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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:
weight of evidence
Study period:
1995
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study performed under GLP. All relevant validity criteria are met.
Cross-reference
Reason / purpose:
read-across: supporting information

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:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Deviations:
no
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
Qualifier:
equivalent or similar to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): dipropylene glycol
- Physical state: clear viscous liquid
- Storage condition of test material: in the original container at room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Recognised supplier
- Age at study initiation: males, 8 weeks of age; females, 10 weeks of age
- Weight at study initiation: males, 254 to 259 grams; females, 201 to 216 grams
- Fasting period before study: 18 hours, water was available at all times
- Housing: individually housed in wire cages under laboratory conditions.
- Diet (e.g. ad libitum): NIH-31M rodent diet, ad libitum
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-23
- Humidity (%): 35-65
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12 hour dark / 12 hours light

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
5010 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: First 5 hours post dose and then from 24 hours at twice daily intervals for 14 days
- Frequency of observations and weighing: All animals were examined shortly before and after dosing. On the day of dosing all animals were weighed and on day 15.
- Necropsy of survivors performed: Yes. Any animal found dead during the study would have undergone necropsy immediately.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality.
Clinical signs:
At one hour after dosing two males showed decreased locomotor activity and the remaninder of the group (3 male, 5 female) were ataxic. Similar signs persisted at three hours. At five hours following dosing several rats (4 male, 1 female) also showed yellow perineal staining, By Day 1 all rats appeared normal and remained so through the duration of the study. All animals recovered within 24 hours.
Body weight:
There was no significant impact on body weight. All animals gained body weight.
Gross pathology:
No significant findings.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study, the LD50 (male/female) was determined to be > 5000 mg/kg bw
Executive summary:

The study was performed according to EPA OPPTS 870.1100 (Acute Oral Toxicity) in accordance with GLP to assess the acute oral toxicity potential of the test substance to Sprague Dawley male/female rats. Following an acclimatisation period and overnight fasting, the test material was administered as a single oral dose to a group of five male and five female rats by oral gavage at a dose level of 5000 mg/kg bodyweight. All animals were observed for a fourteen day period for any signs of toxicity or other effects of treatment, after which they were subjected to gross necropsy. There was no significant effects observed during the study. All animals gained body weight. No abnormalities were observed during gross necropsy. Applicant assessment indicates that under the conditions of this study the LD50 male/female rats should be considered to be > 5000 mg/kg bw.