Ammonium bromide

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1986-07-21 to 1986-07-29

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:

1986

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EPA OPP 81-4 (Acute Eye Irritation)

Deviations:

no

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

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

Test material form:

solid

Details on test material:

- Name of test material (as cited in study report): Ammonium bromide
- Description: white crystalline powder
- Analytical purity: not stated
- Lot/batch No.: 5230
- Stability under test conditions: not stated
- Storage condition of test material: at ambient temperature in the original container

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Froxfield S.P.F. Rabbits, Broadway Farm, Froxfield, Hampshire, England
- Age at study initiation: at least three month
- Weight at study initiation: 3.15-3.92 kg
- Housing: Individually in suspended steel cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15 - 23°C
- Humidity (%): 40 - 70%
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle

IN-LIFE DATES: From: 1986-07-21 To: 1986-07-29

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g

Duration of treatment / exposure:

not applicable, following instillation of the test material, the treated eye remained unwashed throughout the entire observation period.

Observation period (in vivo):

8 days

Number of animals or in vitro replicates:

6 females

Details on study design:

SCORING SYSTEM:
Scoring system similar to OECD guideline No. 404

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable; no corneal lesions observed

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0.2

Max. score:

1

Reversibility:

fully reversible within: 48 hours

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

1.7

Max. score:

2

Reversibility:

fully reversible within: 8 days

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0.3

Max. score:

1

Reversibility:

fully reversible within: 72 hours

Other effects:

Instillation of the test material caused moderate or slight initial pain responses among the animals.
No substance-related clinical signs of toxicity were observed.
Ocular findings were characterised by a well-defined appearance to the conjunctival blood vessels, iridial congestion, a moderate or slight discharge and slight chemosis amongst all the animals one hour after installation of ammonium bromide. No corneal lesions were observed

Any other information on results incl. tables

Table A6.1.4/04-1          Results of eye irritation study
	Cornea						Iris						Conjunctiva-redness						Conjunctiva-chemosis
Rabbit No.	1	2	3	4	5	6	1	2	3	4	5	6	1	2	3	4	5	6	1	2	3	4	5	6
1 hour	0	0	0	0	0	0	1	1	1	1	1	1	2	2	2	2	2	2	1	1	0	1	1	1
24 hours	0	0	0	0	0	0	0	0	1	1	0	1	2	2	1	2	2	2	0	0	0	1	1	0
48 hours	0	0	0	0	0	0	0	0	0	0	0	0	2	2	1	2	2	1	0	1	0	1	1	0
72 hours	0	0	0	0	0	0	0	0	0	0	0	0	2	2	0	2	2	1	0	0	0	0	0	0
8 days	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
mean scores 24-72 h	0						0.2						1.7						0.3
Classification	Non-irritant

 

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information CLP Cat 2 Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of the test and taking into consideration the provision laid down in Directive 2001/59/EC, ammonium bromide is considered to be ´irritating` to the eye and is classified and labelled with respect to ocular irritancy.

Executive summary:

Materials and Methods

The study was designed to test for acute eye irritation/corrosion of ammonium bromide. Six rabbits were subject to single ocular instillation of 0.1 g of test material into the right eye. The left eye remained untreated and served as control. Reactions of conjunctivae, iris and cornea were examined 1, 24, 48 and 72 hours after treatment and on day 8.

Results and Discussion

A well-defined appearance to the conjunctival blood vessels, iridial congestion, a moderate or slight discharge and slight chemosis, were observed amongst all the animals one hour after installation of ammonium bromide. No corneal lesions were observed. Gradual resolution was apparent over the following three days. All ocular irritation responses had resolved on day 8.