Registration Dossier
Registration Dossier
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EC number: 201-234-8 | CAS number: 79-92-5
Skin irritation / corrosion
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:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Camphene
- EC Number:
- 201-234-8
- EC Name:
- Camphene
- Cas Number:
- 79-92-5
- Molecular formula:
- C10H16
- IUPAC Name:
- 2,2-dimethyl-3-methylidenebicyclo[2.2.1]heptane
- 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.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system 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
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- 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.
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