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EC number: 232-076-8 | CAS number: 7785-23-1
Toxicological information
Eye irritation
Currently viewing:
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2013-03-28 to 2013-05-24
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- signed 2012-11-30
Test material
- Reference substance name:
- Silver bromide
- EC Number:
- 232-076-8
- EC Name:
- Silver bromide
- Cas Number:
- 7785-23-1
- Molecular formula:
- AgBr
- IUPAC Name:
- silver(1+) bromide
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Silver bromide
- Molecular formula: AgBr
- Physical state: yellow(ish), odourless, crystalline powder
- Storage condition of test material: room temperature in the dark
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Leicestershire, UK
- Age at study initiation: twelve to twenty weeks old
- Weight at study initiation: 2.58 to 2.87 kg
- Housing: animals were individually housed in suspended cages
- Diet (ad libitum): 2930C Teklad Global Rabbit diet (supplied by Harlan Laboratories UK Ltd., Oxon, UK)
- Water (ad libitum): mains drinking water
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature: 17 to 23°C
- Relative humidity: 30 to 70%
- Air exchanges: at least fifteen changes per hour
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg of the test item was placed into the conjunctival sac of the right eye, formed by gently pulling the lower lid away from the eyeball. The upper and lower eyelids were held together for about one second immediately after treatment, to prevent loss of the test item, and then released. The left eye remained untreated and was used for control purposes. - Duration of treatment / exposure:
- not applicable
- Observation period (in vivo):
- approximately 1 hour and 24, 48 and 72 hours following treatment
- Number of animals or in vitro replicates:
- 3 male rabbits
- Details on study design:
- Immediately before the start of the test, both eyes of the provisionally selected test rabbits were examined for evidence of ocular irritation or defect with the aid of a light source from a standard ophthalmoscope. Only animals free of ocular damage were used.
INITIAL TEST AND CONFIRMATORY TEST
Initially, a single rabbit was treated. Immediately after administration of the test item, an assessment of the initial pain reaction was made according to a six point scale (please refer to "Any other information on materials and methods incl. tables" below).
After consideration of the ocular responses produced in the first treated animal, two additional animals were treated.
SCORING SYSTEM: according to the Draize scale
Any other ocular effects were also noted.
Any clinical signs of toxicity were also recorded.
Individual body weights were recorded the day of dosing and at the end of the observation period.
TOOL USED TO ASSESS SCORE: examination of the eye was facilitated by the use of the light source from a standard ophthalmoscope.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: Initial pain reaction: slight initial pain; Slight discharge (grade 1) was observed at the one hour observation.
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- not specified
- Remarks on result:
- other: Slight iridial inflammation (grade 1) was observed at the one hour observation.
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: Moderate conjunctival redness (grade 2) was observed at the one hour observation.
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: Slight chemosis (grade 1) was observed at the one hour observation.
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: Initial pain reaction: slight initial pain; Slight discharge (grade 1) was observed at the one hour observation.
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- not specified
- Remarks on result:
- other: Slight iridial inflammation (grade 1) was observed at the one hour observation.
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: Moderate conjunctival redness (grade 2) was observed at the one hour observation.
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: Slight chemosis (grade 1) was observed at the one hour observation.
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: Initial pain reaction: slight initial pain; Slight discharge (grade 1) was observed at the one hour observation.
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- not specified
- Remarks on result:
- other: Slight iridial inflammation (grade 1) was observed at the one hour observation.
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: Moderate conjunctival redness (grade 2) was observed at the one hour observation.
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: Moderate chemosis (grade 2) was observed at the one hour observation.
- Irritant / corrosive response data:
- No corneal effects were noted during the study.
Iridial inflammation was noted in all treated eyes one hour after treatment.
Moderate conjunctival irritation was noted in all treated eyes one hour after treatment. Moderate conjunctival irritation was noted in one treated eye and minimal conjunctival irritation was noted in two treated eyes at the 24-hour observation with minimal conjunctival irritation noted in all treated eyes at the 48-hour observation.
All treated eyes appeared normal at the 72-hour observation. - Other effects:
- All animals showed expected gain in body weight during the study.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Silver bromide is not irritating to the eyes.
- Conclusions:
- The test substance is not irritating to the eyes.
According to the EC-Commission directive 67/548/EEC and its subsequent amendments, the test substance is not irritating to the eyes.
According to the EC-Regulation 1272/2008 and subsequent regulations, the test item is not classified as eye irritant.
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