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EC number: 231-830-3 | CAS number: 7758-02-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1995-09-18 to 1995-10-04
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP study conducted in compliance with OECD Guideline 405 and EU Method B5 with minor deviation: animals were not weighed at the end of study.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- animals were not weighed at the end of study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Potassium bromide
- EC Number:
- 231-830-3
- EC Name:
- Potassium bromide
- Cas Number:
- 7758-02-3
- Molecular formula:
- BrK
- IUPAC Name:
- potassium bromide
- Test material form:
- other: crystalline solid
- Details on test material:
- - Name of test material (as cited in study report): Potassium bromide
- Physical state: White crystalline solid
- Lot/batch No.: 950103
- Date of receipt: 25 August 1995
- Storage condition of test material: Room temperature over silica gel
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd., Sandbach, UK.
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.42-2.73 kg
- Housing: Animals were individually housed in suspended metal cages.
- Diet: Food (Teklad Rabbit Diet 9603, Harlan Teklad, Bicester, UK), ad libitum
- Water: Mains drinking water, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 17-21 °C
- Humidity: 56-68 %
- Air changes: Approximately 15 changes/hour
- Photoperiod: 12 hours dark / 12 hours light
IN-LIFE DATES: From: 1995-09-18 To: 1995-10-04
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg - Duration of treatment / exposure:
- Eyes were not rinsed throughout study
- Observation period (in vivo):
- 14 days
- Number of animals or in vitro replicates:
- 3 (1 male and 2 females)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: No
SCORING SYSTEM: Draize method
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- - Dulling of the normal lustre of the corneal surface was confined to one treated eye 1 hour after treatment. Diffuse corneal opacity was noted in all treated eyes at the 24 and 48 hour observations and persisted in one eye at the 72 hour and 7 day observations. Slight vascularisation along the bottom edge of the cornea, approximately 2 mm in length and invading up to 1 mm onto the cornea was noted in one treated eye at the 7-day observation. No other corneal effects were noted.
- Iridial inflammation was noted in all treated eyes one hour after treatment, at the 24 and 48-hour observations and in two treated eyes at 72-hour observation. No other iridial effects were noted.
- Moderate conjunctival irritation was noted in all treated eyes one hour after treatment and at 24, 48 and 72-hour observations. Minimal conjunctival irritation was noted in two treated eyes at 7 days observation. Petechial haemorrhage of the nictitating membrane was noted in one treated eye one hour after treatment. Haemorrhage of the nictitating membrane was noted in all treated eyes at the 24, 48 and 72-hour observations and in one treated eye at the 7 days observation.
- Treated eyes appeared normal within 7 or 14 days after treatment. - Other effects:
- No data
Any other information on results incl. tables
Table 7.3.2/1: Results of eye irritation
Animal no. |
578 Male |
31 Female |
34 Female |
|||||||||||||||
|
Conjunctiva |
Iris |
Cornea |
Conjunctiva |
Iris |
Cornea |
Conjunctiva |
Iris |
Cornea |
|||||||||
|
A |
B |
C |
D |
E |
F |
A |
B |
C |
D |
E |
F |
A |
B |
C |
D |
E |
F |
1 h |
2pt |
2 |
3 |
1 |
d |
2 |
2 |
2 |
2 |
1 |
0 |
0 |
2 |
2 |
3 |
1 |
0 |
0 |
24 h |
2H |
2 |
3 |
1 |
1 |
2 |
2H |
2 |
3 |
1 |
1 |
1 |
2H |
2 |
2 |
1 |
1 |
2 |
48 h |
2H |
2 |
0 |
1 |
1 |
2 |
2H |
1 |
2 |
1 |
1 |
1 |
2H |
1 |
1 |
1 |
1 |
1 |
72 h |
2H |
2 |
0 |
1 |
1 |
2 |
2H |
1 |
1 |
0 |
0 |
0 |
2H |
1 |
1 |
1 |
0 |
0 |
Mean |
2 |
2 |
- |
1 |
1 |
- |
2 |
1.3 |
- |
0.7 |
0.7 |
- |
2 |
1.3 |
- |
1 |
0.7 |
- |
Day 7 |
1H |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0V |
0 |
Day 14 |
0 |
0 |
0 |
0 |
0 |
0 |
- |
- |
- |
- |
- |
- |
0 |
0 |
0 |
0 |
0 |
0 |
A: Redness; B: Chemosis; C: Discharge; D: Iris lesion; E: Degree of opacity; F: Area of opacity; H: Haemorrhage of the nictitating membrane; V: slight vascularisation along bottom edge of the cornea, approximately 2 mm in length and invading up to 1 mm onto the cornea; d: dulling of the normal lustre of the corneal surface; Pt: petechial haemorrhage of the nictitating membrane
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the test conditions, Potassium bromide is classified as "R36 irritating to eyes" according to the criteria of Annex VI to the Directive 67/548/EEC and "Category 2 irritating to eyes" according to CLP Regulation (EC) N° (1272-2008).
- Executive summary:
In an eye irritation study conducted according to the OECD Guideline 405 and EU Method B5 and in compliance with GLP, 3 New Zealand White rabbits were exposed to 100 mg of Potassium bromide in their right eye while the left eye remained untreated and served as control. The eyelids were then gently held together for about one second to avoid any loss of test item. The eyes were examined and the changes were observed at 1, 24, 48 and 72 hours and 7 and 14 days after treatment and graded according to the Draize method.
Dulling of the normal lustre of the corneal surface was confined to one treated eye 1 hour after treatment. Diffuse corneal opacity was noted in all treated eyes at the 24 and 48 hour observations and persisted in one eye at the 72 hour and 7 day observations. Slight vascularisation along the bottom edge of the cornea, approximately 2 mm in length and invading up to 1 mm onto the cornea was noted in one treated eye at the 7-day observation. No other corneal effects were noted. Iridial inflammation was noted in all treated eyes one hour after treatment, at the 24 and 48-hour observations and in two treated eyes at 72-hour observation. No other iridial effects were noted. Moderate conjunctival irritation was noted in all treated eyes one hour after treatment and at 24, 48 and 72-hour observations. Minimal conjunctival irritation was noted in two treated eyes at 7 days observation. Petechial haemorrhage of the nictitating membrane was noted in one treated eye one hour after treatment. Haemorrhage of the nictitating membrane was noted in all treated eyes at the 24, 48 and 72-hour observations and in one treated eye at the 7 days observation. Treated eyes appeared normal within 7 or 14 days after treatment. Mean individual scores at 24, 48 and 72 h after exposure for the 3 animals were 1, 0.7, 0.7 for cornea score; 1, 0.7, 1 for iris score; 2, 2, 2 for conjunctivae score and 2, 1.3, 1.3 for chemosis score. In this study, Potassium bromide is an eye irritant on rabbits.
Under the test conditions, Potassium bromide is classified as "R36 irritating to eyes" according to the criteria of Annex VI to the Directive 67/548/EEC and "Category 2 irritating to eyes" according to CLP Regulation (EC) N° (1272-2008).
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