Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From: 01.11.1988 To: 04.11.1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Test method according to OECD guideline 404 and GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Camphen
- Substance type: solid
- Physical state: colorless, clear, vaseline-similar
- Analytical purity: 78,4 %
- Purity test date: 26.11.1987
- Lot/batch No.: 112
- Storage condition of test material: In the dark, at 4 ºC in the refrigerator.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG, Box reason, conventional breeding
- Age at study initiation: ca. 3 - 5 Months old
- Weight at study initiation: 2.4 - 3.1 kg
- Housing: Individually housed in battery cages in air-conditioned rooms.
- Diet (e.g. ad libitum): Altromin 2123 maintenance diet - Rabbits, Altromin GmbH, Lage / Lippe, ad libitum, and hay (about 15 grams daily).
- Water (e.g. ad libitum): Deionized, chlorinated water from automated drank, ad libitum.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 ºC
- Humidity (%): 50 ± 20 %
- Photoperiod: 12 hrs dark / 12 hrs light

IN-LIFE DATES: From: 01.11.1988 To: 04.11.1988

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: polyethylene glycol 400
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg per patch

VEHICLE
- Amount(s) applied (volume or weight with unit): 500 mg of camphene as a paste with 0.35 mL of polyethylene glycol 400 (Ch-B, 2322, applied Riedel de Haen AG)].
Duration of treatment / exposure:
Exposure time: 4 hours
Observation period:
72 hours
Number of animals:
3 animals
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The remaining test substance was carefully removed with warm tap water from the skin.
- Time after start of exposure: 4 hours

SCORING SYSTEM: The assessments were made 30 - 60 minutes and 24, 48 and 72 hours after the patch. The erythema and eschar and edema were evaluated numerically.
Erythema and eschar scoring:
No erythema ............................................................... 0
Very slight erythema (barely perceptible) ............. 1
Clearly circumscribed erythema ............................. 2
Medium to severe erythema ..................................... 3
Severe erythema (severe Rotung) to slight eschar formation (deep wounds )...............4
Oedema scoring:
No edema ..................................................................... 0
Very slight edema (hardly noticeable) ..................... 1
Slight edema (edges of the body are clearly defined by a distinct swelling)..................... 2
Middle edema (swelling of about 1 mm) .................. 3
Severe edema (swelling of more than 1 mm) over the exposure range beyond............... 4

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 72 h
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Irritant / corrosive response data:
No irritant nor corrosive reactions were observed in any treated animal.

Any other information on results incl. tables

No irritant nor corrosive reactions were observed in any treated animal.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
No irritant nor corrosive reactions were observed in any treated animals.
Executive summary:

This study has been carried out with the aim of evaluating the possible irritant / corrosive effects of the product Camphene on the skin, using White New Zealand rabbits (no data on sex). The test method was according to OECD guideline 404 and GLP. A dose level of 500 mg was applied to a skin area of 2.5 x 2.5 cm in three rabbits for 4 hours. During the assay period, environmental conditions remained constant (Temperature: 20 ± 3 ºC, Humidity: 50 ± 20 % and Photoperiod: twelve hours light and twelve hours darkness).

The degree of irritation was daily registered for three days to be later scored in order to make a whole assessment of the effects.

No irritant nor corrosive reactions were observed in any treated animal.