Ammonium bromide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1986-06-11 to 1986-07-10

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1997

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPP 81-1 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Ammonium bromide

EC Number:

235-183-8

EC Name:

Ammonium bromide

Cas Number:

12124-97-9

Molecular formula:

BrH4N

IUPAC Name:

Bromide activated chloramine (BAC) generated from ammonium bromide and sodium hypochlorite

Details on test material:

- Name of test material (as cited in study report): NH4Br (Ammonium Bromide)
- Description: White crystalline powder
- Analytical purity: n.a.
- Lot/batch No.: LSRI No: 091358186, Batch No: 5230

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, U. K.
- Age at study initiation: 5 weeks
- Weight at study initiation: males 112-143 g and females 110-129 g
- Fasting period before study: 18 hours
- Housing: Type RCI cages of high density polypropylene body, measuring 56 x 38 x 18 cm with stainless steel grid floors and tops.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 25°C
- Humidity (%): 40% - 70%
- Air changes (per hr): 17
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle

IN-LIFE DATES: From: 1986-06-11 To: 1986-07-10

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: The test material was prepared at appropriate concentrations in distilled water to permit administration at a constant volume-dosage of 20 ml/kg bodyweight.
- Amount of vehicle (if gavage): 20 ml/kg bw


MAXIMUM DOSE VOLUME APPLIED: 20 ml/kg bw

Doses:

2000, 2714, 3684 and 5000 mg/kg bw

No. of animals per sex per dose:

5/sex/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Post-treatment observations at least twice daily during the first 7 days after dosage and daily observations until day 15;
body weight was taken the day before and the day of dosage and then once per week;
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

2 868 mg/kg bw

Based on:

test mat.

95% CL:

2 266 - 3 471

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

2 566 mg/kg bw

Based on:

test mat.

95% CL:

2 062 - 3 071

Effect levels 3

Sex:

male/female

Dose descriptor:

LD50

Effect level:

2 714 mg/kg bw

Based on:

test mat.

95% CL:

2 540 - 2 888

Mortality:

There were no deaths among rats treated at 2000 mg/kg ammonium bromide. One male and four female rats treated at 2714 mg/kg died within one hour after dosing. All animals receiving 3684 mg/kg and 5000 mg/kg died between 30 minutes and one day after dosing.

Clinical signs:

other: The most frequent observations were lethargy, decreased motor activity, prone or hunched posture, ataxia and breathing irregularities. Unconsciousness and tonic convulsions were also observed in a smaller number of animals. All survivors receiving 2000 mg

Gross pathology:

The necropsy of animals dying following administration of ammonium bromide revealed fur staining, abnormal gastro-intestinal contents, dark areas on the lungs and occasional thymic petechiae. Animals killed on day 15 showed enlarged cervical lymph nodes in four males and a dark submandibular salivary gland in one male. None of these lesions were considered to be an effect of the test material.

Any other information on results incl. tables

Table 1: Summary of Acute Oral Toxicity

Dose [mg/kg]	Number of dead / number of investigated		Time of death (range) -	Observations -
	Male	Female
2000	0/5	0/5		Lethargic, unconscious, decreased motor activity, hunched, ataxia, prone, musculature tremor, bradypnoea, hyperpnoea, salivation, pigment of snout (duration of signs: 15 minutes – 2 days)
2714	1/5	4/5	½ - 1 hour	Lethargic, unconscious, decreased motor activity, hunched, ataxia, prone, bradypnoea, hyperpnoea, piloerection, ungroomed (duration of signs: 15 minutes – 5 days)
3684	5/5	5/5	½ - 48 hours	Lethargic, unconscious, decreased motor activity, hunched, ataxia, prone, tonic convulsions, bradypnoea, hyperpnoea, piloerection
5000	5/5	5/5	¼ - 1 hour	Prone, gasping
LD50value	2868 mg/kg bw (male); 2566 mg/kg bw (female), 2714 mg/kg bw (combined)

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 in this study was determined to be 2868 mg/kg bw (males), 2566 mg/kg bw (females) and 2714 mg/kg bw for both sexes combined.
In accordance with CLP Regulation (EC) No 1272/2008, ammonium bromide does not have to be classified and labelled with respect to acute oral toxicity.

Executive summary:

Materials and methods

The study was designed to investigate the acute oral toxicity of ammonium bromide in rats. The test material was administered to groups of five male and five female rats as a single oral dose of 2000, 2714, 3684 and 5000 mg/kg at a constant volume of 20 ml/kg in distilled water. Mortality, signs of reaction to treatment and body weight gain were recorded during a subsequent 14-day observation period after which LD50 was determined. Decendents and animals killed on day 15 were subjected to necropsy.

Results and discussion

The principal signs of reaction comprised lethargy, decreased motor activity, prone and hunched posture, ataxia and breathing difficulties. Unconsciousness and tonic convulsions were also observed in a smaller number of animals. Necropsy findings included fur staining, abnormal gastro-intestinal contents, dark areas on the lungs and occasional thymic petechiae. All survivors achieved anticipated bodyweight gains and necropsy findings on day 15 were unremarkable