Ammonium bromide

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1997-08-05 to 1997-09-09

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

Test material was spread over 5 % of body surface (4 cm x 6 cm) instead of 10%.

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPP 81-2 (Acute Dermal Toxicity)

Version / remarks:

Sub-Division F

Deviations:

yes

Remarks:

Test material was spread over 5 % of body surface (4 cm x 6 cm) instead of 10%.

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: EEC Directive 92/69/EEC, Annex V, Test B3, July 1992

Deviations:

yes

Remarks:

Test material was spread over 5 % of body surface (4 cm x 6 cm) instead of 10%.

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

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): Ammonium bromide
- Description: White crystalline solid
- Analytical purity: 98.5 %
- Lot/batch No.: Batch No. 970027/1
- Stability under test conditions: Single Dosing
- Storage condition of test material: Test material was stored in the dark under ambient conditions

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan UK, Shaw´s Farm, Blackthorn, Bicester, OX6 0TP
- Age at study initiation: 8-10 weeks
- Weight at study initiation: males: 256- 290 g, females: 213-262 g
- Fasting period before study:
- Housing: Individually in suspended polypropylene cages (42 x 27 x 20 cm) with stainless steel tops and bottoms
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 20°C
- Humidity (%): mean: 62%
- Air changes (per hr): 15 - 20
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle

IN-LIFE DATES: From: 1997-08-05 To: 1997-09-09

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: 4 cm x 6 cm
- % coverage: approximately 5 % of body surface
- Type of wrap if used: water moistened patches


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Sterile distilled water
- Time after start of exposure: 24 hours


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Dose Ranging: 500, 1000, 1500 and 2000 mg/kg bw
Limit Test: 40 mg/cm2 (comparable to 2000 mg/kg bw)
- Constant volume or concentration used: yes (Limit Test)

VEHICLE
Substance was applied as supplied; no vehicle used.

Duration of exposure:

24 hours

Doses:

Dose Ranging: 500, 1000, 1500 and 2000 mg/kg bw
Limit Test: 40 mg/cm2 (comparable to 2000 mg/kg bw)

No. of animals per sex per dose:

5/sex/group

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:Observation for reaction of treatment and viability were performed at least once per day for up to 14 days after dosing. Bodyweights were recorded on Day 1,8 and 15 during the main study. For dose ranging body weight was recorded on the day of dosing only.
- Necropsy of survivors performed: yes
- Other examinations performed: Clinical observations were conducted frequently on the day of dosing and daily thereafter until sacrifice on Day 8 (Dose Ranging) or Day 15 (Main Study).

Statistics:

No statistical analysis performed

Results and discussion

Preliminary study:

There were no premature deaths and no clinical signs noted throughout the observation period of the dose ranging study and in addition, no necropsy findings noted .

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No animals died prematurely.

Clinical signs:

other: Loose faeces (1 male, 2 female) and wet perigenital (1 female) on Day 1 and red test side (1 male, 1 female) on Day 2.

Gross pathology:

no necropsy findings noted

Any other information on results incl. tables

Table A6.1.2/01-1                    Summary of Acute Dermal Toxicity
Dose Level [mg/kg] / sex	Number of dead / number of investigated		Observations
2000/ male	0/5		Test side slightly red, few loose faeces
2000/ female	0/5		Test side slightly red, few loose faeces, wet pergenital area
LD50value	> 2000 mg/ kg bw

 

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of the study, the acute dermal LD50 of ammonium bromide was determined to be > 2000 mg/kg. In accordance with CLP Regulation (EC) No 1272/2008, no classification and labelling with respect to acute dermal toxicity is required.

Executive summary:

Materials and Methods

This study investigated the acute dermal toxicity of ammonium bromide after a single dermal administration to rats. Five male and five female rats were exposed to a 24 h dermal application of 2000 mg/kg of test substance, which was applied as supplied under occlusive water moistened patches onto skin which was clipped the day before. The animals were observed daily for reaction to treatment for up to 14 days after dosing.

Results and Discussion

Clinical signs were limited to loose faeces and wet perigenital on Day 1, and a red test side on Day 2. Application of ammonium bromide did not show influence on body weight gain. There were no premature decendents during the study and no necropsy findings noted.