Calcium bis(metaphosphate)

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

02 - 10 Jan 2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

refer to analogue justification provided in IUCLID section 13

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:

2012

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Dicalcium pyrophosphate

EC Number:

232-221-5

EC Name:

Dicalcium pyrophosphate

Cas Number:

7790-76-3

Molecular formula:

Ca2O7P2

IUPAC Name:

dicalcium diphosphate

Test material form:

solid: particulate/powder

Test animals / tissue source

Species:

rabbit

Strain:

other: New Zealand White (Hsdlf:NZW)

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: 2.61-2.93 kg
- Housing: The animals were individually housed in suspended cages. The animals were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.
- 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:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg

Duration of treatment / exposure:

single instillation without washing

Observation period (in vivo):

72 h
Reading time points: 1, 24, 48 and 72 h

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:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility not applicable

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility not applicable

Results 3

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: reversibility not applicable

Results 4

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: reversibility not applicable

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 h

Results 6

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 h

Results 7

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 8

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 h

Irritant / corrosive response data:

Individual scores for ocular irritation are given in Table 1. The individual and mean scores as required for EU 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 one treated eye and minimal conjunctival irritation was noted in the other treated eye one hour after treatment. Minimal conjunctival irritation noted in both treated eyes at the 24-hour observation.
Both treated eyes appeared normal at the 48-hour observation.

Other effects:

Individual bodyweights and bodyweight changes 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	72824 Male				72839 Male
	IPR = 1				IPR =2
Time After Treatment [h]	1	24	48	72	1	24	48	72
CORNEA Degree of opacity Area of cornea involved	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0
IRIS	1	0	0	0	1	0	0	0
CONJUNCTIVAE Redness Chemosis Discharge	1 1 1	1 1 0	0 0 0	0 0 0	1 2 2	1 1 1	0 0 0	0 0 0

 

IPR = Initial Pain Reaction

 

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

Rabbit Number and Sex	Time After Treatment [h]	Corneal Opacity	Iridial Inflammation	Conjunctival Redness	Conjunctival Chemosis
72824 Male	24 48 72	0 0 0	0 0 0	1 0 0	1 0 0
Mean		0.0	0.0	0.3	0.3
72839 Male	24 48 72	0 0 0	0 0 0	1 0 0	1 0 0
Mean		0.0	0.0	0.3	0.3

 

Table 3. Individual Body Weights and Body Weight Changes

Rabbit Number and Sex	Individual Body Weight (kg)		Body Weight Change (kg)
	Day 0	Day 3
72824 Male	2.93	3.00	0.07
72839 Male	2.61	2.68	0.07

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test item produced individual scores of 0/0 for corneal opacity, 0/0 for iritis, 0.3/0.3 for conjunctival redness and 0.3/0.3 for chemosis, calculated as the mean scores following grading at 24, 48 and 72 hour after instillation. Observed effects were fully reversible within the observation period.
Therefore, 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 and the Globally Harmonised System of Classification and Labelling of Chemicals.
The test item is thus considered to be not irritating to rabbit eyes.

CLP: not classified
GHS: not classified