Ethanol, 2,2'-iminobis-, N-(C13-15-branched and linear alkyl) derivs.

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:

other: Comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

According to "Standard Operating Procedure No CT20-090/01" as cited in text, number of animals, analytical purity of test substance and experimental conditions not specified

GLP compliance:

no

Test type:

standard acute method

Test material

Test material information

Constituent 1

Reference substance name:

Ethanol, 2,2'-iminobis-, N-(C13-15-branched and linear alkyl) derivs.

EC Number:

308-208-6

EC Name:

Ethanol, 2,2'-iminobis-, N-(C13-15-branched and linear alkyl) derivs.

Cas Number:

97925-95-6

Molecular formula:

Not applicable - multiconstituent substance

IUPAC Name:

Ethanol, 2,2'-iminobis-, N-(C13-15-branched and linear alkyl) derivs.

Test animals

Species:

rat

Strain:

other: Alderley Park, SPF-derived, albino strain

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: Young adult, not further specified

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: Material used as a 20% (w/v) emulsion in corn oil for a dose of 2000 mg/kg bw and as a 15%, 13.5%, 12.5% 10% and 5% (w/v) emulsion in corn oil for doses of 1500, 1350, 1250, 1000 and 500 mg/kg bw respectively.

Doses:

500, 1000, 1250, 1350, 1500 and 2000 mg/kg bw

No. of animals per sex per dose:

No data, but results of mortalities indicate that ≥5

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: Up to 8 days reported
- Other examinations performed: clinical signs

Statistics:

The LD50 was calculated by the logit method (Berkson, 1944)

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

1 500 mg/kg bw

Based on:

test mat.

95% CL:

1 100 - 2 000

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

1 300 mg/kg bw

Based on:

test mat.

95% CL:

1 250 - 2 000

Mortality:

2000 mg/kg bw: 4 male and 5 female dead by day 6
1500 mg/kg bw: 2 male and 4 female dead by day 8
1350 mg/kg bw: Only females treated, all dead by day 4
1250 mg/kg bw: Only females treated, no deaths
1000 mg/kg bw: 1 male dead by day 4
500 mg/kg bw: No deaths

Clinical signs:

other: 2000 mg/kg bw: Subdued appearance, piloerection, chromodacryorrhoea, scouring, curvature of spine, laboured respiration and a red stain around the snout 1500 mg/kg bw: Slight piloerection, incontinence, salivation and an ungroomed appearance 1350, 1250, 1

Gross pathology:

No data

Any other information on results incl. tables

Clinical signs observed in this study are reported to be indicative of excessive para-sympathetic nervous activity. Atmer 163 with a LD50 of 1500 mg/kg bw in male and 1300 mg/kg bw in female rats by oral route has to be classified:

CLP: Category 4, H302 (harmful if swallowed)

DSD: Xn, R22 (harmful)

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria