7-methyl-3-methyleneocta-1,6-diene

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1990

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

Bodyweights not recorded

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1990

Materials and methods

Principles of method if other than guideline:

Method: Approximate lethal dose method (Deichmann WB and LeBlanc TJ, 1943)

GLP compliance:

not specified

Test type:

other: Approximate lethal dose method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

7-methyl-3-methyleneocta-1,6-diene

EC Number:

204-622-5

EC Name:

7-methyl-3-methyleneocta-1,6-diene

Cas Number:

123-35-3

Molecular formula:

C10H16

IUPAC Name:

7-methyl-3-methylideneocta-1,6-diene

Test material form:

liquid

Test animals

Species:

mouse

Strain:

Swiss

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Instituto Nacional de Controle de Qualidade em Saúde, FIOCRUZ, Rio de Janeiro, Brasil
- Age at study initiation: Three months
- Weight at study initiation: Females: 20 ± 7 g; males: 24 ± 7 g
- Fasting period before study: Overnight
- Housing: Individually in plastic cages

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-23 °C
- Photoperiod (h dark / h light): 12 h dark / 12 h artificial light

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Amount of vehicle (if gavage): 10 mL/kg
- Dose of 11390 mg/kg bw administered undiluted

Doses:

0, 1000, 1500, 2250, 3380, 5060, 7590 and 11390 mg/kg bw

No. of animals per sex per dose:

One (dose range: 0-3380 and 11390 mg/kg bw) or three (doses: 5060 and 7590 mg/kg bw)

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All signs of toxicity and deaths and their time of occurrence were recorded
- Necropsy of survivors performed: Yes
- Other examinations performed: Clinical signs and histopathology for organs showing macroscopic changes other than agonic alterations

Statistics:

No data

Results and discussion

Preliminary study:

No data

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 3 380 mg/kg bw

Based on:

test mat.

Mortality:

- At 0, 1000, 1500, 2250 and 3380 mg/kg bw: No deaths observed
- At 5060 mg/kg bw: 2/3 males and 3/3 females died within 48 hours
- At 7590 mg/kg bw: 3/3 males and 2/3 females died within 48 hours
- At 11390 mg/kg bw: 1/1 males and 1/1 females died within 48 hours

Clinical signs:

other: At 5060, 7590 and 11390 mg/kg bw: Palpebral ptosis, hypoactivity and ataxia

Gross pathology:

No effects

Other findings:

- Necropsy of animals which died prior to termination: Vacuolisation of hepatic cells and accumulation of lipids; considered to be contributory rather than the only cause of death
- Necropsy of the surviving animals: Hyperkeratosis in the non-glandular part of stomach; suggested the gastric irritant effect of myrcene

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The oral LD50 for β-myrcene is higher than 2000 mg/kg bw in mice.

Executive summary:

A study was conducted to assess the single dose toxicity of β-myrcene in Swiss albino mice using the approximate lethal dose method.

 

Groups of mice (1 or 3/sex/dose) received a single oral (gavage) dose of 0, 1000, 1500, 2250, 3380, 5060, 7590 and 11390 mg/kg bw of β-myrcene in corn oil. Parameters evaluated included survival, clinical observations and necropsy findings in all animals after a 14 day observation period.

 

Mortality was 0/1 male and 0/1 female at 0, 1000, 1500, 2250 and 3380 mg/kg bw; 2/3 males and 3/3 females at 5060 mg/kg bw; 3/3 males and 2/3 females at 7590 mg/kg bw and 1/1 male and 1/1 female at 11390 mg/kg bw. Necropsy of animals which died prior to termination revealed vacuolisation of hepatic cells and accumulation of lipids which were considered to be contributory rather than the only cause of death. Necropsy of the surviving animals revealed hyperkeratosis in the non-glandular part of stomach suggested the gastric irritant effect of myrcene. Clinical signs noted at 5060, 7590 and 11390 mg/kg bw werepalpebral ptosis, hypoactivity and ataxia.

 

In conclusion, the oral LD50 for β-myrcene is higher than 2000 mg/kg bw in mice.