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Toxicological information

Eye irritation

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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:
2000
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:
2015
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

Constituent 1
Chemical structure
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

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.