Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from 1982-03-09 to 1982-03-19
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions. Methodology used is similar to OECD 405 and OPPTS 870.2400 guidelines. No details on experimental conditions. Only raw data reported.
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
. Reliability scoring based on 1981 OECD guideline for test n°405
Deviations:
no
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material: Sodium hypophosphite, sodium hypophosphite monohydrate
- Analytical purity: 86 % (expressed in anhydrous form, NaH2PO2)
- Impurities: Phosphorous acid Anh. (NaH2PO2) 0.44 %, iron (Fe) 2.3 ppm, Heavy metals (Pb) 2 ppm, Citric acid 0.22 %
- Purity test date: 1981-11-05
- Lot/batch No.: 106
- Other: pH= 4.7
No more data available

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
IN-LIFE DATES: From: 1982-03-09 To: 1982-03-16 (or 1982-03-19 for one animal)
No more data available

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: each animal served as its own control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg
Duration of treatment / exposure:
Single exposure
Observation period (in vivo):
Ten days which was the duration needed to clear all ocular effects.
Number of animals or in vitro replicates:
9 rabbits ( 6 animals with eyes not washed after instillation of the test item and 3 animals with eyes washed after instillation of the test item).
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: yes, for 3 animals
- Time after start of exposure: unknown

SCORING SYSTEM: cf free text of materials and methods. Grading scale used is equivalent to the one used in OECD 405.
No more data available

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
: Eyes not rinsed
Basis:
mean
Remarks:
: 6 animals
Time point:
other: mean of the 24, 48 and 72 hours readings
Score:
0
Max. score:
4
Irritation parameter:
iris score
Remarks:
: Eyes not rinsed
Basis:
mean
Remarks:
: 6 animals
Time point:
other: mean of the 24, 48 and 72 hours readings
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Remarks:
: (Redness) Eyes not rinsed
Basis:
mean
Remarks:
: 6 animals
Time point:
other: mean of the 24, 48 and 72 hours readings
Score:
0.89
Max. score:
3
Reversibility:
fully reversible within: 10 days
Irritation parameter:
chemosis score
Remarks:
: Eyes not rinsed
Basis:
mean
Remarks:
: 6 animals
Time point:
other: mean of the 24, 48 and 72 hours readings
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 3 days
Irritation parameter:
cornea opacity score
Remarks:
: Eyes rinsed
Basis:
mean
Remarks:
: 3 animals
Time point:
other: mean of the 24, 48 and 72 hours readings
Score:
0
Max. score:
4
Irritation parameter:
iris score
Remarks:
: Eyes rinsed
Basis:
mean
Remarks:
: 3 animals
Time point:
other: mean of the 24, 48 and 72 hours readings
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Remarks:
: (redness) Eyes rinsed
Basis:
mean
Remarks:
: 3 animals
Time point:
other: mean of the 24, 48 and 72 hours readings
Score:
0.66
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Remarks:
: Eyes rinsed
Basis:
mean
Remarks:
: 3 animals
Time point:
other: mean of the 24, 48 and 72 hours readings
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 4 days
Irritant / corrosive response data:
Without rinsing, a slight (grade1) and fully reversible (within 10 days) redness of the conjunctivae was observed in all rabbits. A slight chemosis
(grade 1) was present in 4 out of 6 rabbits but the reaction cleared within 3 days.
The washing procedure did not modify the ocular reactions. All animals showed a slight (grade 1) and transient redness of the conjunctivae. Chemosis was observed in 1 out 3 animals but the reaction cleared within 4 days.
No lesions of cornea or iris were reported whatever the procedure od treatment. (See Table 1 for complete raw data)

Any other information on results incl. tables

Table 1: Synthesis of the raw results

Scores per animal

Observation

Pre-dose

Day 1

Day 2

Day 3

Day 4

Day 7

Day 10

Eyes not rinsed

(6 animals)

Cornea opacity (0-4)

0/0/0/0/0/0

0/0/0/0/0/0

0/0/0/0/0/0

0/0/0/0/0/0

0/0/0/0/0/0

0/0/0/0/0/0

nd/0

Cornea area (0-4)

0/0/0/0/0/0

0/0/0/0/0/0

0/0/0/0/0/0

0/0/0/0/0/0

0/0/0/0/0/0

0/0/0/0/0/0

nd/0

Iris

(0-2)

0/0/0/0/0/0

0/0/0/0/0/0

0/0/0/0/0/0

0/0/0/0/0/0

0/0/0/0/0/0

0/0/0/0/0/0

nd/0

Conjonctivae redness (0-3)

0/0/0/0/0/0

1/1/1/1/1/1

1/1/1/1/1/1

1/0/1/1/1/0

1/0/0/1/1/1

0/0/0/0/0/1

nd/0

Conjonctivae chemosis (0-4)

0/0/0/0/0/0

0/0/1/1/1/0

0/0/1/1/0/1

0/0/0/0/0/0

0/0/0/0/0/0

0/0/0/0/0/0

nd/0

Conjonctivae discharge (0-3)

0/0/0/0/0/0

1/1/1/1/1/1

1/1/1/1/0/0

0/1/1/1/0/0

0/1/1/1/1/0

0/0/0/0/0/0

nd/0

Total

 

0/0/0/0/0/0

4/4/6/6/6/4

4/4/6/6/2/4

2/2/4/4/2/0

2/2/2/4/2

0/0/0/0/0/2

 

Eyes rinsed
(3 animals)

Cornea opacity (0-4)

0/0/0

0/0/0

0/0/0

0/0/0

0/0/0

0/0/0

nd

Cornea area (0-4)

0/0/0

0/0/0

0/0/0

0/0/0

0/0/0

0/0/0

nd

Iris

(0-2)

0/0/0

0/0/0

0/0/0

0/0/0

0/0/0

0/0/0

nd

Conjonctivae redness (0-3)

0/0/0

1/1/1

0/1/1

0/1/0

0/1/0

0/0/0

nd

Conjonctivae chemosis (0-4)

0/0/0

0/0/1

0/0/1

0/0/1

0/0/0

0/0/0

nd

Conjonctivae discharge (0-3)

0/0/0

2/1/1

0/0/1

0/0/1

0/0/1

0/0/0

nd

Total

 

0/0/0

6/4/6

0/2/6

0/2/4

0/2/2

0/0/0

 

To obtain subtotal for the cornea multiply the product of the opacity and area scores by 5. For the iris subtotal multiply the score by 5 and for conjunctivae multiply the sum of the scores (redness, chemosis and discharge) by 2.

Total: sum of all subtotals per animal

Table 2: Irritant/corrosive response data of each animal except washed animals according to OPPTS and OECD guidelines scoring system

Score at time point/ Reversibility 

Cornea
Max. score: 4

Iris
Max. score: 2

Conjunctivae Redness
Max. score: 3

Conjunctivae

Chemosis
Max. score: 4

24 h

0/0/0/0/0/0

0/0/0/0/0/0

1/1/1/1/1/1

0/0/1/1/1/0

48 h

0/0/0/0/0/0

0/0/0/0/0/0

1/1/1/1/1/1

0/0/1/1/0/1

72 h

0/0/0/0/0/0

0/0/0/0/0/0

1/0/1/1/1/0

0/0/0/0/0/0

Average 24h, 48h, 72h

0

0

0.89

0.33

Reversibility*

-

-

c.(10 days)

c.

* c.=completely reversible

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: CLP (Reg. 1272/2008/EC)
Conclusions:
Under the experimental conditions of this study and according to the criterai laid down in CLP (Reg 1272/2008/EC), the test item Sodium
hypophosphite is considered as non-irritant to the eyes.
Executive summary:

The potential of Sodium hypophosphite to induce eye irritation was assessed in 9 rabbits according to methods similar to OPPTS 870.2400 and OECD 405 guidelines. There were no information in the report about GLP compliance.

A single dose of 100 mg of the test item was instilled into one eye, the other eye was not treated and served as control. For 6 rabbits, the eyes were not rinsed after administration of the test item while a washing procedure was applied for 3 other animals .Ocular reactions were observed 24, 48 and 72 hours after the administration and then daily until reversibility of the ocular reactions. The values of the scores for chemosis, redness of the conjunctiva, iris lesions and corneal opacity were noted for each animal.

Mean scores calculated over 24, 48 and 72 hours for the 6 animals without rinsing were 0.33 for chemosis, 0.89 for redness of the conjunctiva, 0 for iris lesions and 0 for corneal opacity. Redness and chemosis were fully reversible within 10 and 3 days respectively.

Washing procedure did not change the ocular reactions.

Under these experimental conditions,Sodium hypophosphite was considered non- irritant when administered by ocular route to rabbits.