Registration Dossier

Administrative data

Description of key information

The test substance Potassium Sodium Tartrate, tested in two White New Zealand rabbits, applied slightly moistened upon the shaved skin, according to EU test guideline B.4 yielded no irritant response whatsoever, scoring 0 in terms of edema and erythema at all observation periods (24, 48, 72 h). The test substance is concluded to be non-irritating to the skin according to the definitions and procedures of the test guideline.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin 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.
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals 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

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Remarks:
moistened slightly with water for improved contact
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.5 g of test substance per animal (in semiocclusive patch)
Duration of treatment / exposure:
4 hours
Observation period:
3 days, no effect was observed, thereby additional observation was not required.
Number of animals:
2
Details on study design:
TEST SITE
- Area of exposure: Dorsal region , > 6 cm2
- Type of wrap if used: self-adhesive, hypoallergenic, semi-occlusive patch (Mepore (R) or similar). Held with cotton bandage and elastic tubular mesh bandage..

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Gentle rinsing with water.
- Time after start of exposure: 4 h

SCORING SYSTEM: According to tables in EU test Guidelione B.4.
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72
Score:
0
Max. score:
0
Reversibility:
other: No effect
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72
Score:
0
Max. score:
0
Reversibility:
other: No effect
Irritant / corrosive response data:
Erythema and edema score was 0 at 24, 48 and 72 h in the two animals tested. No effects observed upon the skin.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance Potassium Sodium Tartrate, tested in two White New Zealand rabbits, applied slightly moistened upon the shaved skin, according to EU test guideline B.4 yielded no irritant response whatsoever, scoring 0 in terms of edema and erythema at all observation periods (24, 48, 72 h). The test substance is concluded to be non-irritating to the skin according to the definitions and procedures of the test guideline.
Executive summary:

The test substance Potassium Sodium Tartrate, tested in two White New Zealand rabbits, applied slightly moistened upon the shaved skin, according to EU test guideline B.4 yielded no irritant response whatsoever, scoring 0 in terms of edema and erythema at all observation periods (24, 48, 72 h). The test substance is concluded to be non-irritating to the skin according to the definitions and procedures of the test guideline.

Endpoint:
skin irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
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.
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
no
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"
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
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
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.
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

The test substance Potassium Sodium Tartrate, tested in two White New Zealand rabbits, applied slightly moistened upon the shaved

skin, according to EU test guideline B.4 yielded no irritant response whatsoever, scoring 0 in terms of edema and erythema at all

observation periods (24, 48, 72 h). The test substance is concluded to be non-irritating to the skin according to the definitions and

procedures of the test guideline, although continued unprotected exposure or the exposure of sensitive individuals may cause reddening

of the skin and discomfort, as supported by workplace experience in the handling of the substance. .

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.

Justification for classification or non-classification

Both for dermal and occular exposures no or very mild responses where detected, which are far below the classification thresholds for

any of the scores. Thereby the substance is classified as non-irritating although it is recognised that it may cause discomfort and mild

irritation if introduced in the eyes or inhaled or in the event of prolongued and repeated contact with the skin or in contact with damaged

skin.