive epicutaneous
3rd application: Challenge 1 % active substance occlusive epicutaneous
Results and discussion
Any other information on results incl. tables
RS-Freetext:
The maximum reaction scores after challenge were 1 and did not exceed those found in the control group.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- The TS produced no skin sensitisation, but the study is considered to be invalid.
- Executive summary:
The test substance produced no skin sensitisation under test conditions. N-ethyl-n-butylamineamine was graded as a "weak sensitiser" based on the ranking list presented (Safepharm, 1980).
The grading is unclear. The small group sizes do not allow to draw firm conclusions on the presence or absence of a weak sensitising potential. The group sizes were not adjusted to the low reaction to be expected, and were too low compared to the OECD test guideline. Furthermore, the absence of a positive control limits the reliability of the study.
Overall the study is not considered to be valid and useful for assessment. The test substance is corrosive to the skin, and a skin sensitisation study is therefore obsolete.
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