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Description of key information

Skin: No dermal irritation responses were observed in any animal at any reading time point during the observation period
Eye: 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. Four out of six rabbits showed conjunctival redness over the 24 - 72 hour observation period with a mean score of 2. The substance is classified and labelled with respect to ocular irritantcy in accordance with Regulation (EC) No. 1272/2008.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1986-07-01 to 1986-07-04
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EPA OPP 81-5 (Acute Dermal Irritation)
Deviations:
yes
Remarks:
Six female rabbits were used for the study and observed up to 72-hours post-exposure only
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
Six female rabbits were used for the study and observed up to 72-hours post-exposure only
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Froxfield S.P.F. Rabbits, Broadway Farm, Froxfield, Hampshire, England
- Age at study initiation: three months
- Weight at study initiation: 2.16-3.06 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 6 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: 1986-07-01 To: 1986-07-04
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: right test site of each animal was used as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g/animal
Duration of treatment / exposure:
4 hours
Observation period:
3 days
Number of animals:
6 females
Details on study design:
TEST SITE
- Area of exposure: 6 x 6 cm

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Gentle wash with warm water
- Time after start of exposure: 4 hours


SCORING SYSTEM:
Scoring system as given in OECD guideline 404
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable; no erythema formation.
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable; no oedema formation
Other effects:
none

Table A6.1.4/01-1          Results of skin irritation study

score (average animals investigated)

time

Erythema

Edema

average score
Draize scores
(0 to maximum 4)

60 min

0

0

24 h

0

0

48 h

0

0

72 h

0

0

average score

24h, 48h, 72h

0

0

reversibility: *

-

-

average time for reversibility

-

-

*     c :     completely reversible
    n c :     not completely reversible
       n :     not reversible

 

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this test Ammonium Bromide was designated `non-irritant` to skin. In accordance with CLP Regulation (EC) No 1272/2008, no classification and labelling with respect to dermal irritation is required.
Executive summary:

Materials and Methods

The objective was to asses the potential of Ammonium Bromide to cause inflammatory or corrosive changes upon first contact with skin. A quantity of 0.5 g of test material was applied semi-occluded to six New Zealand White Rabbits for four hours. Dermal reactions were assessed 1, 24, 48 and 72 hours after removal of the dressings.

Results and Discussion

No dermal irritation responses were observed in any animal at any reading time point during the observation period.

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EPA OPP 81-5 (Acute Dermal Irritation)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
no
Amount / concentration applied:
other: 0.5 g in 0.5 ml



Duration of treatment / exposure:
4 hour(s)

Observation period:
4 days
Number of animals:
6
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: all
Score:
0
Other effects:
no furher details
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In accordance with CLP Regulation (EC) No 1272/2008, no classification and labelling with respect to skin irritation is required.
Executive summary:

The test substance was moistened with water and administered dermally to a small patch of shaven skin of 6 female rabbits and covered for 4 hours each. Observations of the resulting skin condition were made 30 minutes after test substance removal, and daily thereafter for 4 days.

All 6 animals showed no response to treatment.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

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
Qualifier:
according to guideline
Guideline:
EPA OPP 81-4 (Acute Eye Irritation)
Deviations:
no
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
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
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

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
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0.2
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
1.7
Max. score:
2
Reversibility:
fully reversible within: 8 days
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

 

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

 

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.

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EPA OPP 81-4 (Acute Eye Irritation)
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Buckmasters, Henham, Hertfordshire, England
- Age at study initiation: approximately 13-16 weeks
- Weight at study initiation: 3-3.7 kg
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
undiluted
Amount applied: 94 other: mg

Duration of treatment / exposure:
unspecified: following instillation of the test material, the treated eye remained unwashed throughout the entire observation period.

Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6 males
Details on study design:
Comment: not rinsed

SCORING SYSTEM:
Scoring system similar to description in OECD guideline No. 405.
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 60-168 h
Score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 60-168 h
Score:
0
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
other: 24-72 h
Score:
0.56
Reversibility:
fully reversible within: 72 h
Irritation parameter:
cornea opacity score
Remarks:
discharge
Basis:
mean
Time point:
other: 24-72 h
Score:
1.5
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24-72 h
Score:
0.6
Reversibility:
fully reversible within: 24 h
Irritant / corrosive response data:
No corneal damage or iridial inflammation was observed. Mild conjunctival irritation in all six animals, three of these animals showed obvious swelling with partial eversion of the lids.
Other effects:
no further details
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the observations made on the eyes in all individual animals and considering the provisions laid down in CLP Regulation (EC) No 1272/2008 for the assessment of the eye irritancy of a substance, sodium bromide is not regarded to be ´irritating` to the eyes of rabbits. No classification and labelling with respect to eye irritancy is, therefore, required

Executive summary:

94 Milligrams of the test substance was applied to one eye of each of 6 male rabbits and held in place for 1 second in each case. Observations of the resulting eye condition were made 60 minutes after test substance application, and again after 1, 2, 3, 4 and 7 days.

Average scores (for days 1 to 3): cornea – 0; iris – 0; conjunctiva redness – 0.56, chemosis – 0.6 and discharge – 1.5.

All irritant effects observed were reversed within 1 to 3 days.

The substance is classed as ‘slightly irritating’ under the classification system used in the study.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin

A quantity of 0.5 g of test material was applied semi-occluded to six New Zealand White Rabbits for four hours. Dermal reactions were assessed 1, 24, 48 and 72 hours after removal of the dressings. No dermal irritation responses were observed in any animal at any reading time point during the observation period.

Eye

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. 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. Four out of six rabbits showed conjunctival redness over the 24 - 72 hour observation period with a mean score of 2. The substance is classified and labelled with respect to ocular irritanct in accordance with Regulation (EC) No. 1272/2008.


Effects on skin: not irritating

Effects on eye: irritating

Justification for classification or non-classification

Based on the in vivo experimental results, ammonium bromide is classified as irritating to eyes.