3,7-dimethyloct-1-en-3-yl acetate

Endpoint summary

Description of key information

Acute oral toxicity:

No animal deceased in consequence of the single treatment with DMOE, a hydrolysis product of DMOE-Acetate, at a dose level of 2000 mg/kg bw via gavage, so that no LD50 could be determined and is therefore assumed to be >2000 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

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.

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

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

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

> 2 500 mg/kg bw

Quality of whole database:

Reliable with restrictions

Additional information

Acute oral toxicity:

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 findins were noted.

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

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

Experimental acute toxicity data is available on a hydrolysis product of DMOE-Acetate, DMOE, and is used for read across. Study results showed no mortality at a dose level of 2000 mg/kg bw/d. This results in no classification according to Regulation (EC) No 1272/2008, as amended for the seventeenth time in Regulation (EU) 2021/849.