Registration Dossier
Registration Dossier
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EC number: 470-680-5 | CAS number: 958872-63-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 10.03.2006 to 13.05.2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD & EEC guideline study no deviations GLP
Cross-reference
- 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 guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
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:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Female rabbits, strain: New Zealand White / Specific Pathogen Free (SPF) strain were supplied by Charles River Laboratories Site ESD-Romans-01400 Châtillon sur Chalaronne, France
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: undiluted
- Controls:
- not required
- Amount / concentration applied:
-
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): An 0.5 ml aliquot (500 mg)
- Concentration (if solution):undiluted
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
- Number of animals:
- 3
- Details on study design:
- An 0.5 ml aliquot (500 mg) of the supplied undiluted test item was spread evenly over a square gauze measuring 2.5x2.5 cm. The square gauze was then placed onto the animal’s skin with the test item in direct contact with the skin
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- no.297
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: mean of all observations
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- no.315
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: mean of all observations
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- no.317
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: mean of all observations
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- no.297
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: mean of all observations
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- no.315
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: mean of all observations
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- no.317
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: mean of all observations
- Irritant / corrosive response data:
- No corrosion or irritation were apparent (all scores 0) following a 4 hours period of exposure to the test item.
- Other effects:
- none
Any other information on results incl. tables
No corrosion or irritation were apparent (all scores 0) following a 4 hours period of exposure to the test item.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- No corrosion or irritation were observed at the treated site following a 4 hour exposure period (all scores 0). These results indicate that based upon classification criteria of European Directives concerning the classification, packaging and labelling of dangerous substances (67/548/EEC and subsequent revisions) Dipropylen glycol isoborny lether (mixture of isomers) is not irritating to rabbit skin.
- Executive summary:
The acute dermal irritation of Dipropylenglykolisobornylether (isomerengemisch) was investigated in rabbits, in accordance with OECD guideline 404 and EEC guideline B.4.
An 0.5 ml aliquot of the test substance was applied to the prepared dorsal skin of 3 animals for 4 hours. The resulting reaction to the treatment was assessed 1, 24, 48 and 72 hours after the end of the exposure.
No corrosion or irritation were observed at the treated site following a 4 hour exposure period (all scores 0). These results indicate that based upon classification criteria of European Directives concerning the classification, packaging and labelling of dangerous substances (67/548/EEC and subsequent revisions) Dipropylen glycol isoborny lether (mixture of isomers) is not irritating to rabbit skin.
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