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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: Acceptable, well-documented publication that meets basic scientific principles

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report date:
1984

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Reference substance name:
(2-carboxyethyl)({2-[(2-carboxyethyl)(2-hydroxyethyl)amino]ethyl})azanium; [({2-[(2-carboxyethyl)(2-hydroxyethyl)amino]ethyl}carbamoyl)methyl](dodecyl)dimethylazanium; ethanol
IUPAC Name:
(2-carboxyethyl)({2-[(2-carboxyethyl)(2-hydroxyethyl)amino]ethyl})azanium; [({2-[(2-carboxyethyl)(2-hydroxyethyl)amino]ethyl}carbamoyl)methyl](dodecyl)dimethylazanium; ethanol

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga, Sulzfeld
- Age at study initiation: 4 - 7 weeks old
- Weight at study initiation: male 100 - 125 g, female 90 - 115 g
- Fasting period before study: overnight
- Housing: single
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 23°C
- Humidity (%): 40 - 70 %
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 hours / 12 hours

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw


Doses:
4 dose levels: 4000, 5040, 6350 and 8002 mg/kg bw
No. of animals per sex per dose:
5 male and 5 female per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations: 15 min, 30 min, 1 hour, 2 hours, 4 hours on day of application, once per day thereafter
weighing on day -1, 0, 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: no

Results and discussion

Preliminary study:
Range finding study with 3 doses: 1000, 2500, 5000 mg/kg bw,
Result: 50 % mortality at 5000 mg/kg
Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
5 106 mg/kg bw
Based on:
test mat.
95% CL:
4 306 - 5 822
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 553 mg/kg bw
Based on:
act. ingr.
Mortality:
Dose 4000 mg/kg bw: mortality 2/10
Dose 5040 mg/kg bw: mortality 5/10
Dose 6350 mg/kg bw. mortality 7/10
Dose 8002 mg/kg bw: mortality 10/10
Clinical signs:
other: rough fur, eyes closed, sedation, diarrhoea, ataxia, ventral position, gasping, respiration increased, exophthalmos
Gross pathology:
The necropsy 14 days after application showed no substance related morphological visible pathologic organ findings in the survived animals.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
LD50 > 2000 mg/kg, the test item is not acute toxic following single oral application.
Executive summary:

In an acute oral toxicity study similar to OECD guideline 401, each 5 male/ 5 female, fasted, 4 -7 weeks old Sprague-Dawley rats were given a single oral dose of the test substance by gavage at doses of 4000, 5040, 6350 and 8002 mg/kg bw and observed for 14 days. Clinical signs and death was observed in all dose groups; mortality was 2/10, 5/10, 7/10 and 10/10 in the doses 4000, 5040, 6350 and 8002 mg/kg bw, respectively. The LD50 was calculated to be 5106 mg/kg bw for the test item and 2553 mg/kg bw for the active ingredient. All surviving animals gained the expected weight at the end of the study period. No pathological changes were observed in these animals at necropsy.

 

Oral LD50 (rat) > 2000  mg/kg bw