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Toxicological information

Specific investigations: other studies

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Administrative data

Endpoint:
specific investigations: other studies
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The test comprised of an induction treatment of topical applications of a dilution of the test substance with 2% in ethanol followed by UV-irradiation, once daily on 5 consecutive days, and a challenge treatment, 10 days after the last induction consisting of one application with 2% in ethanol followed by UV-irradiation. During the induction phase, ten guinea pigs were treated with the test substance and 5 with ethanol. All animals were challenged with the test substance.
GLP compliance:
yes
Type of method:
in vivo
Endpoint addressed:
skin sensitisation

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Specific details on test material used for the study:
- Description: white, crystalline solid

Test animals

Species:
guinea pig
Strain:
other: Cpb:GpHi 65
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Central Institute for the Breeding of Laboratory Animals TNO, Zeist, the Netherlands
- Weight at study initiation: 235-310 g
- Housing: Individually under conventional conditions in suspended, stainless steel cages, fitted with wire mesh floor and front
- Diet: Pelleted, natural ingredient diet (Hope Farms, Woerden, The Netherlands), ad libitum
- Water: Unfluoridated tap water, ad libitum
- Acclimation period: 3 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18±2
- Humidity (%): 40-70
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
dermal
Vehicle:
ethanol
No. of animals per sex per dose:
- Test group: 10 - Control group: 5
Control animals:
yes, concurrent vehicle
Details on study design:
Induction: Induction was effected by topical treatment. For this purpose the dorsal neck region and the mid-dorsal region of the test and control animals were closely shaved with electric clippers. Shaving was repeated before each application or reading if necessary. The treatment consisted of applying 0.2 mL of a 2% solution of the test substance in ethanol (96%) to the dorsal neck region of each test animal once daily for 5 days. At the same time, 0.2 mL solvent was applied, as a control, to the mid-dorsal region of the test animals. The treated sites covered an area of about 2 x 3 cm. Control animals were similarly treated with 0.2 mL solvent only. After each application of the solvent and the test solution, the animals were placed together under a Philips UV fluorescent lamp (40 W/08, F40 T12 BLB, wave length of 310—420 nm), and then irradiated for 30 min at a distance of 37 cm from the lower side of the lamp.

Challenge: Topical challenge was carried out 10 days after the last topical induction as follows: The dorsal neck and mid-dorsal region of the guinea pigg was closely shaved again with electric clippers. Subsequently 0.2 mL of a 2% solution of the the substance in ethanol (96 %) was applied to the dorsal neck region of the test animals as well as of the control animals. At the same time, as a control, 0.2 mL solvent was applied to the mid-dorsal region of each animal. The treated sites covered an area of about 2 x 3 cm. Then all animals were exposed to UV irradiation for 30 min as described before.

Examinations

Examinations:
Induction: Skin readings were made 24 h after each daily treatment. The responses were given a score according to Draize et al. (1944).
Challenge: Skin readings were made after 24, 48 and 72 h.

Results and discussion

Details on results:
All animals remained in good health during the experimental period. During the five days of the induction period, a number of animals showed very slight erythema on the treated site after the 2nd, 4th and 5th application and irradiation. None of the control sites showed a positive response. Upon the challenge treatment with the 2% dilution of the test substance one out of ten test animals showed very slight erythema after 24, 48 or 72 hours.

Applicant's summary and conclusion