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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to OECD TG 401 and EU Method B.1 and in accordance with the Principles of GLP.
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
no
Principles of method if other than guideline:
not applicable
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Dowanol ® DPnP (Dipropylene glycol n-propylether)
- Physical state: Clear liquid
- Analytical purity: > 99%
- Lot/batch No.: MM 940619
- Stability under test conditions: Stable
- Storage condition of test material: At room temperature in the dark
- Density: 0.89 g/ml

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
Animals were obtained from Charles River, Germany. They were approximately 7 weeks old at start of treatment. Body weights of animals used in the study were within +/- 20% of the sex mean.

Animals were housed in a room maintained at 21 degrees C and a relative humidity of 50%. Fluctuations from these conditions occurred, but did not affect study integrity. The lighting cycle was 12 hours light/12 hour dark, and there were 15 air changes/hour.

Animals were housed 5/sex/cage in polycarbonate cages containing purified sawdust bedding material, and were allowed free access to standard pelleted laboratory animal diet (Carfil Quality BVBA, Oud-Turnhout, Belgium) and tap water (with the exception that food was withheld overnight prior to dosing until 3-4 hours after dosing). Animals were acclimated at least 5 days before treatment.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
Five animals/sex dosed once, on Day 1
Doses:
2000 mg/kg body weight (2.247 ml/kg)
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
Animals were observed twice daily for mortality and at periodic intervals on Day 1 and once daily thereafter for clinical signs. All animals surviving to the end of the 15 day observation period were euthanized and subjected to a gross necropsy.
Statistics:
No statistical analyses was perrformed

Results and discussion

Preliminary study:
not applicable
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
One male died within 1 hour of treatment.
Clinical signs:
Lethargy, uncoordinated movements and/or hunched posture in all animals until Day 2. These symptoms had disappeared in all surviving by day 2. Chromodacryorrhea was observed in one male from Day 1 to Day 6.
Body weight:
Body weight gain over the study period was considered to be normal
Gross pathology:
No abnormalities
Other findings:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The oral LD50 value of Dowanol ® DPnP (Dipropylene glycol n-propylether) in rats (both sexes) was established as greater than 2000 mg/kg bw. and hence based on the Guidance to Regulation (EC) No. 1272/2008 on Classification, Labelling and Packaging of substances and mixtures, Dowanol ® DPnP (Dipropylene glycol n-propylether) will not be classified.
Executive summary:

This study was carried out in accordance with OECD Guideline No. 401, "Acute Oral Toxicity" and EEC Directive 92/69/EEC, Part B.1, "Acute Toxicity-Oral” to evaluate the acute oral toxicity potential of Dowanol ® DPnP (Dipropylene glycol n-propylether).

Dowanol ® DPnP (Dipropylene glycol n-propylether) was administered by oral gavage to five rats of each sex per group, at 2000 mg/kg body weight. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed on the day of death or at the end o f the experimental period (day 15). One male died on day 1. Lethargy, uncoordinated movements and/or hunched posture were observed in the animals on day 1.Chromodacryorrhoea was observed in one male from day 1 until day 6. Body weight gain shown by the animals over the study period was considered to be normal. No abnormalities were found in the animals at macroscopic post mortem examination.

The oral LD50 value of Dowanol ® DPnP (Dipropylene glycol n-propylether) in rats was established as exceeding 2000 mg/kg body weight and hence based on the Guidance to Regulation (EC) No. 1272/2008 on Classification, Labelling and Packaging of substances and mixtures, Dowanol ® DPnP (Dipropylene glycol n-propylether) will not be classified.