Registration Dossier
Registration Dossier
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EC number: 234-717-7 | CAS number: 12027-06-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from authoritative database and safety assessment reports
Data source
Referenceopen allclose all
- Reference Type:
- secondary source
- Title:
- Ocular irritation study of the test chemical
- Author:
- EUROPEAN COMMISSION – European Chemicals Bureau
- Year:
- 2 000
- Bibliographic source:
- IUCLID Dataset, EUROPEAN COMMISSION – European Chemicals Bureau, last updated 2000
- Reference Type:
- other: Authoritative database
- Title:
- Ocular irritation study of the test chemical
- Author:
- U S National Library of Medicine
- Year:
- 2 015
- Bibliographic source:
- Hazardous Substance Databank[HSDB], U S National Library of Medicine, last updated 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: US EPA Pesticide Assessment Guidelines, 1982
- Principles of method if other than guideline:
- To assess eye irritation potential of the test chemical in rabbits
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Ammonium bromide
- Cas Number:
- 12124-97-9
- Molecular formula:
- BrH4N
- IUPAC Name:
- Ammonium bromide
- Details on test material:
- Name of the test chemical: Ammonium bromide
Molecular formula: NH4Br
Molecular Weight: 97.9426 g/mol
Substance Type: Inorganic
Physical State: Solid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- no data available
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- 0.1g
- Duration of treatment / exposure:
- single exposure
- Observation period (in vivo):
- 1, 24, 48 and 72 hours after treatment and on Day 8
- Duration of post- treatment incubation (in vitro):
- no data available
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- no data available
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 1 hour
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- probability of mild irritation
- Irritant / corrosive response data:
- The test chemical was considered to be slightly irritating to rabbit eyes.
- Other effects:
- A well– defined appearance to the conjunctival blood vessels, iridial congestion, a moderate or slight discharge and slight chemosis were observed in all rabbits one hour after treatment. No corneal lesions were observed. The observed changes resolved within 3 days after treatment and all eyes were normal on Day 8.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- A well– defined appearance to the conjunctival blood vessels, iridial congestion, a moderate or slight discharge and slight chemosis were observed in all rabbits one hour after treatment. No corneal lesions were observed. The observed changes resolved within 3 days after treatment.
The test chemical was considered to be slightly irritating to rabbit eyes. - Executive summary:
A study was performed according to US EPA Pesticide Assessment Guidelines, 1982 to assess the ocular irritation potential of the test chemical. 0.1 g undiluted test chemical was instilled in to the eyes of 6 New Zealand White rabbits and observed for effects. The treated eyes were assessed 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 in all rabbits one hour after treatment. No corneal lesions were observed. The observed changes resolved within 3 days after treatment and all eyes were normal by 8 days.The test chemical was considered to be slightly irritating to rabbit eyes.
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