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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1988
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: EPA FIFRA 81-6
Deviations:
no
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
equivalent or similar to guideline
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium bromide
EC Number:
231-599-9
EC Name:
Sodium bromide
Cas Number:
7647-15-6
Molecular formula:
NaBr
IUPAC Name:
Active bromine generated from sodium bromide and sodium hypochlorite
Details on test material:
- Name of test material (as cited in study report): Sodium bromide, technical grade
- Description: White powder
- Analytical purity: 99.23 %
- Lot/batch No.: 7320
Ammonium bromide is an inorganic salt that dissociates to its composite ions in aqueous solutions at environmental pH and temperature. Comparison of the available data on the various bromide salts have shown that the bromide ion is the relevant ion for determination of the toxicological profile with simple cations such as potassium, sodium or ammonium, that are ubiquitous in nature, having little or no influence on the bromide ion properties. It is therefore justified to read-across data from other inorganic bromide salts to ammonium bromide.

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Froxfield Rabbits, Petersfield, Hampshire, England
- Age at study initiation: 9-13 weeks
- Weight at study initiation: 2090-2900 g

Administration / exposure

Type of coverage:
occlusive
Vehicle:
water
Details on dermal exposure:
TEST SITE
- % coverage: 10 % of body surface

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Warm water (30-40°C)
- Time after start of exposure: 24 hours


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2 g/kg bw
- Concentration (if solution): the test substance was moistened at 1 mL/kg with distilled water
- Constant volume or concentration used: yes
- For solids, paste formed: yes; the test substance was moistened at 1 mL/kg with distilled water


VEHICLE
- Amount(s) applied (volume or weight with unit): 1 mL
Duration of exposure:
24 hours
Doses:
2 g/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 clinical signs and dermal irritation soon after dosing, then at frequent intervals for the remainder of Day 1. On subsequent days the animals were examined at least twice for 14 days. Body weights were taken on Day 1, 8 and 15 and at death.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
One male rabbit was found dead on Day 2. There were no clinical signs recorded prior to death. A slight loss in bodyweight was recorded. Autopsy revealed congestion of the lungs. No other macroscopic abnormalities were observed. The death of this animal was not considered to be treatment related.
Clinical signs:
There were no clinical signs of toxicity seen in any of the treated animals including those found dead. No dermal irritation was observed at the treated skin sites of any of the animals throughout the fourteen day study.
Body weight:
A slightly low body weight gain was recorded for one of the female rabbits in the first week of the study. All other animals achieved anticipated bodyweight gains.
Gross pathology:
One rabbit showed small pale areas on the liver. Some of these contained a purulent material. One male rabbit that died during the study showed congestion of the lungs. Terminal autopsy findings of all other rabbits were normal.

Any other information on results incl. tables

 

Table A6.1.2/02-1                          Summary of Acute Dermal Toxicity

Dose [g/kg] / sex

Number of dead /
number of investigated

Time of death (range)

Observations

2 / male

1/5

Day 2

No treatment related observations

2 / female

0/5

 

No treatment related observations

LD50value

> 2 g/kg body weight

 

 

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute dermal LD50 in male and female rabbits was determined to be greater than 2000 mg/kg. In accordance with CLP Regulation (EC) No 1272/2008, sodium bromide does not have to be classified and labelled with respect to acute dermal toxicity.
Executive summary:

Materials and Methods

The study was designed to assess the dermal toxicity of sodium bromide. Five male and five female rabbits were exposed to a single dermal dose of 2 g/kg bodyweight sodium bromide moistened at 1 mL/kg with distilled water. The treated skin area was clipped the day before. Animals were observed daily for mortality and clinical signs for dermal irritation and toxicity. Body weights were recorded once per week. Autopsy was performed for all rabbits at termination of the study.

Results and Discussion

No clinical signs or dermal irritation was observed at the treated skin sites of both surviving and decedent animals. A slightly low body weight gain was recorded for one of the female rabbits in the first week of the study. All other animals achieved anticipated bodyweight gains. One male rabbit was found dead on Day 2. Autopsy revealed congestion of the lungs. No other abnormalities were observed and there were no clinical signs recorded prior to death. The death of this animal was not considered to be treatment related.

The LD50 >2000 mg/kg bw (both sexes) (equivalent to: >1552 mg (Br-)/kg bw (both sexes)).