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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Remarks:
The test was performed in an EN-ISO 17025 accredited laboratory for the purpose of waste characterisation under Spanish Ministerial Order 13/10/1989 and Royal Decree 952/97. Although the test was not performed by a GLP accredited laboratory the official EU / OECDE test method was followed and all reporting a quality criteria in the test guideline were met.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report Date:
2010

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Test material form:
solid: crystalline
Specific details on test material used for the study:
Substance referred to as Potassium Sodium Tartrate Tetrahydrate resulting from an accidental spill during loading. Purity of tested sample prior to becoming waste: >98%. No apparent soiling of foreign materials appreciable in sample received at test laboratory. Sample received referenced labelled "Sal de Rochelle polvo 280410"

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories (France)
- Weight at study initiation: > 1750
- Housing: Individual stainless steel cages, suitably identified.
- Diet: ad libutum. Granulated maintenance feed. Supplier: Harlan Iberica. S.L.
- Water : ad libitum (water from municipal supply city of Madrid)
- Acclimation period: 20 days. No anomalies observed after end of acclimation.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 °C ± 3
- Humidity (%): 30 - 70 % relative humidity
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
0.1 g of test substance (tetrahydrate salt) applied in the conjunctival sac of the right eye of each animal exposed.
Duration of treatment / exposure:
1h
Observation period (in vivo):
72 h. Observations at 1, 24, 48 and 72 h.
Number of animals or in vitro replicates:
2
Details on study design:
Scoring according to tables in EU test method B.4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
72 h
Score:
ca. 0
Max. score:
0
Reversibility:
other: no data 8no effect)
Irritation parameter:
iris score
Basis:
mean
Time point:
72 h
Score:
ca. 0
Max. score:
0
Reversibility:
other: no effect
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
72 h
Score:
ca. 0
Max. score:
0
Reversibility:
other: no effect
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
72 h
Score:
ca. 0
Max. score:
0
Reversibility:
other: no effect
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24 h
Score:
ca. 0
Max. score:
0
Reversibility:
fully reversible within: 48h
Remarks:
Slight edema seen in the nictitating membrane at 1st hour. Completely reversed at 48 h.
Irritant / corrosive response data:
None of the scores approximate the values required for the classification of the substance as an eye irritant according to EU classification and labelling requirements. Mild reversible irritation(1 in chemosis score) was appreciated in one of the test animals after 1 h exposure, which reversed completely after 48 h.

Applicant's summary and conclusion

Interpretation of results:
other: not irritting
Conclusions:
The substance is not classified as irritating although it may cause fully reversible slight edema of the conjunctiva and will cause discomfort of exposed individuals. Workplace experience supports this conclusion.
Executive summary:

Potassium sodium tartrate tetrahydrate (0.1 g) applied into the conjuntival sac of the right eye of two White New Zealand rabbits for 1 h

according to EU test guideline B.5. revealed that the substance produced a mild conjuntival irritation in 1 of the two animals, which was

fully reversible after 48h. Corneal, iris and conjunctival reddening scores were all cero at all observation periods and overall tje substance

is not classified as irritating although it may cause fully reversible slight edema of the conjunctiva and will cause discomfort of exposed

individuals. Workplace experience supports this conclusion.