Registration Dossier
Registration Dossier
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EC number: 911-238-8 | CAS number: -
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 24 October 2003 to 11 February 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Fully Guideline- and GLP-compliant
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- 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 (Lot:0161852)
- Molecular formula (if other than submission substance): main component C20H28O2
- Molecular weight (if other than submission substance): main component 300 g/mol
- Physical state: solid melt
- Composition of test material, percentage (w/w) of components: 56 % dehydroabietic acid, 20 % dihydroabietic acid, 9.8 % neutral components, 9 % non ident. rosin acids, 4 % Pimaric acids
- Purity test date: 11 March 2003 and 4 September 2003
- Lot/batch No.: 0161852
- Expiration date of the lot/batch: 17 June 2004
- Storage condition of test material: at approx. 20 °C in a fume cupboard
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Gartenstrasse 27, 33178 Borchen, Germany
- Age at study initiation: 6 to 10 weeks
- Weight at study initiation (means): 256 g (males) and 222 g (females)
- Fasting period before study: no
- Housing: single caging, Macrolon cages type III on soft wood granulate
- Diet (e.g. ad libitum): ssniff R/M-H (V 1534), ad lib.
- Water (e.g. ad libitum): tap water, ad lib.
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 °C
- Humidity (%): 50 +/- 20 %
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 5 November 2003 To: 19 November 2003
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- other: sesame oil
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorsal skin
- coverage: 30 cm2
- Type of wrap if used: two-ply gauze, aluminium foil, elastic plaster bandage (Fixomull and Elastoplast)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm water
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied: 0.5 g
- Constant volume or concentration used: yes
- For solids, paste formed: moistened with 0.3 mL sesame oil
VEHICLE
- Amount(s) applied: 0.3 mL for moistening - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: twice daily (on weekends and holidays once daily); Weighing weekly
- Necropsy of survivors performed: yes - Statistics:
- no statistics performed
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- no mortality
- Clinical signs:
- other: no symptoms in any animal, no signs of skin irritation
- Gross pathology:
- no macroscopically visible changes
- Other findings:
- none
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Acute dermal toxicity testing of Resin 835 A (Lot:0161852) in the rat yielded a median lethal dose (LD50) above 2000 mg/kg body weight in both maleand female animals.
- Executive summary:
Acute dermal toxicity testing of Resin 835 A (Lot:0161852) in the rat yielded a median lethal dose (LD50) above 2000 mg/kg body weight in both male and female animals.
After administration of 2000 mg/kg body weight neither deaths nor symptoms occurred.
The skin of the animals showed no signs of irritation.
Development of body weight was not impaired in eight animals, the other two animals showed a slight loss of body weight in the first study week.
All animals were killed at the end of the observation period. They showed no macroscopically visible changes.
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