Registration Dossier
Registration Dossier
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EC number: 226-603-0 | CAS number: 5435-64-3
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation, other
- Remarks:
- Human Test
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- Read across is applied to a structural analogue
Data source
Referenceopen allclose all
- Reference Type:
- secondary source
- Title:
- Derm., Vol. 47, 393-, 1960
- Author:
- Kligman A.M., J. Invest.
- Year:
- 1 960
- Bibliographic source:
- cited in Food Chem. Toxicol., Monographs, Vol. 26(4), 319-320, Vol. 26(4), 1988
- Reference Type:
- secondary source
- Title:
- Report to RIFM, 07.11. 1980,
- Author:
- Epstein W.L.,
- Year:
- 1 980
- Bibliographic source:
- cited in Food Chem. Toxicol., Monographs, Vol. 26(4), 319-320, Vol. 26(4), 1988
- Reference Type:
- secondary source
- Title:
- Contact Dermatitis, Vol. 1, 231-, 1975
- Author:
- Kligman A.M. & Epstein W.,
- Year:
- 1 975
- Bibliographic source:
- cited in Food Chem. Toxicol., Monographs, Vol. 26(4), 319-320, Vol. 26(4), 1988
Materials and methods
- Principles of method if other than guideline:
- Method: other: according to Kligman (1960), and Kligman & Epstein(1975)
- GLP compliance:
- no
- Type of study:
- other: Maximization test with human
Test material
- Reference substance name:
- 2-ethylhexanal
- EC Number:
- 204-596-5
- EC Name:
- 2-ethylhexanal
- Cas Number:
- 123-05-7
- Molecular formula:
- C8H16O
- IUPAC Name:
- 2-ethylhexanal
Constituent 1
In vivo test system
Test animals
- Species:
- human
- Strain:
- other: Human test
- Sex:
- male/female
- Details on test animals and environmental conditions:
- 27 Humans
Results and discussion
- Positive control results:
- 0
In vitro / in chemico
Results
- Parameter:
- other: 0 positive of 27 in total
- Value:
- 0
- Vehicle controls validity:
- not specified
- Negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
No positives amongst the 27 Humans tested (2% in petrolatum). The test substance was therefore considered not to be sensitizing.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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