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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Remarks:
In vivo. Study was performed prior to the update of the REACH Regulation and prior to the validation of in vitro test methods.
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 07/08/1986 to 12/08/1986
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
Only two animals were tested per category (washed/unwashed eyes) not the three animals stipulated in the guideline. Effects were not severe in those animals tested.
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Pentapotassium triphosphate
EC Number:
237-574-9
EC Name:
Pentapotassium triphosphate
Cas Number:
13845-36-8
Molecular formula:
H5O10P3.5K
IUPAC Name:
pentapotassium triphosphate
Details on test material:
- Name of test material (as cited in study report): Potassium Tripolyphosphate
- Chemical composition: K5P3O10
- Substance type: White powder
- Physical state: solid
- Analytical purity: >99%
- Stability under test conditions: stable indefinitely
- Storage condition of test material: room temperature
- Other:

Test material received 05-03-1986,
Reference No. 527P 3116W
FMC-T#: 428

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hazleton Research Animals, Inc., Denver, Pennsylvania on July 16th, 1986
- Age at study initiation: The animals were young.
- Weight at study initiation: 2.36-2.77 kg
- Housing: Individual stainless steel cages, DAGB cageboard bedding was used in litter pans.
- Diet (e.g. ad libitum): Purina High Fiber Rabbit Chow 5326, ad libitum
- Water (e.g. ad libitum): fresh tap water ad libitum
- Acclimation period: July 16th 1986 - August 7th 1986


ENVIRONMENTAL CONDITIONS
- Temperature (°F): 68 - 75 °F
- Humidity (%): 56 - 61 %
- Photoperiod (hrs dark / hrs light): 12 hours fluorescent light, 12 hours dark cycle.


IN-LIFE DATES: From: 16/07/1986 To: 12/08/1986

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: yes, the untreated left eyes served as controls.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.10 gram
Duration of treatment / exposure:
washed eyes: exposure was 20-30 seconds before the eye were rinsed.
not washed: The test material was not removed by any external processes.
Observation period (in vivo):
4 days
Number of animals or in vitro replicates:
4
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): 2 of the 4 animals had their eye washed, the remaining 2 did not.
- Time after start of exposure: 20-30 seconds after treatment.
- The washed eyes were rinsed with 100 mL of tap water for 1 minute.

SCORING SYSTEM: Eyes were assessed for irritation using the method of Draize.

TOOL USED TO ASSESS SCORE: The eyes were examined with the aid of 2% fluorescein dye

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 96 hours
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritant / corrosive response data:
See Table 1. One hour after dosing mild conjunctivitis was noted in all eyes. Washed eyes recovered within 24 hours of dosing, at which time both of the unwashed eyes had slight conjunctivitis. At the 48 and 72 hour scoring, one unwashed rabbit still had slight conjunctivitis. By day 4, all irritation had resolved and the test was terminated.
Washing the eyes with tap water shortly after exposure decreased both the severity and duration of the irritation observed.
Other effects:
All animals remained healthy throughout the study, except one of the rabbits subject to eye washing, this rabbit had diarrhea at 72 hours and on day 4.

Any other information on results incl. tables

Table -1. Eye scores per animal.

Animal

Time point (hours)

Cornea opacity/area

Iris Iritis

Conjunctiva

Other comments

Redness

Chemosis

Discharge

1

1

0

0

1

1

3

0

24

0

0

1

0

1

0

48

0

0

0

0

0

0

72

0

0

0

0

0

0

96

0

0

0

0

0

0

 

2

1

0

0

1

1

2

Cb*

24

0

0

1

1

1

0

48

0

0

1

0

1

0

72

0

0

1

0

0

0

96

0

0

0

0

0

0

 

3 washed eyes

1

0

0

0

1

3

0

24

0

0

0

0

0

0

48

0

0

0

0

0

0

72

0

0

0

0

0

0

96

0

0

0

0

0

0

 

4 washed eyes

1

0

0

0

0

0

0

24

0

0

0

0

0

0

48

0

0

0

0

0

0

72

0

0

0

0

0

0

96

0

0

0

0

0

0

*Cb- conjunctiva red (bloody spots)

Table 2 - Primary eye irritation indexes

Scoring intervals

Unwashed

Washed

1h

9.0

8.0

24 h

5.0

0

48 h

2.0

0

72 h

1.0

0

96 h (day 4)

0

0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Although the study has only been conducted on two animals (unwashed eyes) it is considered to be sufficient for classification and labelling due to the minimal effects noted. This study is therefore submitted as a key study to provide the relevant classification according to Regulation (EC) No. 1272/2008 (EU CLP)