Myrcenyl acetate

Endpoint summary

Description of key information

Acute oral toxicity: similar to OECD TG 401: 6300 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:

1972

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)

Deviations:

no

GLP compliance:

no

Remarks:

Test was done before GLP came into force.

Test type:

standard acute method

Limit test:

no

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 200 - 250 gram
- Fasting period before study: a minimum of 16 hours prior to administration of the test material
- Diet: ad libitum
- Water: ad libitum

Route of administration:

oral: unspecified

Details on oral exposure:

Test substance was administered as a concentrate.

Doses:

4000, 5000, 6250 and 7800 mg/kg bw

No. of animals per sex per dose:

10 per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days.
- Frequency of observations: Observations for mortality were made at 1 and 6 hours after application and thereafter daily.
- Necropsy of survivors performed: Gross necropsies were performed on all survivors.

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

6 300 mg/kg bw

Based on:

test mat.

95% CL:

>= 5 300 - <= 7 300

Mortality:

Dose: Deaths
4000 mg/kg bw: 1/10
5000 mg/kg bw: 3/10
6250 mg/kg bw: 5/10
7800 mg/kg bw: 7/10
Deaths occurred overnight to three days following administration of the drug.

Clinical signs:

The rats experienced piloerection and lethargy.

Interpretation of results:

other: not classified

Remarks:

criteria not met according to EU CLP 1272/2008 and its amendments.

Conclusions:

The acute oral toxicity test showed a calculated LD50 of 6300 mg/kg bw. The substance does not need to be classified for acute oral toxicity according to GHS.

Executive summary:

Acute oral toxicity: In this study, 40 male rats (10/dose) were administered the substance at dose levels of 4000, 5000, 6250, 7800 mg/kg bw. The test material was administered as a concentrate. At dosage 4000 mg/kg bw 1/10 animals died, at 5000 mg/kg bw 3/10 animals died, at 6250 mg/kg bw 5/10 animals died and at 7800 mg/kg bw 7/10 animals died. The rats experienced piloerection and lethargy. Deaths occurred overnight to three days following administration of the substance. The calculated acute oral LD50 is 6300 mg/kg bw, the 95% confidence limit is 5300-7300 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Additional information

Acute oral toxicity: In this study, 40 male rats (10/dose) were administered the substance at dose levels of 4000, 5000, 6250, 7800 mg/kg bw. The test material was administered as a concentrate. At dosage 4000 mg/kg bw 1/10 animals died, at 5000 mg/kg bw 3/10 animals died, at 6250 mg/kg bw 5/10 animals died and at 7800 mg/kg bw 7/10 animals died. The rats experienced piloerection and lethargy. Deaths occurred overnight to three days following administration of the substance. The calculated acute oral LD50 is 6300 mg/kg bw, the 95% confidence limit is 5300-7300 mg/kg bw.

A dermal acute toxicity study is also available which showed a LD50 value of >5000 mg/kg bw. The result of this study does not impact the classification for acute dermal toxicity.

Justification for classification or non-classification

According to the criteria outlined in Annex I of 1272/2008/EC (CLP) and its amendments, the substance does not have to be classified as acute toxic by the oral route.