Disodium tartrate

Eye irritation

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:

other: see 'Remark'

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

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

no

Remarks:

The test was performed in an EN-ISO 17025 accredited laboratory (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/OECD test method was followed.

Test material

Test material information

Constituent 1

Reference substance name:

potassium sodium tartrate tetrahydrate

EC Number:

613-385-0

Cas Number:

6381-59-5

Molecular formula:

C4H12KNaO10

IUPAC Name:

potassium sodium tartrate tetrahydrate

Constituent 2

Reference substance name:

Potassium sodium tartrate

EC Number:

206-156-8

EC Name:

Potassium sodium tartrate

Cas Number:

304-59-6

Molecular formula:

C4H6O6.K.Na

IUPAC Name:

potassium sodium tartarate

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 g
- Housing: Individual stainless steel cages
- 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 ± 3
- Humidity (%): 30 - 70% relative humidity
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

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:

1 h

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

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no effect

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: no effect

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

other: no effect

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no effect

Results 5

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Remarks on result:

other: 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.

Any other information on results incl. tables

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 zero at all observation periods and 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.

Applicant's summary and conclusion

Interpretation of results:

other: CLP/ EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008

Conclusions:

CLP: not classified