Registration Dossier

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:
1984
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
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Details on test animals 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.