Registration Dossier
Registration Dossier
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EC number: 216-133-4 | CAS number: 1506-02-1
Additional toxicological data
Administrative data
- Endpoint:
- additional toxicological information
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12-16 January 1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: No GLP study. There is no standardized protocol for conducting photoirritancy screening in humans. The laboratory used its own protocol.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
- Type of study / information:
- Photo irritancy
- Principles of method if other than guideline:
- The photoirritancy was tested on 10 human volunteers. AHTN was applied to several sites on the skin. Part of the sites were irradiated and the other sites non-irradiated. The skin evaluated at different time intervals. A positive control was also employed.
- GLP compliance:
- no
Test material
- Reference substance name:
- 1-(5,6,7,8-tetrahydro-3,5,5,6,8,8-hexamethyl-2-naphthyl)ethan-1-one
- EC Number:
- 216-133-4
- EC Name:
- 1-(5,6,7,8-tetrahydro-3,5,5,6,8,8-hexamethyl-2-naphthyl)ethan-1-one
- Cas Number:
- 1506-02-1
- Molecular formula:
- C18H26O
- IUPAC Name:
- 1-(5,6,7,8-tetrahydro-3,5,5,6,8,8-hexamethyl-2-naphthyl)ethan-1-one
- Details on test material:
- Tonalid
Constituent 1
Results and discussion
Any other information on results incl. tables
There were no significant reactions to the AHTN solution but all three subjects exposed to 8-MOP (positive control) showed clear positive reactions.Applicant's summary and conclusion
- Conclusions:
- AHTN is not photo-irritant to humans.
- Executive summary:
AHTN (Tonalid®; non-GLP, purity >98% - 10% dilution in ethanol/DEP (3:1)) was tested for photoirritancy on 10 female human volunteers (white Caucasian; ages 18-39). Before application of the preparation for each of the subjects, the Minimal Erythemal Dose (MED) was determined using UV light irradiation from a xenon arc solar light simulator. Subsequently, areas on the back were stripped 3 times to remove the superficial stratum corneum; followed by application of 20μL of the test solution to 3 designated test sites, each approximately 1.5 cm in diameter. One of the sites was used as the non-irradiated control site and one site was irradiated but was not treated with AHTN. In addition, three of the 10 subjects were randomly selected and treated with 20μL of a 0.2 mg/ml solution of 8-methoxypsoralen in ethanol as a positive control. After 30 min of contact, one AHTN-treated site and the site not treated with AHTN were irradiated with 10 MED of UV-A followed by 0.5 MED of UVA + UVB The sites were scored 5 min after irradiation and again at 3, 24, 48 and 73 hr after irradiation. There were no significant reactions to the AHTN solution but all three subjects exposed to 8-MOP showed clear positive reactions.
Source: EU Risk Assessment Report AHTN, ECB May 2008
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