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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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

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 levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
1 500 mg/kg bw
Based on:
test mat.
95% CL:
1 100 - 2 000
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