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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:
1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented study report which meets basic scientific principles

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
Method: BASF-Test
TEST PROCEDURE
In principle, the methods described in OECD Guideline 401 were used.
Young adult laboratory rats were purchased from a breeder. Several groups of 5 to 10 rats per sex and dose were treated simultaneously by gavage with preparations of the test substance in a suitable vehicle. The concentrations of these preparations were usually adjusted to achieve comparable volumes (e.g. 10 ml) per kg body weight.
Group-wise documentation of clinical signs was performed over the 7- to 14 -day study period. Body weight was determined before the start of the study only, as it was needed for determination of dose.
The clinical signs and findings were reported in summary form.
On the basis of the observed lethality, the LD50 value was estimated or determined using a graphical evaluation of the dose response curve on probability paper.
GLP compliance:
no
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): Methoxypropoxypropanol
- Physical state: liquid
- Substance number: 78/187

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Mean weight at study initiation: 220 g (male) and 170 g (female)
- Fasting period before study: 15-20 hours before application

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 50%

MAXIMUM DOSE VOLUME APPLIED
- Dose: 5000 mg/kg bw
- Applied volume: 10 ml/kg bw
Doses:
5000 mg/kg
No. of animals per sex per dose:
5 male and 4 female
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: days 1, 2, 3, 7 and 13
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
0%
(no animal died after application of the TS and during the observation period)
Clinical signs:
dyspnea, apathy, abnormal position, stagger, atony, loss of pain reflex, narcosis-like state, spastic gait, scrubby fur, exsiccosis, salivation, poor general condition
Body weight:
see table in the "remarks on results"-field
Gross pathology:
organs were without findings

Any other information on results incl. tables

 Number of animals     Male   Female
5 4
 dead animals after: 1 hour 0
 1 day 0
 2 days 0
 7 days 0
 14 days 0

 Mean weight (g)   Male    Female
 before application of TS  220  170
 after 2 -4 days  226  177
 after 7 days  266  199
 after 14 days (male) after 13 days (female)  304  213

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Dipropylene glycol methyl ether is not acutely toxic via the oral route. Based on the oral LD50 > 5000 mg/kg no classification is required according to EU criteria.