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EC number: 911-238-8 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23 Nov 2009 to 3 Feb 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Fully guideline compliant
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- (1R,4aR,4bR,10aR)-1,4a-dimethyl-7-(propan-2-yl)-1,2,3,4,4a,4b,5,6,10,10a-decahydrophenanthrene-1-carboxylic acid; (1R,4aR,4bS,10aR)-1,4a-dimethyl-7-(propan-2-yl)-1,2,3,4,4a,4b,5,6,7,8,10,10a-dodecahydrophenanthrene-1-carboxylic acid; (1R,4aR,4bS,10aR)-1,4a-dimethyl-7-(propan-2-yl)-1,2,3,4,4a,4b,5,6,7,9,10,10a-dodecahydrophenanthrene-1-carboxylic acid; (1R,4aR,4bS,10aR)-1,4a-dimethyl-7-(propan-2-yl)-1,2,3,4,4a,4b,5,6,8a,9,10,10a-dodecahydrophenanthrene-1-carboxylic acid; (1R,4aS,10aR)-1,4a-dimethyl-7-(propan-2-yl)-1,2,3,4,4a,5,6,7,8,9,10,10a-dodecahydrophenanthrene-1-carboxylic acid; (1R,4aS,10aR)-1,4a-dimethyl-7-(propan-2-yl)-1,2,3,4,4a,9,10,10a-octahydrophenanthrene-1-carboxylic acid
- EC Number:
- 911-238-8
- Molecular formula:
- C20H28O2
- IUPAC Name:
- (1R,4aR,4bR,10aR)-1,4a-dimethyl-7-(propan-2-yl)-1,2,3,4,4a,4b,5,6,10,10a-decahydrophenanthrene-1-carboxylic acid; (1R,4aR,4bS,10aR)-1,4a-dimethyl-7-(propan-2-yl)-1,2,3,4,4a,4b,5,6,7,8,10,10a-dodecahydrophenanthrene-1-carboxylic acid; (1R,4aR,4bS,10aR)-1,4a-dimethyl-7-(propan-2-yl)-1,2,3,4,4a,4b,5,6,7,9,10,10a-dodecahydrophenanthrene-1-carboxylic acid; (1R,4aR,4bS,10aR)-1,4a-dimethyl-7-(propan-2-yl)-1,2,3,4,4a,4b,5,6,8a,9,10,10a-dodecahydrophenanthrene-1-carboxylic acid; (1R,4aS,10aR)-1,4a-dimethyl-7-(propan-2-yl)-1,2,3,4,4a,5,6,7,8,9,10,10a-dodecahydrophenanthrene-1-carboxylic acid; (1R,4aS,10aR)-1,4a-dimethyl-7-(propan-2-yl)-1,2,3,4,4a,9,10,10a-octahydrophenanthrene-1-carboxylic acid
- Details on test material:
- - Name of test material (as cited in study report): Resin 835 A
- Chemical name : Dehydrogenated/partially hydrogenated gum
- Lot/batch No.: K49E09-01999.
- Stability under test conditions: Stable
- Storage condition of test material: Room temperature. Storage in the dark but may be used under light.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH, D-88353 Kisslegg
- Age at study initiation: approximately 9 weeks
- Weight at study initiation: 2.2, 2.4 and 2.6 kg
- Housing: Individual caging in terulan cages, Ehret GmbH, A-3430 Tulln, 73 cm x 73 cm bottom area, 50 cm height
- Diet (e.g. ad libitum): Ssniff K-H maintenance diet for rabbits (item V-2333-000), ad libitum, supplied by Ssniff Spezialdiäten GmbH, 59494 Soest, Germany. Analysis of the feed for ingredients and contaminants is performed randomly by Ssniff. Hay-briquettes (from the same source as the feed) are offered additionally as a dietary supplement.
- Water (e.g. ad libitum): Tap water from an automatic watering system, ad libitum. Random samples of the water are analysed by the "AGES", A-1226 Vienna, to check, if the water fulfils the requirements for drinking water for humans.
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Average of about 20.0 °C (continuous control and recording)
- Humidity (%): Average of 30 - 70 % (continuous control and recording)
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 30 Nov 2009 To: 4 Dec 2009
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped with a hair clipper, Aesculap GH 204 with a 1 mm cutterhead
- Vehicle:
- other: 0.5 g test substance were moistened with 1.0 mL deionised water
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 g
VEHICLE
- Amount(s) applied: 1.0 mL deionised water for moistening - Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 hrs
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: gauze patches (Pur Zellin-Tupfer, obtained by Fa. Hartmann , A-2355 Wiener Neudorf) in a size of about 2.5 cm x 2.5 cm, held in place by fixing them marginally with non irritating tapes (Blenderm ®" surgical tape, hypoallergenic, 3M, Medical Products Division, St. Paul, MN 551444, USA). The application sites were covered semi-occlusively by a dressing (self adhesive non woven fabric, hypoallergenic, made by Beiersdorf AG, D-20245 Hamburg). Access by the animals to the application sites was prevented by a plastic collar.
REMOVAL OF TEST SUBSTANCE
- Washing: none
- Time after start of exposure: 4 hrs
SCORING SYSTEM:
Erythema / Eschar formation
0 No erythema.
1 Very slight erythema (barely perceptible).
2 Well-defined erythema.
3 Moderate to severe erythema.
4 Severe erythema (beet redness) or eschar formation (injuries in depth).
Oedema formation
0 No oedema.
1 Very slight oedema (barely perceptible).
2 Slight oedema (edges of area well defined by definite raising).
3 Moderate oedema (raised approximately 1 mm).
4 Severe oedema (raised more than 1 mm and extending beyond area of exposure).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 1, 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 1, 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- All areas to be treated with the test substance and all control areas were normal before the application and at each observation time.
- Other effects:
- 2/3 animals gained weight in the week p.a., 1/3 animals gained no weight in the week p.a.
Any other information on results incl. tables
Scores of the application site. Individual data and means
Time after the end of the exposure |
Erythema / Eschar animal Nos. |
Oedema animal Nos. |
||||
81 |
82 |
83 |
81 |
82 |
83 |
|
1 h |
0 |
0 |
0 |
0 |
0 |
0 |
24 h |
0 |
0 |
0 |
0 |
0 |
0 |
48 h |
0 |
0 |
0 |
0 |
0 |
0 |
72 h |
0 |
0 |
0 |
0 |
0 |
0 |
mean (24-72 h) |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- According to Commission Directive 2001/59/EC "RESIN 835 A" does not require classification for skin irritation.
- Executive summary:
Methods and investigations were performed in accordance with the OECD Guideline 404 and the Council Regulation (EC) No 440/2008, Method B.4.
Administration of the test substance
0.5 g "RESIN 835 A", moistened with deionised water, was applied via a patch to a site of 2.5 cm x 2.5 cm of the intact skin of each of 3 New Zealand White rabbits and covered by a semi-occlusive dressing.
The duration of the exposure was 4 hours.
Due to a prior performed EpiDerm Skin Corrosivity/Irritation Test (internal study code ACH35/ACH36) no skin corrosion or irritation was observed. Therefore the test substance was administered to the three animals simultaneously.
Investigations
· Body weights: at the start and at the termination of the test.
· General signs of toxicity: once daily.
· Skin examinations: 1, 24, 48 and 72 h after patch removal (p.a.).
Results
General signs of toxicity
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Skin examinations
· Erythema/Eschar: Not observed at any observation point.
· Oedema: Not observed at any observation point.
Conclusion
The following mean scores were calculated for each animal from the examinations 24 h,
48 h and 72 h p.a.:Mean Scores for Animal No.:
81
82
83
Erythema / Eschar
0.0
0.0
0.0
Oedema
0.0
0.0
0.0
According to Commission Directive 2001/59/EC "RESIN 835 A" does not require classification for skin irritation.
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