Acetic acid, esters with turpentine-oil myrcene fraction terpene alcs.

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

March 1969

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study meets the EC Standards (conducted equivalent to OECD 401), although prior to GLP principles. Well described report.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1969

Report date:

1969

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Remarks:

not present at the time of performance.

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

p-menth-1-en-8-yl acetate

EC Number:

201-265-7

EC Name:

p-menth-1-en-8-yl acetate

Cas Number:

80-26-2

Molecular formula:

C12H20O2

IUPAC Name:

1-methyl-1-(4-methylcyclohex-3-en-1-yl)ethyl acetate

Constituent 2

Reference substance name:

Myrcenyl acetate

EC Number:

214-262-0

EC Name:

Myrcenyl acetate

Cas Number:

1118-39-4

Molecular formula:

C12H20O2

IUPAC Name:

1,1-dimethyl-5-methylenehept-6-en-1-yl acetate

Constituent 3

Reference substance name:

(E)-2-(3,3-dimethylcyclohexylidene)ethyl acetate

EC Number:

308-183-1

EC Name:

(E)-2-(3,3-dimethylcyclohexylidene)ethyl acetate

Cas Number:

97890-04-5

Molecular formula:

C12H20O2

IUPAC Name:

(E)-2-(3,3-dimethylcyclohexylidene)ethyl acetate

Constituent 4

Reference substance name:

(Z)-2-(3,3-dimethylcyclohexylidene)ethyl acetate

EC Number:

308-184-7

EC Name:

(Z)-2-(3,3-dimethylcyclohexylidene)ethyl acetate

Cas Number:

97890-05-6

Molecular formula:

C12H20O2

IUPAC Name:

(Z)-2-(3,3-dimethylcyclohexylidene)ethyl acetate

Constituent 5

Reference substance name:

Geranyl acetate

EC Number:

203-341-5

EC Name:

Geranyl acetate

Cas Number:

105-87-3

Molecular formula:

C12H20O2

IUPAC Name:

(E)-3,7-dimethylocta-2,6-dien-1-yl acetate

Constituent 6

Reference substance name:

1-methyl-4-(1-methylethylidene)cyclohexyl acetate

EC Number:

233-564-3

EC Name:

1-methyl-4-(1-methylethylidene)cyclohexyl acetate

Cas Number:

10235-63-9

Molecular formula:

C12H20O2

IUPAC Name:

4-isopropylidene-1-methylcyclohexyl acetate

Constituent 7

Reference substance name:

4-(5-methyl-1-methylene-4-hexenyl)-1-(4-methylpent-3-enyl)cyclohexene

EC Number:

208-546-3

EC Name:

4-(5-methyl-1-methylene-4-hexenyl)-1-(4-methylpent-3-enyl)cyclohexene

Cas Number:

532-87-6

Molecular formula:

C20H32

IUPAC Name:

4-(5-methyl-1-methylenehex-4-en-1-yl)-1-(4-methylpent-3-en-1-yl)cyclohexene

Constituent 8

Reference substance name:

cis-1-methyl-4-(1-methylvinyl)cyclohexyl acetate

EC Number:

244-028-3

EC Name:

cis-1-methyl-4-(1-methylvinyl)cyclohexyl acetate

Cas Number:

20777-47-3

Molecular formula:

C12H20O2

IUPAC Name:

4-isopropenyl-1-methylcyclohexyl acetate

Constituent 9

Reference substance name:

p-menth-1-en-8-ol

EC Number:

202-680-6

EC Name:

p-menth-1-en-8-ol

Cas Number:

98-55-5

Molecular formula:

C10H16O

IUPAC Name:

2-(4-methylcyclohex-3-en-1-yl)propan-2-ol

Constituent 10

Reference substance name:

Neryl acetate

EC Number:

205-459-2

EC Name:

Neryl acetate

Cas Number:

141-12-8

Molecular formula:

C12H20O2

IUPAC Name:

(Z)-3,7-dimethylocta-2,6-dien-1-yl acetate

Constituent 11

Reference substance name:

1-(3,3-dimethylcyclohex-1-en-1-yl)ethyl acetate

Cas Number:

150461-96-4

Molecular formula:

C12H20O2

IUPAC Name:

1-(3,3-dimethylcyclohex-1-en-1-yl)ethyl acetate

Constituent 12

Reference substance name:

Tentative monoterpene diacetate

IUPAC Name:

Tentative monoterpene diacetate

Constituent 13

Reference substance name:

Tentative oxygenated monoterpene acetate

IUPAC Name:

Tentative oxygenated monoterpene acetate

Constituent 14

Reference substance name:

Tentative Diterpene hydrocarbon

IUPAC Name:

Tentative Diterpene hydrocarbon

Constituent 15

Reference substance name:

Unresolved/non-elucidated mixed terpene/diterpene/oxygenated terpene/terpene acetate derivatives

IUPAC Name:

Unresolved/non-elucidated mixed terpene/diterpene/oxygenated terpene/terpene acetate derivatives

Test material form:

liquid

Specific details on test material used for the study:

Neobergamate N, F-2558, Aan. 48898

Test animals

Species:

rat

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: young adults
- Weight at study initiation: males: 150-250 g; females: 100 - 200 g
- Fasting period before study: 16 hours
- Housing: housed in groups of five animals
- Diet: ad libitum, after treatment (no further details available)
- Water: tap water, ad libitum, after treatment

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

9, 10 and 11 mL/kg bw

No. of animals per sex per dose:

5

Control animals:

other: not required

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

10.8 mL/kg bw

Based on:

test mat.

95% CL:

10 - 11.6

Mortality:

See the section "Any other information on results incl. tables". The animals died 2 to 3 days after treatment.

Clinical signs:

other: Until 4 hours after treatment the animals did not show any visible reactions. After 4 to 6 hours all rats became sluggish. Three days after treatment the surviving animals looked quite healthy again.

Gross pathology:

The survivors did not show any macroscopical changes.

Any other information on results incl. tables

Dose [mL/kg bw]	Mortality
	Number		Percentage
	Males	Females
9	1	0	10
10	1	1	20
11	2	4	60

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In an acute oral toxicity with rats, an LD50 of 10.8 mL/kg bw was determined.

Executive summary:

The substance was tested in an acute oral toxicity study with male and female rats at 9, 10 and 11 mL/kg bw. Two to three days after treatment, animals died in all dose groups. Based on the results of this study, the LD50 was determined to be 10.8 mL/kg bw.