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Endpoint summary

Description of key information

Oral route:
- REACH_LD50 = 2610 mg/kg bw | rat (male/female) | OECD 401 | #Analogy#
- REACH_LD50 > 2000 mg/kg bw | rat (female) | OECD 425 | #Analogy#
- REACH_LD50 = 128-130 mg/kg bw | rat (male/female) | OECD 401 | #Analogy#
- REACH_LD50 = 86 mg/kg bw | rat (male/female) | OECD 401 | #Analogy#
- REACH_LD50 = 254 mg/kg bw | rat (male/female) | OECD 401 | #Analogy#
- REACH_LD50 = 1122 mg/kg bw | rat (male/female) | OECD 401 | #Analogy#
Dermal route:
- Data waiving (Calculation based on analytical results of ingredients).

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Reference 1

Endpoint:

acute toxicity: oral

Type of information:

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

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Comparable to guideline study reliable with restrictions Minor deviations with no effect on the results: - The purity and stability were missing. - The number of animals showing signs of toxicity was missing. -The method for LD50 calculation was not stated.

Justification for type of information:

Read-across Hypothesis
The reaction mass is composed of the following substances: sodium sulfite, sodium thiosulfate, sodium polysulfide and disodium sulfide, with residual amounts of sodium sulfate (see detailed description in section 1.2).
The read-across hypothesis is that the reaction mass can be considered as a mixture of the different salts and all the members of the reaction mass are various salts with sodium as cation and S-compounds as anion.
The main assumption is that the cationic species do not contribute significantly to any differences in solubility or toxicity and thus will not influence the toxicological endpoints under consideration. In dilute aqueous conditions the salts will be fully dissociated. Hence the properties as expressed in aqueous media for the mixture of the given salts can be directly read across with suitable mass correction to the individual components of the mixture which are as well dissociated.
As some toxicological data and classification of the individual constituents as well as the quantitative composition are known, data are evaluated in a weight-of-evidence approach for the mixture of those constituents.

Category justification
The salts of the reaction mass all have high water solubility. Their behavior in water and biological systems is dominated by their ionization. Measured data was available for health endpoints for sodium sulfite, sodium polysulfide, calcium thiosulfate, disodium tetra sulfide, disodium disulfide, disodium sulfide, and ammonium thiosulfate. Thus, data is read across to the mixture of all salts in the reaction mass.

Reason / purpose for cross-reference:

read-across source

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

, see "Rationale for reliability"

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 2 610 mg/kg bw

Based on:

test mat.

Interpretation of results:

GHS criteria not met

Conclusions:

According to the criteria specified by Directive 67/548/EEC and subsequent regulations, the test item is not classified as acute toxic via the oral route.
According to the EC Regulation No. 1272/2008 and subsequent regulations, the test item is not classified as acute toxic via the oral route.

Reference 2

Endpoint:

acute toxicity: oral

Type of information:

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

Adequacy of study:

weight of evidence

Study period:

2009-07-13 to 2009-07-31

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Guideline study reliable without restrictions Minor deviations without an effect on the results: - According to the guideline, the animals are observed at least once during the first 30 minutes after dosing, periodically during the first 24 hours (with special attention given during the first 4 hours), and daily thereafter, for a total of 14 days. In this study the animals were observed during the first several hours post-dosing and at least once daily thereafter for 14 days after dosing. -According to the guideline, the rational for the starting dose should be stated. This was missing from the study report.

Justification for type of information:

Read-across Hypothesis
The reaction mass is composed of the following substances: sodium sulfite, sodium thiosulfate, sodium polysulfide and disodium sulfide, with residual amounts of sodium sulfate (see detailed description in section 1.2).
The read-across hypothesis is that the reaction mass can be considered as a mixture of the different salts and all the members of the reaction mass are various salts with sodium as cation and S-compounds as anion.
The main assumption is that the cationic species do not contribute significantly to any differences in solubility or toxicity and thus will not influence the toxicological endpoints under consideration. In dilute aqueous conditions the salts will be fully dissociated. Hence the properties as expressed in aqueous media for the mixture of the given salts can be directly read across with suitable mass correction to the individual components of the mixture which are as well dissociated.
As some toxicological data and classification of the individual constituents as well as the quantitative composition are known, data are evaluated in a weight-of-evidence approach for the mixture of those constituents.

Category justification
The salts of the reaction mass all have high water solubility. Their behavior in water and biological systems is dominated by their ionization. Measured data was available for health endpoints for sodium sulfite, sodium polysulfide, calcium thiosulfate, disodium tetra sulfide, disodium disulfide, disodium sulfide, and ammonium thiosulfate. Thus, data is read across to the mixture of all salts in the reaction mass.

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)

Deviations:

yes

Remarks:

, see "Rationale for reliability"

GLP compliance:

yes

Test type:

up-and-down procedure

Limit test:

yes

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of this study, the acute oral LD50 of Aqueous solution of calcium thiosulfate (CaTS) is greater than 2000 mg/kg bw in female rats. According to the criteria specified by Directive 67/548/EEC and subsequent regulations, the test item is not classified as acute toxic via the oral route. According to the EC Regulation No. 1272/2008 and subsequent regulations, the test item is not classified as acute toxic via the oral route.

Reference 3

Endpoint:

acute toxicity: oral

Type of information:

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

Adequacy of study:

weight of evidence

Study period:

20 September 1985 - 01 November 1985

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was not performed under GLP. OECD 401 was followed.

Justification for type of information:

Read-across Hypothesis
The reaction mass is composed of the following substances: sodium sulfite, sodium thiosulfate, sodium polysulfide and disodium sulfide, with residual amounts of sodium sulfate (see detailed description in section 1.2).
The read-across hypothesis is that the reaction mass can be considered as a mixture of the different salts and all the members of the reaction mass are various salts with sodium as cation and S-compounds as anion.
The main assumption is that the cationic species do not contribute significantly to any differences in solubility or toxicity and thus will not influence the toxicological endpoints under consideration. In dilute aqueous conditions the salts will be fully dissociated. Hence the properties as expressed in aqueous media for the mixture of the given salts can be directly read across with suitable mass correction to the individual components of the mixture which are as well dissociated.
As some toxicological data and classification of the individual constituents as well as the quantitative composition are known, data are evaluated in a weight-of-evidence approach for the mixture of those constituents.

Category justification
The salts of the reaction mass all have high water solubility. Their behavior in water and biological systems is dominated by their ionization. Measured data was available for health endpoints for sodium sulfite, sodium polysulfide, calcium thiosulfate, disodium tetra sulfide, disodium disulfide, disodium sulfide, and ammonium thiosulfate. Thus, data is read across to the mixture of all salts in the reaction mass.

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Preliminary study:

Not applicable

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

130 mg/kg bw

95% CL:

81 - 180

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

128 mg/kg bw

95% CL:

66 - 324

Interpretation of results:

Category 3 based on GHS criteria

Conclusions:

The LD50 for males is 130 mg/kg bw (95% CL 81 -180) and for females 128 mg/kg bw (95% CL 66 -324).

Executive summary:

The acute oral toxicity of disodium tetrasulphide was investigated in an OECD 401 study using male and female rats in test groups containing 5 animals per sex per group. Doses: males: 100, 147, 215 mg/kg bw, females: 46.4, 100, 215 mg/kg bw.

The clinical signs observed in the animals that died were ataxia, strong klonic convulsions, reduction in muscular tone, absence of reflexes, labored breathing, difficulty breathing. The signs occur 1 minute after dosing and last until death.

Animals that survived, exept for one male showing ataxia, did not show any clinical signs. Animals died bewteen 3-12 minutes after application.

Autopsy revealed no abnormalities. The LD50 for males is 130 mg/kg bw (95% CL 81 -180) and for females 128 mg/kg bw (95% CL 66 -324).

Reference 4

Endpoint:

acute toxicity: oral

Type of information:

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

Adequacy of study:

weight of evidence

Study period:

13 November 1989 - 29 November 1989

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study was performed according to OECD 401 and GLP.

Justification for type of information:

Read-across Hypothesis
The reaction mass is composed of the following substances: sodium sulfite, sodium thiosulfate, sodium polysulfide and disodium sulfide, with residual amounts of sodium sulfate (see detailed description in section 1.2).
The read-across hypothesis is that the reaction mass can be considered as a mixture of the different salts and all the members of the reaction mass are various salts with sodium as cation and S-compounds as anion.
The main assumption is that the cationic species do not contribute significantly to any differences in solubility or toxicity and thus will not influence the toxicological endpoints under consideration. In dilute aqueous conditions the salts will be fully dissociated. Hence the properties as expressed in aqueous media for the mixture of the given salts can be directly read across with suitable mass correction to the individual components of the mixture which are as well dissociated.
As some toxicological data and classification of the individual constituents as well as the quantitative composition are known, data are evaluated in a weight-of-evidence approach for the mixture of those constituents.

Category justification
The salts of the reaction mass all have high water solubility. Their behavior in water and biological systems is dominated by their ionization. Measured data was available for health endpoints for sodium sulfite, sodium polysulfide, calcium thiosulfate, disodium tetra sulfide, disodium disulfide, disodium sulfide, and ammonium thiosulfate. Thus, data is read across to the mixture of all salts in the reaction mass.

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

85.8 mg/kg bw

95% CL:

73.8 - 99.6

Interpretation of results:

Category 3 based on GHS criteria

Conclusions:

The LD50 for males is 82.5 (95% CL 60.8 - 112) mg/kg bw and for females 92.8 (95% CL 68.8 - 127) mg/kg bw. For male and female rats the LD50 is 85.8 (95% CL 73.8 - 99.6) mg/kg bw.

Reference 5

Endpoint:

acute toxicity: oral

Type of information:

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

Adequacy of study:

weight of evidence

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Comparable to guideline without restrictions. Only minor deviations with no effect on the study: - The stability of the test substance was not stated. - 20 ml of 5000 mg/kg was administered, while a volume of 10 ml was administered of all other dose levels. - The findings for 5000 mg/kg were not used for determining the LD50 estimate. - According to the guideline, changes in weight should be calculated and recorded when survival exceeded one day. This is missing in this report. However body weight data are available. - According to the guideline, the number of animals showing toxic signs other than mortality should be stated. This was missing in the report.

Justification for type of information:

Read-across Hypothesis
The reaction mass is composed of the following substances: sodium sulfite, sodium thiosulfate, sodium polysulfide and disodium sulfide, with residual amounts of sodium sulfate (see detailed description in section 1.2).
The read-across hypothesis is that the reaction mass can be considered as a mixture of the different salts and all the members of the reaction mass are various salts with sodium as cation and S-compounds as anion.
The main assumption is that the cationic species do not contribute significantly to any differences in solubility or toxicity and thus will not influence the toxicological endpoints under consideration. In dilute aqueous conditions the salts will be fully dissociated. Hence the properties as expressed in aqueous media for the mixture of the given salts can be directly read across with suitable mass correction to the individual components of the mixture which are as well dissociated.
As some toxicological data and classification of the individual constituents as well as the quantitative composition are known, data are evaluated in a weight-of-evidence approach for the mixture of those constituents.

Category justification
The salts of the reaction mass all have high water solubility. Their behavior in water and biological systems is dominated by their ionization. Measured data was available for health endpoints for sodium sulfite, sodium polysulfide, calcium thiosulfate, disodium tetra sulfide, disodium disulfide, disodium sulfide, and ammonium thiosulfate. Thus, data is read across to the mixture of all salts in the reaction mass.

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

, see "Rationale for reliability"

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

254 mg/kg bw

Based on:

test mat.

Remarks:

Na2S, 60 %

95% CL:

162 - 483

Remarks on result:

other: The results indicate that the LD50 (male and female) calculated for the most concentrated commercial form Na2S, 62 %, would be 246 mg/kg bw.

Interpretation of results:

Category 3 based on GHS criteria

Conclusions:

The resulting LD50 value from this study for sodium sulfide 60 % is as follows: LD50 calculated = 253.8 mg for males and females.
According to the criteria specified by Directive 67/548/EC and subsequent regulations the test item is harmful if swallowed (Xn, R22) and requires classification. According to the criteria specified by Regulation (EC) No 1272/2008 and subsequent regulations the test item is toxic if swallowed (toxic category III according to GHS) and requires classification.

Reference 6

Endpoint:

acute toxicity: oral

Type of information:

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

Adequacy of study:

weight of evidence

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Comparable to guideline OECD 401 (1987) without restrictions. Only minor deviations with no effect on the study: - The time when signs of toxicity appeared and disappear were not given. - The dose of 2000 mg/kg was already tested in a preliminary study and all animals (2 animals) died after approx. 38 minutes. The same dose was tested again in the main study with 5 animals.

Justification for type of information:

Read-across Hypothesis
The reaction mass is composed of the following substances: sodium sulfite, sodium thiosulfate, sodium polysulfide and disodium sulfide, with residual amounts of sodium sulfate (see detailed description in section 1.2).
The read-across hypothesis is that the reaction mass can be considered as a mixture of the different salts and all the members of the reaction mass are various salts with sodium as cation and S-compounds as anion.
The main assumption is that the cationic species do not contribute significantly to any differences in solubility or toxicity and thus will not influence the toxicological endpoints under consideration. In dilute aqueous conditions the salts will be fully dissociated. Hence the properties as expressed in aqueous media for the mixture of the given salts can be directly read across with suitable mass correction to the individual components of the mixture which are as well dissociated.
As some toxicological data and classification of the individual constituents as well as the quantitative composition are known, data are evaluated in a weight-of-evidence approach for the mixture of those constituents.

Category justification
The salts of the reaction mass all have high water solubility. Their behavior in water and biological systems is dominated by their ionization. Measured data was available for health endpoints for sodium sulfite, sodium polysulfide, calcium thiosulfate, disodium tetra sulfide, disodium disulfide, disodium sulfide, and ammonium thiosulfate. Thus, data is read across to the mixture of all salts in the reaction mass.

Reason / purpose for cross-reference:

read-across source

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

, see "Rationale for reliability"

Qualifier:

according to guideline

Guideline:

EPA OTS 798.1175 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

1 122 mg/kg bw

Based on:

test mat.

Remarks:

Na2S

95% CL:

939 - 1 342

Remarks on result:

other: The results indicate that the LD50 calculated for the most concentrated commercial form Na2S, 62 %, would be 1810 mg/kg bw .

Interpretation of results:

Toxicity Category IV

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute median lethal oral dose (LD50) of sodium sulfide (anhydrous) for male and female rats derived in this study was calculated to be 1122 mg/kg bw.
According to the criteria specified by Directive 67/548/EC, Regulation (EC) No 1272/2008 and subsequent regulations the test item is harmful and requires classification (Xn; R22 according to 67/548/EEC and toxic category IV according to GHS). The calculated LD50 value of 1810 mg/kg bw for the most concentrated commercial form Na2S, 62 %, would lead to the same classifications.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

228.8 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Dose descriptor:

LD50

Value:

881.9 mg/kg bw

Quality of whole database:

Estimation by calculation, further information see justification.

Justification for classification or non-classification

Acute toxicity: via oral route

The ATE of the mixture is calculated based on the given LD₅₀ values of the constituents or of relevant read-across substances (see endpoint study records). The applied calculation method is described in the “Guidance on the Application of the CLP Criteria” (Version 5, July 2017). Ingredients that were not acutely toxic were not considered for the calculation. In cases where different values were available for one constituent, the lower value was considered (86 mg/kg for disodium disulfide and 254 mg/kg for disodium sulfide).

The resulting ATE for the mixture and, thus, for the reaction mass at hands is 229 mg/kg (Category 3).

Justification for selection of acute toxicity – oral endpoint
Calculation based on analytical result of ingredients.

 

Acute toxicity: via dermal route

No data are submitted for this endpoint as this is not a data requirement for the tonnage band 1-10 t/year. However, as one of the constituents (disodium sulfide) is classified for acute dermal toxicity according to Annex VI of Regulation (EC) No 1272/2008, an ATE for the reaction mass needs to be calculated. No reliable study was available for disodium sulfide, therefore the ATE was converted from the classification (Cat. 3: ATE 300). Additionally, a dermal LD₅₀ value for another constituent (disodium disulfide) was retrieved from the respective REACH dossier, which needs to be considered as well (LD₅₀ = 590 mg/kg, http://echa.europa.eu/registration-dossier/-/registered-dossier/14431/2/1).

The resulting ATE for the mixture and, thus, for the reaction mass at hands is 882 mg/kg (Category 3).

Justification for selection of acute toxicity – dermal endpoint
Calculation based on analytical result of ingredients