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Diss Factsheets

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:
19 Feb 1974 - 01 Mar 1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable study report which meets basic scientific principles

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report date:
1975

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
Principles of method if other than guideline:
Method: BASF-Test which follows in principle the methods described in OECD Guideline 401.
5 rats per sex and dose were treated simultaneously by gavage with preparations of the test substance in water. Group-wise documentation of clinical signs was performed over the 7 day study period. The clinical signs and findings were reported in summary form.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2-(2-(2-methoxyethoxy)ethoxy)ethanol
EC Number:
203-962-1
EC Name:
2-(2-(2-methoxyethoxy)ethoxy)ethanol
Cas Number:
112-35-6
Molecular formula:
C7H16O4
IUPAC Name:
2-[2-(2-methoxyethoxy)ethoxy]ethan-1-ol
Details on test material:
- Name of test material (as cited in study report): Methyltriglykol. Test substance No. 88/289
- Physical state: liquid
- Analytical purity: ca. 95%

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: male: 186g (mean), female 165g (mean)

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 35% for 10500 mg/kg and 15% for 1050 and 2257 mg/kg
Doses:
1050, 2257, 10500 mg/kg bw
No. of animals per sex per dose:
5 male and 5 female rats per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Necropsy of survivors performed: yes
Statistics:
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.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 10 500 mg/kg bw
Mortality:
no mortality occured.
Clinical signs:
other: Signs of toxicity comprised at 10500 mg/kg: apathy, spastic gait, dyspnea, mouth and eyelid crust formation.
Gross pathology:
At necroscopy no abnormalities were observed.

Any other information on results incl. tables

Mean Body weights (g) MALES:

Dose group (mg/kg)

Day 0

Day 3

Day 7

1050

190

210

205

2257

199

228

222

10500

169

124

159

 

Mean Body weights (g) FEMALES:

Dose group (mg/kg)

Day 0

Day 3

Day 7

1050

165

184

167

2257

163

178

170

10500

168

192

178

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Executive summary:

In an acute oral toxicity study that followed the basic requirements of the OECD standard protocol guideline, male and female rats were exposed to single gavage doses of 2 -(2 -(2 -methoxyethoxy)ethoxy)ethanol at doses up to 10500mg/kg. The high dose animals showed apathy, spastic gait, dyspnea, mouth and eyelid crust formation and males also showed a sharp but transient drop in body. However, no mortality was reported implying that the LD50 is significantly in excess of the maximum dose tested.

Synopsis

LD50 (male, female) >10500mg/kg