Trimanganese bis(orthophosphate)

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

14 - 31 Jan 2013

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

2002-04-24

Deviations:

yes

Remarks:

only 1 animal (instead of 2) was tested in the confirmatory test

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Version / remarks:

2008

Deviations:

yes

Remarks:

only 1 animal (instead of 2) was tested in the confirmatory test

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Trimanganese bis(orthophosphate)

EC Number:

237-997-9

EC Name:

Trimanganese bis(orthophosphate)

Cas Number:

14154-09-7

Molecular formula:

Mn3O8P2

IUPAC Name:

trimanganese bis(orthophosphate)

Test material form:

solid: particulate/powder

Details on test material:

- Physical state: pink crystalline solid

Specific details on test material used for the study:

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature in the dark

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: 12-20 weeks
- Weight at study initiation: 2.14-2.62 kg
- Housing: animals were individually housed in suspended cages.
- Diet: 2930C Teklad Global Rabbit diet (Harlan Laboratories UK Ltd., Oxon, UK), ad libitum
- Water: mains drinking water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): at least 15
- 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): 0.1 mL (ca. 93 mg)

Duration of treatment / exposure:

single instillation without washing

Observation period (in vivo):

up to 7 days
Reading time points: 1, 24, 48 and 72 h and 7 days

Number of animals or in vitro replicates:

2

Details on study design:

SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: ophthalmoscope

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

animal '2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 3

Irritation parameter:

iris score

Basis:

mean

Remarks:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 4

Irritation parameter:

iris score

Basis:

mean

Remarks:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 5

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 6

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

animal #2

Time point:

24/48/72 h

Score:

0.7

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Results 7

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 8

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

animal #2

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Irritant / corrosive response data:

Individual scores for ocular irritation are given in Table 1. The individual and mean scores as required for EC and GHS classification and labelling are presented in Table 2.
No corneal effects were noted during the study.
Iridial inflammation was noted in both treated eyes one hour after treatment.
Moderate conjunctival irritation was noted in both treated eyes one hour after treatment. Minimal conjunctival irritation was noted in both treated eyes at the 24 and 48-Hour observations and in one treated eye at the 72-Hour observation.
One treated eye appeared normal at the 72-Hour observation and the other treated eye appeared normal at the 7-Day observation.

Other effects:

Individual bodyweights and bodyweight change are given in Table 3.
Both animals showed expected gain in bodyweight during the study.
No further local or systemic effects were observed during the study period.

Any other information on results incl. tables

Table 1 Individual Scores for Ocular Irritation

Rabbit Number and Sex	72876 Male					72927 Male
	IPR = 2					IPR = 2
Time After Treatment	1 Hour	24 Hours	48 Hours	72 Hours	7 Days	1 Hour	24 Hours	48 Hours	72 Hours
CORNEA
Degree of Opacity	0	0	0	0	0	0	0	0	0
Area of Cornea Involved	0	0	0	0	0	0	0	0	0
IRIS	1	0	0	0	0	1	0	0	0
CONJUNCTIVAE
Redness	2	1	1	1	0	2	1	1	0
Chemosis	2	1	1	1	0	2	1	0	0
Discharge	1	0	0	0	0	1	1	0	0

IPR = Initial Pain Reaction

Table 2 Individual and Mean Scores for Cornea, Iris and Conjunctivae

Rabbit Number and Sex	Time After Treatment	Corneal Opacity	Iridial Inflammation	Conjuctival Redness	Conjunctival Chemosis
72876 Male	24 Hours	0	0	1	1
	48 Hours	0	0	1	1
	72 Hours	0	0	1	1
Mean		0.0	0.0	1.0	1.0
72827 Male	24 Hours	0	0	1	1
	48 Hours	0	0	1	0
	72 Hours	0	0	0	0
Mean		0.0	0.0	0.7	0.3

Table 3 Individual Bodyweights and Bodyweight Change

Rabbit Number and Sex	Individual Bodyweight (kg)		Bodyweight Change (kg)
72876 Male	Day 0	Day 7	0.14
	2.62	2.76
72972 Male	Day 0	Day 3	0.04
	2.14	2.18

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The substance is not irritating to the eyes.
According to the EC Regulation No. 1272/2008 and subsequent adaptations, the substance is not classified as an eye irritant.

Executive summary:

Introduction

The study was performed to assess the irritancy potential of the test item to the eye of the New Zealand White rabbit. The method was designed to be compatible with the following:

 OECD Guideline for the Testing of Chemicals No. 405 “Acute Eye Irritation/Corrosion” (adopted 24 April 2002)

 Method B5 Acute Toxicity (Eye Irritation) of Commission Regulation (EC) No. 440/2008

Result

A single application of the test item to the non-irrigated eye of two rabbits produced iridial inflammation and moderate conjunctival irritation. One treated eye appeared normal at the 72-Hour observation and the other treated eye appeared normal at the 7-Day observation.

Conclusion

The test item produced individual scores of 0/0 for corneal opacity, 0/0 for iritis, 1.0/0.7 for conjunctival redness and 1.0/0.3 for chemosis, calculated as the mean scores following grading at 24, 48 and 72 hour after instillation in both tested animals. Observed effects were fully reversible within the observation period.

The test item does not meet the criteria for classification according to Regulation (EC) No 1272/2008, relating to the Classification, Labelling and Packaging of Substances and Mixtures.

The test item does not meet the criteria for classification according to the Globally Harmonized System of Classification and Labelling of Chemicals.

The test item is thus considered to be non-irritating to rabbit eyes.