Isooctyldinitrophenol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

27 July 1982 to 10 August 1982

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study conducted to sound scientific principles.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Isooctyldinitrophenol

EC Number:

253-410-9

EC Name:

Isooctyldinitrophenol

Cas Number:

37224-61-6

Molecular formula:

C14H20N2O5

IUPAC Name:

4-(6-methylheptyl)-3,5-dinitrophenol

Test animals

Species:

mouse

Strain:

CD-1

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Fasting period before study: yes, the animals were fasted for approximately 4 hours.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Doses:

0, 60, 75, 95, 119, 150 mg/kg

No. of animals per sex per dose:

10 males per dose

Control animals:

yes

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

122 mg/kg bw

Based on:

test mat.

95% CL:

104 - 166

Any other information on results incl. tables

Mortality

None of the mice in the vehicle control group died during the study; in groups dosed with test material at 60, 75, 95, 119, and 150 mg/kg 0, 1, 3, 3, and 8 mice died, respectively.

Table 1: Clinical Signs

Signs	Dosage level (mg/kg)
	150	119	95	75	60	0
Passiveness	6/10	4/10	1/10	1/9	1/10
Brown-stained anogenital area		1/10
Diarrhea	1/10
Scant droppings	3/3	8/8	8/8	9/9
Moribund	1/7	1/9	1/10
Ataxia	1/7	3/9	2/10	1/9
Prostration			1/8
Abdominal breathing	7/10	6/10	4/10	2/9
Wet fur			1/8
Tremors	1/4	2/9	1/10
Wet yellow stained anogenital area	5/7	9/9	10/10	9/9	10/10	8/10
Decreased spontaneous motor activity	6/7	6/10	8/10	4/9	7/10

Body Weight Gain

Group mean body weights increased for each dose group.

Necropsy

Observations at necropsy in the decedents included the following;

- Severe autolysis in 2 /8 mice in the 150 mg/kg dose group and 1/3 mice in the 119 and 95 mg/kg dose group.

- Wet yellow attained anogenital area was observed in 6/8 mice in the 150 mg/kg dose group, and 2/3 mice in the 119 and 95 mg/kg dose groups.

No gross changes were recorded at necropsy in the survivors.

Applicant's summary and conclusion

Interpretation of results:

other: Category 3 (CLP)

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of the study the acute oral LD50 was determined to be 122 mg/kg to male CD-1 mice.

Executive summary:

The acute oral toxicity of the test material was investigated in a study in which groups of 10 male CD-1 mice were administered a suspension of test material in corn oil at 0 (vehicle control), 60, 75, 95, 119, or 150 mg/kg bw, orally, via gavage. The mice were observed over a period of 14 days for mortality and clinical signs; body weights were recorded at study initiation and again at termination (group average). All animals were subjected to gross necropsy at termination.

Under the conditions of the study, the acute oral LD50 was determined to be 122 mg/kg to male CD-1 mice.