Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1003.2006 to 05.05.2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD & EC 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 423 (Acute Oral toxicity - Acute Toxic Class Method)
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class 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:
female
Details on test animals or test system and environmental conditions:
obtained from: Harlan Italy S.r.l., 33049 San Pietro al Natisone (UD), Italy

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 0.5 % aqueous CMC (carboxymethyl cellulose)
Details on oral exposure:
dose volume of 10 ml/kg, using a rubber catheter attached to a syringe of suitable capacity. Animals were dosed only once.
Doses:
10 ml/kg = 2000 mg/kg
No. of animals per sex per dose:
2 groups of 3 animals
Control animals:
no
Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 30 minutes, 2 and 4 hours after dosing and daily thereafter for a total of 14 days.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology.
All animals were killed on Day 15 by carbon dioxide narcosis

Results and discussion

Preliminary study:
a group of trhee female animals was dosed at a level of 2.000 mg/kg. No mortality occured.
Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortality occurred following dosing at 2000 mg/kg in either group of female animals.
Clinical signs:
Practically no clinical symptoma within 14 days:
following dosing of the first 3 female animals at 2000 mg/kg (Step 1) the clinical signs observed on the day of dosing were limited to hunched posture and piloerection. Recovery occurred in all animals at the 4h observation.
Following dosing of the second three females at the same dose level (Step 2), clinical signs observed on the day of dosing were ataxia, hunched posture and piloerection. Recovery occurred in all females by Day 2.
Body weight:
Changes in body weight observed in the animals at the end of the observation period were within the expected range for this strain and age.
Gross pathology:
No clinical effects:
no abnormalities were observed in any animal at the necropsy examination performed at termination of the study.

Any other information on results incl. tables

LD50 was shown to be greater than 2000 mg/kg body weight.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50 was shown to be greater than 2000 mg/kg body weight.
Executive summary:

The acute toxicity of Dipropylen glycol isobornyl ether was investigated following administration of a single oral dose to the rat. No mortality or severe signs of toxicity were observed following dosing at 2000 mg/kg. These results indicate that the test item, Dipropylen glycol isobornylether, has no toxic effect in the rat following oral administration of a single dose at a level of 2000 mg/kg. The mortality pattern observed demonstrates the LD50 to be greater than 2000 mg/kg body weight.