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Description of key information

Skin Irritation
- REACH_corrosive | rabbit | OECD 404 | #Analogy#
- REACH_not irritating | rabbit | OECD 404 | #Analogy#

Eye Irritation
- REACH_corrosive | Data Waiving - study scientifically not justified

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:
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: - Purity and stability was missing - According to guideline, observations should be made at 30-60 minutes and at 24, 48, and 72 hours after patch removal and not 24 hours, 48 hours and 8 days after start of exposure. -The narrative desciption of the degree and nature of irritation observed is missing
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 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
, see "rationale for reliability"
GLP compliance:
no
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: Assumed no skin irritation present at 72 h reading (erythema = 0).
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: Assumed no skin irritation present at 72 h reading (oedema = 0).
Irritation parameter:
erythema 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: Assumed no skin irritation present at 72 h reading (erythema = 0).
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: Assumed no skin irritation present at 72 h reading (oedema = 0).
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: Assumed no skin irritation present at 72 h reading (erythema = 0).
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: Assumed no skin irritation present at 72 h reading (oedema = 0).
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: Assumed no skin irritation present at 72 h reading (erythema = 0).
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: Assumed no skin irritation present at 72 h reading (oedema = 0).
Interpretation of results:
GHS criteria not met
Conclusions:
Sodium sulphite is not an skin irritant.
According to the criteria specified by Directive 67/548/EEC and subsequent regulations, the test item is not classified as skin irritant.
According to the EC Regulation No. 1272/2008 and subsequent regulations, the test item is not classified as skin irritant.
Endpoint:
skin irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
25 November 1985- 09 December 1985
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was not performed under GLP. OECD 404 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 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
3
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
48 h
Score:
2
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
72 h
Score:
2
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
3
Reversibility:
not reversible
Irritation parameter:
erythema score
Basis:
mean
Time point:
48 h
Score:
3
Reversibility:
not reversible
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Score:
3
Reversibility:
not reversible
Interpretation of results:
Category 1B (corrosive) based on GHS criteria
Conclusions:
Corrosion was observed in all animals after a 4 hour exposure < 14 days. Further testing if corrosion would occur after 3 minutes or 1 hour exposure was not performed, so it can not be differentiated between category 1A or 1B. Therefore, the substance is classified into category 1B.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the substance is classified as skin corrosion, leading to classification as serious eye damage (Category 1)
Endpoint conclusion
Endpoint conclusion:
no study available

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

Skin irritation / corrosion


Based on the corrosivity of sodium polysulfide, which is justified by data on the read-across substance disodium tetra sulfide and based on the classification of disodium sulfide as skin corrosive Cat. 1B according to Annex VI of Regulation (EC) No 1272/2008, the mixture is also considered as corrosive by application of the classification criteria for mixtures as given in the “Guidance on the Application of the CLP Criteria” (Version 5, July 2017).


Based on the given information on the constituents, the mixture is classified as Skin corrosive Category 1B.


Effects on skin irritation/corrosion: corrosive


Eye irritation


With the conclusion that the mixture is classified as Skin corrosive Category 1B, serious damage to eyes is implicit and no further evaluation of this endpoint is required in accordance with column 2 of REACH Annex VII.


Effects on eye irritation: corrosive