Registration Dossier
Registration Dossier
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EC number: 701-188-3 | CAS number: -
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2006-01-17 to 2006-01-31
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP study following OECD guideline, well conducted and documented, including certificate of analysis.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- (R)-α,α,4-trimethylcyclohex-3-ene-1-methanol
- EC Number:
- 232-081-5
- EC Name:
- (R)-α,α,4-trimethylcyclohex-3-ene-1-methanol
- Cas Number:
- 7785-53-7
- Molecular formula:
- C10H18O
- IUPAC Name:
- α,α-4-trimethyl-(1R)-3-cyclohexene-1-methanol
- Reference substance name:
- p-menth-1-en-8-ol
- EC Number:
- 233-986-8
- EC Name:
- p-menth-1-en-8-ol
- Cas Number:
- 10482-56-1
- Molecular formula:
- C10H18O
- IUPAC Name:
- α,α-4-trimethyl-(1S)-3-cyclohexene-1-methanol
- Reference substance name:
- 1-methyl-4-(1-methylethylidene)cyclohexan-1-ol
- EC Number:
- 209-584-3
- EC Name:
- 1-methyl-4-(1-methylethylidene)cyclohexan-1-ol
- Cas Number:
- 586-81-2
- Molecular formula:
- C10H18O
- IUPAC Name:
- 1-methyl-4-(1-methylethylidene)-cyclohexanol
- Reference substance name:
- cis-4-isopropenyl-1-methylcyclohexanol
- Cas Number:
- 7299-41-4
- Molecular formula:
- C10H18O
- IUPAC Name:
- cis-4-isopropenyl-1-methylcyclohexanol
- Reference substance name:
- 4-(isopropyl)-1-methylcyclohex-3-en-1-ol
- EC Number:
- 209-585-9
- EC Name:
- 4-(isopropyl)-1-methylcyclohex-3-en-1-ol
- Cas Number:
- 586-82-3
- Molecular formula:
- C10H18O
- IUPAC Name:
- 4-isopropyl-1-methyl-3-cyclohexen-1-ol
- Reference substance name:
- 1-methyl-4-[1-1-(1-methylethoxy)ethyl]-cyclohexene
- Cas Number:
- 27153-55-5
- Molecular formula:
- C13H24O
- IUPAC Name:
- 1-methyl-4-[1-1-(1-methylethoxy)ethyl]-cyclohexene
- Reference substance name:
- trans-1-methyl-4-(1-methylethenyl)-cyclohexanol
- Cas Number:
- 7299-40-3
- Molecular formula:
- C10H18O
- IUPAC Name:
- trans-1-methyl-4-(1-methylethenyl)-cyclohexanol
- Reference substance name:
- (1S-endo)-1,3,3-trimethylbicyclo[2.2.1]heptan-2-ol
- EC Number:
- 208-135-9
- EC Name:
- (1S-endo)-1,3,3-trimethylbicyclo[2.2.1]heptan-2-ol
- Cas Number:
- 512-13-0
- Molecular formula:
- C10H18O
- IUPAC Name:
- 1,3,3-trimethyl-(1S,2S,4R)-bicyclo[2.2.1]heptan-2-ol
- Reference substance name:
- 1,3,3-trimethyl-(1R,2R,4S)-bicyclo[2.2.1]heptan-2-ol
- Cas Number:
- 2217-02-9
- Molecular formula:
- C10H18O
- IUPAC Name:
- 1,3,3-trimethyl-(1R,2R,4S)-bicyclo[2.2.1]heptan-2-ol
- Reference substance name:
- (1S-endo)-1,7,7-trimethylbicyclo[2.2.1]heptan-2-ol
- EC Number:
- 207-353-1
- EC Name:
- (1S-endo)-1,7,7-trimethylbicyclo[2.2.1]heptan-2-ol
- Cas Number:
- 464-45-9
- Molecular formula:
- C10H18O
- IUPAC Name:
- 1,7,7-trimethyl-(1S,2R,4S)- bicyclo[2.2.1]heptan-2-ol
- Reference substance name:
- (1R,2S,4R)-borneol
- EC Number:
- 207-352-6
- EC Name:
- (1R,2S,4R)-borneol
- Cas Number:
- 464-43-7
- Molecular formula:
- C10H18O
- IUPAC Name:
- 1,7,7-trimethyl-(1R,2S,4R)-bicyclo[2.2.1]heptan-2-ol
- Test material form:
- liquid
- Details on test material:
- Batch No.: 049807
Purity: 67.2% (sum of the three main constituents)
Name of test material (as cited in study report): TERPINEOL MULTICONSTITUENT
Physical state: colourless liquid
Storage conditions: +2°C to +8°C, under nitrogen and protected from light
Expiry date: 30 November 2017
Constituent 1
Constituent 2
Constituent 3
impurity 1
impurity 2
impurity 3
impurity 4
impurity 5
impurity 6
impurity 7
impurity 8
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage Janvier, Le Genest St Isle, France
- Age at study initiation: approximately 6 weeks old
- Weight at study initiation: males between 228 g and 272 g, and females between 217g and 222 g
- Acclimatisation period: at least 5 days
- Housing: Five animals of the same sex are kept in each makrolon cage, dimensions 47 cm X 31 cm X 19 cm
- Diet (e.g. ad libitum): rats-mice maintenance pelleted diet (ad libitum)
- Water (e.g. ad libitum): tap water from public distribution system (ad libitum)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): between 19 and 25
- Humidity (%): between 30 and 50
- Air changes (per hr): at least 10 cycles
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 2006-01-17 To: 2006-01-31
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure:
- % coverage: 10% of the total body
- Type of wrap if used: porous gauze dressing and non-irritating tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): water
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): test group: 2.13 mL/kg body weight
- Concentration: undiluted
VEHICLE
- Amount(s) applied (volume or weight with unit): control group: 2 mL/kg body weight of distilled water - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Systemic examinations were carried out to identify behavioral or toxic effects on physiological functions at 1, 3, 5, 24 and 48 h after administration of the product. Animals were weighed on D0 before application of the product, D2, D7, and D14.
- Necropsy of survivors performed: yes, performed on D14 for the macroscopic examination of the following organs: oesopahgus, stomach, duodenum, jejunum, ileum, caecum, rectum, spleen, liver, thymus, trachea, lungs, heart, kidneys, urinary bladder, testicles, ovaries, uterus, adrenals, pancreas and treatment area (skin). - Statistics:
- no data
Results and discussion
- Preliminary study:
- No data
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No mortality
- Clinical signs:
- other: No systemic clinical signs were noted.
- Gross pathology:
- No significant toxic effects.
- Other findings:
- No data
Any other information on results incl. tables
No data
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Tthe LD50 of the test item DERTOL 90 is higher than 2000 mg/kg body weight. Therefore it should not be classified according to CLP Regulation (EC) No 1272/2008.
- Executive summary:
Acute dermal toxicity study of Terpineol multiconstituent as a limit test was conducted according to OECD guideline 402 and in compliance with GLP. To groups of 5 Sprague-Dawley rats/sex were used: one control group exposed to distilled water and one test group. The test substance was applied to the skin by topical application for 24 h, under semi-occlusive conditions, at 2000 mg/kg bw, with a volume of 2.13 mL/kg bw. After exposure, exposure area was washed with distilled water.
Animals were observed every day for systemic clinical signs and mortalities for 14 days. The animals were weighed on D0, D2, D7 and D14. Necropsies were done on D14 for macroscopic observations. No toxic effects were observed.
Based upon these experimental conditions, the LD50 of Terpineol multiconstituent is higher than 2000 mg/kg bw by dermal route in the rat,
and Terpineol multiconstituent should not be classified according to CLP Regulation (EC) No 1272/2008.
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