Disodium tartrate

Endpoint summary

Description of key information

Skin irritation (EU Method B.4): not irritating

RA from source substance potassium sodium tartarate tetrahydrate (CAS 6381-59-5)

Eye irritation ( EU Method B.5): not irritating

RA from source substance potassium sodium tartarate tetrahydrate (CAS 6381 -59-5)

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Reference 1

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 / OECD test method was followed and all reporting a quality criteria in the test guideline were met.

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal 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.

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system 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

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 Guideline B.4.

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: No effect

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

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.

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.

Interpretation of results:

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

Conclusions:

CLP: not classified

Reference 2

Endpoint:

skin irritation: in vivo

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

refer to analogue justification provided in IUCLID section 13

Reason / purpose for cross-reference:

read-across source

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: No effect

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: No effect

Interpretation of results:

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

Conclusions:

CLP: not classified
In a study similar to EU Method B.4 with the source substance no skin irritation potential was observed. As explained in the analogue justification, this result is considered to be valid also for the target substance.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Reference 1

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.

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.

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

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.

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no effect

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: no effect

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

other: no effect

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no effect

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.

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.

Interpretation of results:

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

Conclusions:

CLP: not classified

Reference 2

Endpoint:

eye irritation: in vivo

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

refer to analogue justification provided in IUCLID section 13

Reason / purpose for cross-reference:

read-across source

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no effect

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: no effect

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

other: no effect

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no effect

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.

Interpretation of results:

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

Conclusions:

CLP: not classified
In a study similar to EU Method B.5 with the source substance no eye irritation potential was observed. As explained in the analogue justification, this result is considered to be valid also for the target substance.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Irritation/Corrosion

 

Justification for read-across

There are no data on Irritation/Corrosion available for disodium tartrate (CAS 868 -18 -8). To fulfil the standard data requirements defined in Regulation (EC) No. 1907/2006, Annex VII, 8.1 and 8.2., read-across from an appropriate substance is conducted in accordance with Regulation (EC) No. 1907/2006, Annex XI.

According to Article 13 (1) of Regulation (EC) No 1907/2006, "information on intrinsic properties of substances may be generated by means other than tests, provided that the conditions set out in Annex XI are met”. In particular for human toxicity, information shall be generated whenever possible by means other than vertebrate animal tests, which includes the use of information from structurally related substances (grouping or read-across) “to avoid the need to test every substance for every endpoint”.

 

For each specific endpoint the source substance(s) structurally closest to the target substance is/are chosen for read across, with regard to the requirements of adequacy and reliability of the available data. Structural similarities and similarities in properties and/or activities of the source and target substances are the basis of read-across. A detailed justification for the analogue read- across approach is provided in the technical dossier (see IUCLID Section 13).

 

As no experimental/measured data are available on Skin and Eye Irritation/Corrosion of disodium tartrate (CAS 868 -18 -8), read-across to reliable data on the analogue substance potassium sodium tartrate tetrahydrate (CAS 6381-59-5) was conducted.

 

Skin Irritation

The skin irritation properties of the test substance were tested in a study in rabbits according to EU Method B.4 (reference 7.3.1 -1). They were exposed to 0.5 g of the unchanged test substance for 4 hours leading to an erythema and edema score of 0. Therefore, potassium sodium tartrate is not regarded as skin irritant.

 

Eye irritation

The eye irritation properties of the test substance were tested in a study in rabbits according to EU Method B.5 (reference 7.3.1 -2). They were exposed to 0.1 g of the unchanged test substance for 1 h resulting in a cornea opacity/ iris/ conjunctivae score of 0 and an chemosis score of 0 in one animal and in the other a score of 1, which was fully reversible within 48 h. Based on the obtained results, potassium sodium tartrate is not eye irritating.

Justification for classification or non-classification

Based on the analogue read-across approach, the available data on irritation do not meet the classification criteria according to Regulation (EC) 1272/2008, and are therefore conclusive but not sufficient for classification.