Registration Dossier

Diss Factsheets

Administrative data

Description of key information

LD50 was considered to be > 1138 mg/kg bw when Deer mice were treated with 2-bromoethanaminium bromide orally by gavage. 

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
Data is from per- reviewed journal
Qualifier:
according to guideline
Guideline:
other: as below
Principles of method if other than guideline:
Acute oral toxicity and repellency study of 2-bromoethanaminium bromide in mice
GLP compliance:
not specified
Test type:
other: No data
Limit test:
no
Specific details on test material used for the study:
- Name of test material (as cited in study report): 2-bromoethanaminium bromide
- Molecular formula (if other than submission substance): C2H6BrN.BrH
- Molecular weight (if other than submission substance): 204.892 g/mole
- Substance type: Organic
- Physical state: Solid
Species:
mouse
Strain:
other: Deer
Sex:
not specified
Details on test animals or test system and environmental conditions:
- Weight at study initiation: 20 gms
- Diet (e.g. ad libitum): wheat seed
Route of administration:
oral: gavage
Vehicle:
other: Water , corn oil, 1% carbopol
Details on oral exposure:
2-bromoethanaminium bromide was administrated by gavage using Water , corn oil, 1% carbopol as carriers.
Doses:
1138 mg/kg bw
No. of animals per sex per dose:
2 to 4 animals were used per geometrically spaced dosage.
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 3 days
Statistics:
estimated by method of thompson and weil
Preliminary study:
No data available
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 1 138 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality observed
Mortality:
No mortality was observed in treated mice at 1138 mg/kg
Clinical signs:
No data available
Body weight:
No data available
Gross pathology:
No data available
Other findings:
No data available
Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
LD50 was considered to be > 1138 mg/kg bw when Deer mice were treated with 2-bromoethanaminium bromide orally by gavage.
Executive summary:

In a acute oral toxicity study, Deer mice were treated with 2-bromoethanaminium bromide in the concentration of 1138 mg/kg bw orally by gavage using Water , corn oil, 1% carbopol as carriers and observed for 3 days. No 50 % mortality was observed in treated mice at 1138 mg/kg bw. Therefore, LD50 was considered to be > 1138 mg/kg bw when Deer mice were treated with 2-bromoethanaminium bromide orally by gavage.  

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
1 138 mg/kg bw
Quality of whole database:
Data is Klimisch 2 and from peer- reviewed journal

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Acute oral toxicity:

In different studies, 2-bromoethanaminium bromide has been investigated for acute oral toxicity to a greater or lesser extent. Often are the studies based on in vivo experiments in rodents, i.e. most commonly in rats for 2-bromoethanaminium bromide along with the study available on structurally similar read across substance 2-(Ethylamino) ethanol (CAS no 110-73-6) and 2,2',2''-nitrilotriacetic acid (CAS no 139-13-6). The predicted data using the OECD QSAR toolbox has also been compared with the experimental studies.

In a experimental study conducted by Schaferet al(Archives of Environmental Contamination and Toxicology; 14, 111-129 (1985)), Deer mice were treated with 2-bromoethanaminium bromide in the concentration of 1138 mg/kg bw orally by gavage using Water , corn oil, 1% carbopol as carriers and observed for 3 days. No 50 % mortality was observed in treated mice at 1138 mg/kg bw. Therefore, LD50 was considered to be > 1138 mg/kg bw when Deer mice were treated with 2-bromoethanaminium bromide orally by gavage.  

In another prediction done by SSS (2017) using the OECD QSAR toolbox with log kow as the primary descriptor, the acute oral toxicity was estimated for 2-bromoethanaminium bromide. The LD50 was estimated to be 937 mg/kg bw when Swiss mice were orally exposed with 2-bromoethanaminium bromide.

Also it is further supported experimental study conducted by Cornishet al(Food Cosmetic Toxicology. Vol. 5, pp. 327-332, 1967) on structurally similar read across substance 2-(Ethylamino) ethanol (CAS no 110-73-6), Sprague-Dawley male rats were treated with 2-(Ethylamino) ethanol in the concentration of 1000 mg/kg/day orally and observed for 14 days. 50 % mortality observed in treated male at 1000 mg/kg/day. No demonstrable damage were observed in lung, liver, kidney, and spleen of treated male rats at 1000 mg/kg bw. Therefore, LD50 was considered to be 1000 mg/kg bw when Sprague-Dawley male rats were treated with 2-(Ethylamino) ethanol orally.  

This is further supported byexperimental study summarized by U.S. National Library of Medicine (ChemIDplusA TOXNET Database, 2017) on structurally similar read across substance 2,2',2''-nitrilotriacetic acid (CAS no 139-13-6), rat were treated with 2,2',2''-nitrilotriacetic acid in the concentration of1100 mg/kg/dayorally. 50 % mortality was observed in treated rat at 1100 mg/kg bw.Therefore,LD50 was considered to be1100 mg/kg bwwhenrat were treated with 2,2',2''-nitrilotriacetic acid orally.

Thus, based on the above studies and predictions on 2-bromoethanaminium bromide and its read across substances, it can be concluded that LD50 value is less than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 2-bromoethanaminium bromide can be classified as Category IV of acute oral toxicity.

Justification for classification or non-classification

Based on the above studies and predictions on 2-bromoethanaminium bromide and its read across substances, it can be concluded that LD50 value is less than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 2-bromoethanaminium bromide can be classified as Category IV of acute oral toxicity.