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Diss Factsheets

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:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
data is from safety assessment reports

Data source

Reference
Reference Type:
secondary source
Title:
INVENTORY MULTI-TIERED ASSESSMENT AND PRIORITISATION (IMAP) - NICNAS
Author:
National Industrial Chemicals Notification and Assessment Scheme (NICNAS)
Year:
2018
Bibliographic source:
INVENTORY MULTI-TIERED ASSESSMENT AND PRIORITISATION (IMAP) - NICNAS, 2018

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
To assess the eye irritation potential of the test chemical in rabbits
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Manganese bis(dihydrogen phosphate)
EC Number:
242-520-2
EC Name:
Manganese bis(dihydrogen phosphate)
Cas Number:
18718-07-5
Molecular formula:
H3O4P.1/2Mn
IUPAC Name:
Manganese bis(dihydrogen phosphate)
Test material form:
solid
Details on test material:
Name of the test chemical: Manganese bis(dihydrogen phosphate)
Molecular Formula:H3O4P.1/2Mn
Molecular Weight: 249 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:
sex: female

Test system

Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
100 mg
Duration of treatment / exposure:
single exposure
Observation period (in vivo):
24, 48 and 72 hour time-points till 10 days
Duration of post- treatment incubation (in vitro):
no data available
Number of animals or in vitro replicates:
3 female
Details on study design:
No data available

Results and discussion

In vitro

Other effects / acceptance of results:
No data available

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
positive indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 10 days
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
positive indication of irritation
Irritant / corrosive response data:
chemosis was not fully reversed within seven days in one rabbit; conjunctival redness was fully reversible within 10 days; corneal opacity was not fully reversed within 72 hours in one rabbit

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
The average score for corneal opacity was 0.33/4 for all animals over the 24, 48 and 72 hour time-points, it was not fully reversed within 72 hours in one rabbit. There was no iritis in any rabbit over the duration of the study. The average score for conjunctival redness was 3/3 for all animals over the 24, 48 and 72 hour time-points, but this was fully reversible within 10 days. The average score for chemosis was 3/4 for all animals over the 24, 48 and 72 hour time-points and chemosis was not fully reversed within seven days in one rabbit.
Since the most of the effects were not reversible by 10 days, the test chemical can be considered to be irritating to eyes.
Executive summary:

The ocular irritation potential of the test chemical was assessed in rabbits according to OECD 405 Guidelines. 100 mg of undiluted test chemical was instilled in the eyes of 3 female New Zealand White rabbits and observed for signs of irritation till 10 days.It was observed that corneal opacity was minimal (average 0.33/4 for all animals over the 24, 48 and 72 hour time-points), but that it was not fully reversed within 72 hours in one rabbit. There was no iritis in any rabbit over the duration of the study. The average score for conjunctival redness was 3/3 for all animals over the 24, 48 and 72 hour time-points, but this was fully reversible within 10 days. The average score for chemosis was 3/4 for all animals over the 24, 48 and 72 hour time-points and chemosis was not fully reversed within seven days in one rabbit.

Since the most of the effects were not reversible by 10 days, the test chemical can be considered to be irritating to eyes.