Registration Dossier

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:
2007
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

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:
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:
Neither cutaneous reactions nor systemic clinical signs related to the administration of the test item were observed.
Body weight:
The body weight evolution of the animals remained normal throughout the study, similar between treated and control animals.
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.