Registration Dossier
Registration Dossier
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EC number: 268-407-8 | CAS number: 68083-58-9
Specific investigations: other studies
Administrative data
- Endpoint:
- phototoxicity
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Test material at 5% in vaseline was applied to the skin of 10 test animals and 5 animals received the vehicle alone as a control. The treatment consisted of 0.5 g test material or vehicle plus suberythema UV irradiation. Skin reactions were observed after 2, 24 and 48 hours.
- GLP compliance:
- no
- Type of method:
- in vivo
- Endpoint addressed:
- other: Phototoxicity
Test material
- Reference substance name:
- 1,3-dimethyl-3-phenylbutyl acetate
- EC Number:
- 268-407-8
- EC Name:
- 1,3-dimethyl-3-phenylbutyl acetate
- Cas Number:
- 68083-58-9
- Molecular formula:
- C14H20O2
- IUPAC Name:
- 4-methyl-4-phenylpentan-2-yl acetate
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Lippische Versuchstierzucht Hagemann GmbH & Co. KG
- Weight at study initiation: mean: 200 g
- Housing: two animals in one tage (Macrolon Plastic cages III 14 cm high, 25 cm width, 42 cm length)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 °C +/- 2 °C
- Humidity (%): 50 - 85 %
- Photoperiod (hrs dark / hrs light):12 hours daily, from 7.00 a.m. to 7.00 p.m.
Administration / exposure
- Route of administration:
- dermal
- Vehicle:
- petrolatum
- Duration of treatment / exposure:
- 2 weeks
- Frequency of treatment:
- daily
- No. of animals per sex per dose:
- control: 5 animals
treatment group: 10 animals in total - Control animals:
- yes
- Details on study design:
- amount applied: 0.5g
Examinations
- Examinations:
- 2, 24 and 48 hours after application
Results and discussion
- Details on results:
- No skin reactions after 2, 24 or 48 hours.
Applicant's summary and conclusion
- Conclusions:
- Not phototoxic in guinea pigs
- Executive summary:
The test material, 1,3-dimethyl-3-phenylbutyl acetate at 5% in vaseline was applied to the skin of 10 test animals and 5 additional animals received the vehicle as control. The treatment consisted of a dose of 0.5 g test material (or vehicle) along with suberythemal UV irradiation. Skin was observed for reactions 2, 24 and 48 hours after application.
No skin reactions were observed in any of the 10 treated animals.
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