Octanal, 7-hydroxy-3,7-dimethyl-, reaction products with 1H-indole

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Principles of method if other than guideline:

Method provided in 'Details on Oral Exposure'
LD50 was calculated according to the method of Litchfield, J.T. Jr., & F. Wilcoxon JPET 96:99, 1949.

GLP compliance:

no

Remarks:

study pre-dates introduction of GLP

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

η-1H-indol-3-yl-α,α,ε-trimethyl-1H-indole-3-heptanol

EC Number:

267-434-2

EC Name:

η-1H-indol-3-yl-α,α,ε-trimethyl-1H-indole-3-heptanol

Cas Number:

67860-00-8

Molecular formula:

C26H32N2O

IUPAC Name:

8,8-di(1H-indol-3-yl)-2,6-dimethyloctan-2-ol

Constituent 2

Reference substance name:

Indole

EC Number:

204-420-7

EC Name:

Indole

Cas Number:

120-72-9

Molecular formula:

C8H7N

IUPAC Name:

1H-indole

Constituent 3

Reference substance name:

7-hydroxycitronellal

EC Number:

203-518-7

EC Name:

7-hydroxycitronellal

Cas Number:

107-75-5

Molecular formula:

C10H20O2

IUPAC Name:

7-hydroxy-3,7-dimethyloctanal

Constituent 4

Reference substance name:

1-(1H-indol-1-yl)-3,7-dimethyloctane-1,7-diol

Cas Number:

1642782-49-7

Molecular formula:

C18H27NO2

IUPAC Name:

1-(1H-indol-1-yl)-3,7-dimethyloctane-1,7-diol

Constituent 5

Reference substance name:

Unknown constituents

IUPAC Name:

Unknown constituents

Specific details on test material used for the study:

Sample Label: 79-44, Indolene, Lot # 14
Sample received: 12/27/79

Test animals

Species:

mouse

Strain:

Swiss Webster

Sex:

male

Details on test animals or test system and environmental conditions:

Swiss Webster mice, approximately 8 weeks old, when received were equilibrated for at least one week in the laboratory. Apparently healthy mice were selected for the test.
The animals were identified by cage tags noting the test material, starting date, animal number and sex.
The animals were housed 5 / cage in suspended wire mesh cages (20'' x 10'' x 7''). Fresh Purina mouse chow and water were freely available except for 16-20 hours prior to dosing when the food was removed. The animal room, reserved exclusively for rodents on acute tests, was maintained at 20 - 21 °C and was kept clean in accordance with the standards of AAALAC of which the laboratory is an approved member.
Supplied: Ace Animals
Weight range: 14 - 16 g
Sex: 10 males

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

not specified

Details on oral exposure:

The test material was given orally by syringe and 18 gauge blunt end needle. One group of 10 male mice was dosed at 5.0 g/kg of body weight. For liquid materials, the dose was based on the sample weight as calculated from the specific gravity. The vehicle, if any, was chosen becuase of its lack of known toxicity, lack of physiological effect and because it is relatively unreactive with other chemical substances.

Doses:

5000 mg/kg

No. of animals per sex per dose:

10 males

Control animals:

no

Details on study design:

Observations: The mice were observed 3-4 hours after dosing and once daily for 14 days. Mortality, toxicity and pharmacological effects were recorded.
Termination: At 14 days the survivors were sacrificed. All animals were examined for gross pathology.
The LD50 was calculated according to the method of Litchfield, J.T. Jr., & F. Wilcoxon JPET 96:99, 1949.

Results and discussion

Effect levels

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

4/10. Four animals died at this dose level. Two animals died 3-4 hours post dose, one animal on Day 1 and one animal Day 2.

Clinical signs:

other: Five or more animals showed signs of lethargy, ptosis and piloerection 3-4 hours post dose. Signs of tremors, ptosis and lethargy were noted during the study. Three animals were normal on Day 14.

Gross pathology:

Six animals, sacrificed of Day 14, were normal and showed no gross pathologies. Animals which died showed signs of brown stain at nose /mouth area; slightly or moderatley congested lungs; slightly hemorrhagic lungs; slightly dilated heart; stomachs slightly red; intestines slightly red; and intestines moderatley distended by mucus.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test material is not toxic, as defined in 16 CFR 1500.3, at a dose level of 5.0 g/kg of body weight.

Executive summary:

Four out of ten male mice died at a dose of 5000 mg/kg Indolene. The most common signs of toxicity were lethargy, ptosis and piloerection. Internal organs of all surviving animals showed no gross pathology. Animals that died prior to Day 14 had respiratory, cardiac and gastrointestinal abnormalities.