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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Remarks:
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:
1986-08-11 to 1986-08-15
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:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
eyes were irrigated after 20 - 30 sec, rather than after 1 h recommended in the guideline.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: granular solid
Details on test material:
- Name of test material: disodium phosphate
- Molecular formula: Na2HPO4
- Physical state: white granules
- Analytical purity: > 97% based on H2O content
- Stability under test conditions: stable indefinitely
- Storage condition of test material: room temperature
- Other: Reference number: 280B 2037S

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.
- Age at study initiation: 2.43 - 2.71 kg
- Weight at study initiation: young adult
- Housing: individually housed in stainless steel rabbit cages and DACB cageboard bedding was used in the litter pans.
- Diet: ad libitum
- Water:ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 68 - 75 ºC
- Humidity (%): 53 - 60 %
- Photoperiod: 12 h dark / 12 h light

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The right eye of the rabbits were used for treatment, the left eyes served as controls.
Amount / concentration applied:
0.1 g per test eye
Duration of treatment / exposure:
The eyes of two of the rabbits remained unwashed and the eyes of the remaining two rabbits were gently washed approximately 20 - 30 sec after treatment.
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
4 animals
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: gently washed with 100 mL of tap water . The rate of application of the tap water was approximately 100 mL/min.
- Time after start of exposure: 20 - 30 sec


SCORING SYSTEM: Draize


TOOL USED TO ASSESS SCORE: after the 24 h examination with a penlight type light, the eyes were examined with the aid of 2 % sodium fluorescein dye.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: both animals tested
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal: both animals tested
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
animal: both animals tested
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal: both animals tested
Time point:
24/48/72 h
Score:
0.66
Max. score:
3
Reversibility:
not fully reversible within: 72 hours
Irritant / corrosive response data:
One h after dosing, mild conjuncitvitis was observed in all eyes. At the 24 h scoring, both of the unwashed eyes had mild conjunctivitis and one of the washed eyes had a slight discharge. Within 48 h of dosing, washed eyes had recovered; both unwashed eyes exhibited slight conjunctivitis which had resolved by the 72 h scoring. Washing the eyes with tap water shortly after exposure decreased both the severity and the duration of the irritation observed.
Other effects:
The mean body weight of the animals was 2.59 ± 0.120 kg on the day prior to dosing. All animals remained healthy throughout the study.

Any other information on results incl. tables

Pretest eye examination

Animal No.

Exam method

Right eye

Left eye

Body weight

(kg)

B5490M

Penlight

N

N

2.57

 

Fluorescein

N

N

B5538M

Penlight

N

N

2.64

 

Fluorescein

N

N

B5492M

Penlight

N

N

2.43

 

Fluorescein

N

N

B5477M

Penlight

N

N

2.71

 

Fluorescein

N

N

Mean

2.59

± SD

± 0.120

B - rabbit

N - normal

M - Male

Individual eye scores:

Animal No.

Cornea

Iris

Conjunctiva

Cornea

Opacity/Area

Iritis

Redness

Chemosis

Discharge

Stain/Area

1 hour

B5490M

0 / 0

0

0

2

3

NA

B5530M

0 / 0

0

0

2

3

NA

B5492M (w)

0 / 0

0

0

1

3

NA

B5477M (w)

0 / 0

0

0

1

3

NA

Primary eye irritation index – unwashed 10.0/110, washed 8.0/110

24 hour

B5490M

0 / 0

0

1

0

3

0 / 0

B5530M

0 / 0

0

1

0

3

0 / 0

B5492M (w)

0 / 0

0

0

0

1

0 / 0

B5477M (w)

0 / 0

0

0

0

0

0 / 0

Primary eye irritation index – unwashed 8.0/110, washed 1.0/110

48 hours

B5490M

0 / 0

0

1

0

2

NA

B5530M

0 / 0

0

1

0

1

NA

B5492M (w)

0 / 0

0

0

0

0

NA

B5477M (w)

0 / 0

0

0

0

0

NA

Primary eye irritation index – unwashed 5.0/110, washed 0.0/110

72 hours

B5490M

0 / 0

0

0

0

0

NA

B5530M

0 / 0

0

0

0

0

NA

B5492M (w)

0 / 0

0

0

0

0

NA

B5477M (w)

0 / 0

0

0

0

0

NA

Primary eye irritation index – unwashed 0.0/110, washed 0.0/110

B - Rabbit

M - Male

(w) - Washed

NA - Not applicable

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of this study the author concludes that the test material is temporarily approximated to be minimally irritating to unwashed eyes and practically non-irritating to washed eyes.
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 when viewed in conjunction with the supporting data.
Disodium hydrogenorthophosphate is not considered to be classified according to Regulation (EC) No. 1272/2008 (EU CLP).