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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:
1988-11-28
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
3,7-dimethyloct-1-en-3-ol
EC Number:
242-358-2
EC Name:
3,7-dimethyloct-1-en-3-ol
Cas Number:
18479-49-7
Molecular formula:
C10H20O
IUPAC Name:
3,7-dimethyloct-1-en-3-ol
Test material form:
liquid

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
-Animal Breeder: DR. K. THOMAE GMBH, D-7950 BIBERACH, FRG
-Type of cage: STAINLESS STEEL WIRE MESH CAGES,TYPE DK-III ( BECKER & CO., CASTROP-RAUXEL . FRG )
-Acclimatization period: at least for 1 week
-No. of animal per cage: 5
-Animals were housed in fully air-conditioned rooms. Temperature range: 20 - 24 Celsius degrees. Relative humidity: 30 - 70%. There were no deviations from these ranges which influenced the results of the study.
-Day/Night rhythm: 12 h/12 h (6 am - 6 pm/ 6 pm - 6 am)
-Diet: Kliba-Labordiaet 343, klimgentalmuehle AG CH-4303 Kaiseraugst, Switzerland, ad libitum
Drinking water: Tap water, ad libitum
Animal weights: animal of comparable weight (+/- 20% of the mean weight)
Feed was not provided to the animals starting from 16 hours before administration but water was maintained available ad libitum.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
Reason for the vehicle: aqueous formulation corresponds to the physiological medium
Form of the administration: emulsion
Time of the day for the administration: in the morning
Doses:
Dose (mg/kg): 2000
Concentration (g/100 mL - w/v): 20
Administration volume (mL/kg): 10
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no
Details on study design:
Signs and symptons: Recording of signs and symptoms several times on the day of administration, at least once each workday, check for moribund and dead animals twice each workday and once on holidays.

Pathology: Withdrawal of food about 16 h before sacrifice with CO2, then necropsy with gross-pathological examination

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortalitiy occured.
Dead animals after 14 days: 0
Mortality: 0 %
Clinical signs:
other: other:
Gross pathology:
No pathological findings noted.
Other findings:
None

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
No animal deceased in consequence of the single treatment with the test substance at a dose level of 2000 mg/kg bw via gavage, therefore no LD50 could be determined and is therefore assumed to be >2000 mg/kg bw.
Executive summary:

For the estimate of potential acute hazard after single administration of DMOE-acetate, 5 Wistar-rats of each sex were treated by gavage with 2000 mg/kg bw/d of the test item, formulated in carboxymethyl cellulose. The treatment was followed by an observation period of 14 days and a necropsy with gross pathological examination after completion. No mortality occured during the observation period and no gross pathological findings were noted.


Due to no mortality no LD50 could be determined and was assumed to be >2000 mg/kg bw/d.