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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
November 1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to a protocol which was equivalent to current guideline but not compliant with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: HLE protocol number P520/22/6/-/553/Rev.1
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
EDTMP-xCaxNa
IUPAC Name:
EDTMP-xCaxNa
Constituent 2
Chemical structure
Reference substance name:
[ethylenebis[nitrilobis(methylene)]]tetrakisphosphonic acid, calcium sodium salt
EC Number:
287-370-9
EC Name:
[ethylenebis[nitrilobis(methylene)]]tetrakisphosphonic acid, calcium sodium salt
Cas Number:
85480-89-3
Molecular formula:
C6H20-2x-yN2O12P4.xCa.yNa
IUPAC Name:
[ethylenebis[nitrilobis(methylene)]]tetrakisphosphonic acid, calcium sodium salt
Details on test material:
- Name of test material (as cited in study report):
- Physical state: white powder
- Storage condition of test material: room temperature
- -EDTMP-xCa.xNa 26%, NaCl 12%, and water 62%. Phosphonate content ca. 92%.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: > 2kg
- Housing: Caged individually in grid floor cages in a single room with fan controlled air circulation.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: minimum of 3 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): lower limit of 14
- Humidity (%): not controlled
- Photoperiod (hrs dark / hrs light): natural lighting conditions supplemented with fluorescent lighting during 8.45-17.00

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
Observation period (in vivo):
The eyes were examined for signs of irritation 1, 2, 3, 4 and 7 days after treatment.
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: The irritation was scored according to Draize (1959).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24/48/72h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24/48/72h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24/48/72h
Score:
0.6
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24/48/72h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible

Any other information on results incl. tables

Table 1: Irritant/corrosive response data for each animal up to 72 hours

Score at time point / Reversibility

Cornea

Iris

Conjunctivae

Chemosis

24 h

0/0/0/0/0/0 

 0/0/0/0/0/1

 1/1/1/1/1/2

 1/0/1/1/1/2

48 h

    0/0/0/0/0/0 

 0/0/0/0/0/0 

 1/0/0/0/0/1

 0/0/0/0/0/0

72 h

    0/0/0/0/0/0 

0/0/0/0/0/0  

 1/0/0/0/0/1

 0/0/0/0/0/0  

Average 24h, 48h, 72h

 0

 0.1

 0.6

 0.3

Reversibility*)

 *) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

 

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: not specified
Conclusions:
The test material was found mildly irritating in a study conducted according to a protocol which was equivalent to guideline, but not compliant with GLP.

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