Registration Dossier

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:
2006
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

Constituent 1
Chemical structure
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)

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.