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Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
02/02/1982 to 29-05-1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Study not conducted to current guideline, however study is scientifically sound and acceptable for assessment. This study has been selected as the key study because the results are sufficient in order to derive a reliable conclusion on classification and labelling in accordance with Regulation (EC) No. 1272/2008 (EU CLP). Pentacalcium hydroxide tris(orthophosphate) is not considered to be classified according to Regulation (EC) No. 1272/2008 (EU CLP).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report date:
1985

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: US EPA Guidelines(24/05/1982) FR22405), OECD Guidelines (1981), and PR Notice 81-3
Deviations:
not specified
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1981
Deviations:
no
GLP compliance:
yes
Remarks:
however, study predates the introduction of GLP

Test material

Constituent 1
Chemical structure
Reference substance name:
Pentacalcium hydroxide tris(orthophosphate)
EC Number:
235-330-6
EC Name:
Pentacalcium hydroxide tris(orthophosphate)
Cas Number:
12167-74-7
Molecular formula:
Ca5HO13P3
IUPAC Name:
Calcium hydroxycalcium(1+) phosphate (4:1:3)
Constituent 2
Reference substance name:
tricalcium phosphate
IUPAC Name:
tricalcium phosphate

Test animals / tissue source

Species:
rabbit
Strain:
other: Stauffland albino
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Phillips Rabbitry, Soquel, CA
- Age at study initiation: no data
- Weight at study initiation: no data
- Housing: two in a cage in suspended steel cages (24" x 16.5 " x 14").
- Diet: ad libitum; Special Mixture, Gunter Bros., Morgan Hill, CA.
- Water: ad libitum
- Acclimation period: no data


ENVIRONMENTAL CONDITIONS
- Temperature: 65-70°F (18.3 - 21.1°C)
- no other data pertinent to environmental conditions.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
The solid test material was passed through a #300 mesh screen and the fines were used. 100mg of the test material was used.

VEHICLE
No vehicle used. The test material was not moistened before being placed in the eye.
Duration of treatment / exposure:
Three animals had their eyes washed 20-30 seconds after application and a further six animals did not.
Observation period (in vivo):
1, 24, 48 and 72 hours and then at 4 and 7 days post application.
If after 7 days irritation was present then additional observations would be made every 3-4 days.
Number of animals or in vitro replicates:
9
Details on study design:
REMOVAL OF TEST SUBSTANCE
20-30 seconds after application three animals had their eyes washed with luke warm water for one minute, the remaing six animals did not.

SCORING SYSTEM: The guidelines described by Draize (1965) were used to assign numerical scored to the observed effects.

TOOL USED TO ASSESS SCORE: fluorescein
Fluorescein staining was graded using a modified procedure outlined by the National Research Council (1977)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
24/48/72 h
Score:
0.17
Max. score:
3
Reversibility:
fully reversible within: 48 hrs
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Unwashed eyes: Three of the six animals exhibited a redness of the conjuctiva on day 1 after administration. No other effects were observed.
Washed eyes: All zero scores at all timepoints.

Any other information on results incl. tables

Individual eye scores for rabbits whose eyes were unwashed:

Animal No.

Irritation

Pre-dose

Day 1

Day

2

Day

3

Day

4

Day

7

82-M-341

Cornea:

opacity

0

0

0

0

0

0

Cornea:

area

0

0

0

0

0

0

Iris

0

0

0

0

0

0

Conjuctiva:

redness

0

0

0

0

0

0

Conjuctiva:

chemosis

0

0

0

0

0

0

Conjuctiva:

discharge

0

0

0

0

0

0

82-M-342

Cornea:

opacity

0

0

0

0

0

0

Cornea:

area

0

0

0

0

0

0

Iris

0

0

0

0

0

0

Conjuctiva:

redness

0

1

0

0

0

0

Conjuctiva:

chemosis

0

0

0

0

0

0

Conjuctiva:

discharge

0

0

0

0

0

0

82-M-343

Cornea:

opacity

0

0

0

0

0

0

Cornea:

area

0

0

0

0

0

0

Iris

0

0

0

0

0

0

Conjuctiva:

redness

0

0

0

0

0

0

Conjuctiva:

chemosis

0

0

0

0

0

0

Conjuctiva:

discharge

0

0

0

0

0

0

82-M-344

Cornea:

opacity

0

0

0

0

0

0

Cornea:

area

0

0

0

0

0

0

Iris

0

0

0

0

0

0

Conjuctiva:

redness

0

0

0

0

0

0

Conjuctiva:

chemosis

0

0

0

0

0

0

Conjuctiva:

discharge

0

0

0

0

0

0

82-M-345

Cornea:

opacity

0

0

0

0

0

0

Cornea:

area

0

0

0

0

0

0

Iris

0

0

0

0

0

0

Conjuctiva:

redness

0

1

0

0

0

0

Conjuctiva:

chemosis

0

0

0

0

0

0

Conjuctiva:

discharge

0

0

0

0

0

0

82-M-346

Cornea:

opacity

0

0

0

0

0

0

Cornea:

area

0

0

0

0

0

0

Iris

0

0

0

0

0

0

Conjuctiva:

redness

0

1

0

0

0

0

Conjuctiva:

chemosis

0

0

0

0

0

0

Conjuctiva:

discharge

0

0

0

0

0

0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test material was classed as a mild conjuctival irritant to the eyes of stauffland rabbits. Three of the six animals whose eyes were not washed after application exhibited a redness of the conjuctiva. All effects were reversed by day 2. Pentacalcium hydroxide tris(orthophosphate) is has not to be classified according to Regulation (EC) No. 1272/2008 (EU CLP).