Registration Dossier
Registration Dossier
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EC number: 470-680-5 | CAS number: 958872-63-4
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 16.01.2007 to 30.01.2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD guideline study no deviations GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- page 19 of attached report
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 470-680-5
- EC Name:
- -
- Cas Number:
- 958872-63-4
- Molecular formula:
- C16H30O3
- IUPAC Name:
- 1-[2-({1,7,7-trimethylbicyclo[2.2.1]heptan-2-yl}oxy)propoxy]propan-2-ol; 1-{[1-({1,7,7-trimethylbicyclo[2.2.1]heptan-2-yl}oxy)propan-2-yl]oxy}propan-2-ol; 2-[2-({1,7,7-trimethylbicyclo[2.2.1]heptan-2-yl}oxy)propoxy]propan-1-ol; 2-{[1-({1,7,7-trimethylbicyclo[2.2.1]heptan-2-yl}oxy)propan-2-yl]oxy}propan-1-ol
- Details on test material:
-
- Name of test material (as cited in study report): Dipropylenglykolisobornylether (isomerengemisch)
- Substance type: mixture of isomers
- Physical state: liquid
- Analytical purity: 97.9% (a/a)
- Impurities (identity and concentrations): as submited substance
- Composition of test material, percentage of components: as submited substance
- Isomers composition: as submited substance
- Lot/batch No.: V04/010-13N
- Expiration date of the lot/batch: 01.03.2008
- Storage condition of test material: ambient temperature
- Other: certificate of analysis Nº AZ-212, Clariant GmbH, Analytical services (23.03.2005)
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: Elevage Janvier (FR-53940 Le Genest St Isle)
- Age at study initiation: 7-8 weeks old
- Weight at study initiation: 233- 250 g (males) and 213- 225 g (females)
- Acclimation period:at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20ºC- 23ºC
- Humidity (%): 30- 65%
IN-LIFE DATES: From: 16 January 2007 To:30 January 2007
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- Topical application, under porous gauze dressing
- Duration of exposure:
- 24 h
- Doses:
- effective dose of 2000 mg/kg body weight under a volume of 2.05 mL/kg body weight.
- No. of animals per sex per dose:
- 10 group control (5 males and 5 females)
10 group treated (5 males and 5 females) - Control animals:
- yes, concurrent no treatment
- Details on study design:
- Control animals received distilled water under a volume of 2mL/kg body weight
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No mortality occured during the study
- Clinical signs:
- other: Neither cutaneous reactions nor systemic clinical signs related to the administration of the test item were observed.
- Gross pathology:
- The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes.
Any other information on results incl. tables
The LD50 of the test item is higher than 2000 mg/kg body weight by dermal route in the rat.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The LD50 of the test item : Dipropylene glycol isobornyl ether, is higher than 2000 mg/kg body weight by dermal route in the rat
- Executive summary:
The test item Dipropylenglykolisobornylether (isomerengemisch) was applied onto the intact skin of 10 Sprague Dawley rats (5 males and 5 females) at the single dose of 2.000 mg/kg bw.
The experimental protocol wasestablished on the basis of the official method as defined in the OECD guideline 402 (february 1987) and EEC B.3(92/69/EEC).
No mortality occured during the study. Macroscopic examinations of the animals at the end of the study did not reveal treatment-related changes.
The LD50 was determined to be higher than 2000 mg/kg body weight by dermal route in the rat.
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