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Diss Factsheets

Administrative data

Description of key information

Read across from potassium sulfite and sodium sulfite as well as ammonium-, sodium- and potassium hydrogensulfite provided five reliable in-vivo skin irritation studies.  
The tests on skin irritation show a negative response, thus, based on read-across (see `discussion`), sodium dithionite does not require classification as skin irritant.
The results of two reliable eye irritation studies for the test item sodium dithionite indicate eye irritation properties. According to the criteria specified by Directive 67/548/EEC and subsequent regulations, the test item should be classified as eye irritant. According to the EC Regulation No. 1272/2008 and subsequent regulations, the test item should be classified as eye irritant Category 2.

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 based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
The stability was not given. - According to the guideline the animals should be examined for signs of erythema and oedema and the responses scored at 30 -60 minutes, and then at 24, 48, and 72 hours after patch removal. In this study the examinations took place at other times (4, 24, and 48 hours) From our point of view, this does not have an effect on the classification of the test substance.
Justification for type of information:
see attachment “Read-across concept – Human Health/Environment - Category approach for Inorganic sulfites/thiosulfates/dithionite" in section 13.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1981-05-12
Deviations:
yes
Remarks:
skin examinations took only place at 4, 24, and 48 hours
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
no data
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL of the compounds
Duration of treatment / exposure:
4 hours
Observation period:
4, 24 and 48 hours
Number of animals:
6 or more animals
Details on study design:
TEST SITE
- Area of exposure/Type of wrap if used: application of the compound was made under one-inch square gauze patches to clipped intact skin sites on the backs of albino rabbits each. Thea animals were immobilized in restrainers and their trunks were wrapped in a nonabsorbant binder for the exposure period.

SCORING SYSTEM: according to Draize scale
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #1
Time point:
24/48 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #1
Time point:
24/48 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #2
Time point:
24/48 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #2
Time point:
24/48 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #3
Time point:
24/48 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #3
Time point:
24/48 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #4
Time point:
24/48 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #4
Time point:
24/48 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #5
Time point:
24/48 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #5
Time point:
24/48 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #6
Time point:
24/48 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #6
Time point:
24/48 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #1
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #1
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #2
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #2
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #3
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #3
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #4
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #4
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #5
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #5
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #6
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #6
Time point:
72 h
Remarks on result:
not measured/tested
Irritant / corrosive response data:
Sodium metabisulfite solution elicited no response in albino rabbits.
Interpretation of results:
GHS criteria not met
Conclusions:
Sodium metabisulfite solution elicited no response in albino rabbits.
Endpoint:
skin irritation: in vivo
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
supporting study
Study period:
2004-04-13 to 2004-04-16
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Justification for type of information:
see attachment “Read-across concept – Human Health/Environment - Category approach for Inorganic sulfites/thiosulfates/dithionite" in section 13.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
2002-04-24
Deviations:
yes
Remarks:
, occlusive dressing (not considered to influence the results of the study)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS - albino rabbits
- Source: Allevamento "Conelli" - Arona (NO)
- Weight at study initiation: 2820 - 2950 g
- Housing: individual housing in cages (NORYL; polyphenylenoxid; 48.2 cm x 63 cm x 37 cm)
- Diet: standard pellets (Harlan Italy)
- Water (ad libitum): cleaned water
- Acclimation period: one week

ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
60 minutes as well as 24, 48, and 72 hours after application
Number of animals:
3 male rabbits
Details on study design:
TEST SITE
- Area of exposure: 24 hours before the test item application the backs and the hips of the rabbits were shaved (area: 240 cm²). The test item was applied onto a gauze patch (2.5 cm x 2.5 cm), which was placed onto the shaved skin and secured with a plaster.

REMOVAL OF TEST SUBSTANCE
- Washing: after exposure the bandage and plaster were removed. The test substance was removed from the skin with physiological solution.

SCORING SYSTEM: according to the Draize scale

OBSERVATIONS:
- clinical signs were observed daily
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
None of the rabbits showed any signs of skin irritation or oedema.
Interpretation of results:
GHS criteria not met
Conclusions:
Ammonium bisulfite solution 70% is not irritating to the skin of the rabbits.
According to the Regulation (EC) No 1272/2008 and subsequent regulations, the test item should not be classified as irritating to the skin.
Endpoint:
skin irritation: in vivo
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
2004-04-13 to 2004-04-16
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Justification for type of information:
see attachment “Read-across concept – Human Health/Environment - Category approach for Inorganic sulfites/thiosulfates/dithionite" in section 13.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
2002-04-24
Deviations:
yes
Remarks:
, occlusive dressing (not considered to influence the results of the study)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS - albino rabbits
- Source: Allevamento "Conelli" - Arona (NO)
- Weight at study initiation: 2820 - 2950 g
- Housing: individual housing in cages (NORYL; polyphenylenoxid; 48.2 cm x 63 cm x 37 cm)
- Diet: standard pellets (Harlan Italy)
- Water (ad libitum): cleaned water
- Acclimation period: one week

ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
60 minutes as well as 24, 48, and 72 hours after application
Number of animals:
3 male rabbits
Details on study design:
TEST SITE
- Area of exposure: 24 hours before the test item application the backs and the hips of the rabbits were shaved (area: 240 cm²). The test item was applied onto a gauze patch (2.5 cm x 2.5 cm), which was placed onto the shaved skin and secured with a plaster.

REMOVAL OF TEST SUBSTANCE
- Washing: after exposure the bandage and plaster were removed. The test substance was removed from the skin with physiological solution.

SCORING SYSTEM: according to the Draize scale

OBSERVATIONS:
- clinical signs were observed daily
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
None of the rabbits showed any signs of skin irritation or oedema.
Interpretation of results:
GHS criteria not met
Conclusions:
Potassium bisulfite solution is not irritating to the skin of the rabbits.
According to the Regulation (EC) No 1272/2008 and subsequent regulations, the test item should not be classified as irritating to the skin.
Endpoint:
skin irritation: in vivo
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
supporting study
Study period:
2004-04-13 to 2004-04-16
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Justification for type of information:
see attachment “Read-across concept – Human Health/Environment - Category approach for Inorganic sulfites/thiosulfates/dithionite" in section 13.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
2002-04-24
Deviations:
yes
Remarks:
, occlusive dressing (not considered to influence the results of the study)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS - albino rabbits
- Source: Allevamento "Conelli" - Arona (NO)
- Weight at study initiation: 2820 - 2950 g
- Housing: individual housing in cages (NORYL; polyphenylenoxid; 48.2 cm x 63 cm x 37 cm)
- Diet: standard pellets (Harlan Italy)
- Water (ad libitum): cleaned water
- Acclimation period: one week

ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
60 minutes as well as 24, 48, and 72 hours after application
Number of animals:
3 male rabbits
Details on study design:
TEST SITE
- Area of exposure: 24 hours before the test item application the backs and the hips of the rabbits were shaved (area: 240 cm²). The test item was applied onto a gauze patch (2.5 cm x 2.5 cm), which was placed onto the shaved skin and secured with a plaster.

REMOVAL OF TEST SUBSTANCE
- Washing: after exposure the bandage and plaster were removed. The test substance was removed from the skin with physiological solution.

SCORING SYSTEM: according to the Draize scale

OBSERVATIONS:
- clinical signs were observed daily
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
None of the rabbits showed any signs of skin irritation or oedema.
Interpretation of results:
GHS criteria not met
Conclusions:
Sodium bisulfite solution 25% is not irritating to the skin of the rabbits.
According to the Regulation (EC) No 1272/2008 and subsequent regulations, the test item should not be classified as irritating to the skin.
Endpoint:
skin irritation: in vivo
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Minor deviations with no effect on the results: - Purity and stability were 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:
see attachment “Read-across concept – Human Health/Environment - Category approach for Inorganic sulfites/thiosulfates/dithionite" in section 13.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1981-05-12
Deviations:
yes
Remarks:
, see "rationale for reliability"
GLP compliance:
no
Specific details on test material used for the study:
not specified
Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Firma Gaukler; 6050 Offenbach/Main
- Weight at study initiation: Mean weight males: 3.03 kg; mean weight females: 2.80 kg (Individual weights of the test animals: 3.26 kg (male); 2.98 kg (female); 2.79 kg (male); 2.62 kg (female))
- Housing: The animals were housed individually; Cage made of stainless steel with wire mesh walk floor, floor area: 40 cm x 51 cm; No bedding in the cages; sawdust in the waste trays
- Diet: Ovator Solikanin 4 mm; Muskator-Werke, 4000 Düsseldorf, FRG (about 130 g per animal per day)
- Drinking water: About 250 ml per animal per day: fully demineralized water (Monday - Friday), tap water (Saturday/Sunday)
- Acclimatization period: About 8 days before the beginning of the study in the skin laboratory; same housing conditions as during the study.

ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 26°C
- Relative humidity: approx. 30 - 70%
- Photoperiod (hrs dark / hrs light): 12/12


Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Applying an approx. 0.5 mm thick layer of the 50 % solution of the test substance (comparable to 0.5 g of the test substance).
Duration of treatment / exposure:
4 hours
Observation period:
8 days; Readings at 30-60 minutes after application as well as at 24 hours, 48 hours and 8 days after start of application
Number of animals:
2 males / 2 females
Details on study design:
TEST SITE
- Area of exposure: The fur of the rabbits was clipped at least 15 hours before the beginning of the study. The application area was 2.5 cm X 2.5 cm on the upper third of the back or flanks. The test patch was covered with the test substance. In order to prepare the solution distilled water was used. The untreated skin sites of the same animals was used as negative control.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test substance was removed with lutrol and lutrol/water (1:1).
- Time after start of exposure: At the end of the exposure period

SCORING SYSTEM: Draize scoring system
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: In the raw data no observation for 72 hours was included. Since at the 48 hours reading no skin irritation was observed, it was concluded that it could be safely assumed that no skin irritation was present at the 72 hour reading (erythema = 0).
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: In the raw data no observation for 72 hours was included. Since at the 48 hours reading no skin irritation was observed, it was concluded that it could be safely assumed that no skin irritation was present at the 72 hour reading (oedema = 0).
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: In the raw data no observation for 72 hours was included. Since at the 48 hours reading no skin irritation was observed, it was concluded that it could be safely assumed that no skin irritation was present at the 72 hour reading (erythema = 0).
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: In the raw data no observation for 72 hours was included. Since at the 48 hours reading no skin irritation was observed, it was concluded that it could be safely assumed that no skin irritation was present at the 72 hour reading (oedema = 0).
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: In the raw data no observation for 72 hours was included. Since at the 48 hours reading no skin irritation was observed, it was concluded that it could be safely assumed that no skin irritation was present at the 72 hour reading (erythema = 0).
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: In the raw data no observation for 72 hours was included. Since at the 48 hours reading no skin irritation was observed, it was concluded that it could be safely assumed that no skin irritation was present at the 72 hour reading (oedema = 0).
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #4
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: In the raw data no observation for 72 hours was included. Since at the 48 hours reading no skin irritation was observed, it was concluded that it could be safely assumed that no skin irritation was present at the 72 hour reading (erythema = 0).
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: In the raw data no observation for 72 hours was included. Since at the 48 hours reading no skin irritation was observed, it was concluded that it could be safely assumed that no skin irritation was present at the 72 hour reading (oedema = 0).
Irritant / corrosive response data:
At the 8 day reading no erythema or oedema werte observed.
Other effects:
No data

Results:

Readings Animal Erythema Edema Additional findings
24 h 1 1 0  
2 1 0  
3 1 0 overlapping erythema
4 1 0  
48 h 1 0 0  
2 0 0  
3 0 0  
4 0 0  
8 d 1 0 0  
2 0 0  
3 0 0  
4 0 0  
mean 24 - 48 h 1 0.5 0.0  
2 0.5 0.0  
3 0.5 0.0  
4 0.5 0.0  
mean   0.5 0.0  
Interpretation of results:
GHS criteria not met
Conclusions:
Sodium sulphite is not an 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 based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
Minor deviations with no effect on the results: - Purity and stability were not stated. - According to guideline, the 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 72 days after start of exposure. - A modified Draize scoring system was used in this study. - According to the guideline the test substance should be moistened with water. In this study the test patch was moistend with water for application instead of the test substance. - The water supply was not unrestricted. - in the study report it was stated that observations were made at 30-60 minutes after patch removal. In the result table data were listed for an observation at 4-hours.
Justification for type of information:
see attachment “Read-across concept – Human Health/Environment - Category approach for Inorganic sulfites/thiosulfates/dithionite" in section 13.
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1981-05-12
Deviations:
yes
Remarks:
, see "rationale for reliability"
GLP compliance:
not specified
Specific details on test material used for the study:
not specified
Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Savo; Med. Versuchstierzuchten GmbH; 7964 Kisslegg/Allgäu FRG
- Weight at study initiation: mean weight 2.56 kg (Individual weights of the three test animals:2.78 kg, 2.22 kg, and 2.68 kg)
- Housing: The animals were individually housed. The animals were housed in fully air-conditioned rooms. Cage made of stainless steel with wire mesh walk floors. Floor area: 40 cm X 51 cm. No bedding in the cages.Sawdust in the waste trays.
- Diet: Kliba 341, 4 MM; Firma Klingentalmuehle AG, CH- 4303 Kaiseraugst, Switzerland (about 130 g per animal per day)
- Water: About 250 ml tap water per animal per day
- Acclimation period: At least 8 days before the beginning of the study; same housing conditions as during the study.

ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 24 °C
- Relative humidity: 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): A dose of 0.5 g of the unchanged test substance.
Duration of treatment / exposure:
4 hours
Observation period:
72 hours; Readings of skin irritation at 30 - 60 minutes after removal of the test patches and 24 h, 48 h and 72 h after the beginning of application.
Number of animals:
3 male rabbits
Details on study design:
TEST SITE
The fur of the rabbits was clipped at least 15 hours before the beginning of the study.The application area was 2.5 cm X 2.5 cm on the upper third of the back or flanks. The test patch (2.5 cm X 2.5 cm) was covered with a dose of 0.5 g of the unchanged test substance and has been moistened with aqua dest.. Test patches were secured in position with a porous dressing (four layers of absorbant gauze and porous bandage). The untreated skin sites of the same animals was used as negative control.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test substance was removed with lutrol and lutrol/water (1:1).
- Time after start of exposure: At the end of the exposure period

SCORING SYSTEM: Modified Draize scoring system
Evaluation of erythema (R) and oedema (ED):
0 = none
1 = very slight
2 = well-defined
3 = moderate to severe
4 = severe to very severe
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: The readings were made 24 h, 48 h and 72 h after the beginning of application
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: The readings were made 24 h, 48 h and 72 h after the beginning of application
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: The readings were made 24 h, 48 h and 72 h after the beginning of application
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: The readings were made 24 h, 48 h and 72 h after the beginning of application
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: The readings were made 24 h, 48 h and 72 h after the beginning of application
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
Very slight erythema was observed in two animals at the 4-hour reading, which had disappeared at the 24 hour reading.
Interpretation of results:
GHS criteria not met
Conclusions:
The substance is not irritating to the skin based on an in vivo study (OECD 404).
According to the EC Regulation No. 1272/2008 and subsequent regulations, the test item is not classified as skin irritant.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2002-10-08 to 2002-11-12
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
,the weights of the animals were not determined at the end of the study.
GLP compliance:
yes (incl. QA statement)
Remarks:
signed 2001-09-24
Specific details on test material used for the study:
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Strain: New Zealand White A1077 INRA (SPF)
- Source: Centre Lago S.A., Vonnas, France
- Age at study initiation: 3 - 4 months
- Weight at study initiation: 2.75 kg - 2.93 kg (Individual weights of the three rabbits: 2.77 kg (male), 2.75 (female) and 2.93 kg (female))
- Housing: The animals were individually housed. The animals were housed in fully air-conditioned rooms. Stainless steel wire mesh cages with grating, floor area: 3000 cm^2
- Diet: Kliba-Labordiaet (Provimi Kliba SA, Kaiseraugst, Switzerland), about 130 g/animal per day
- Water (ad libitum): Tap water
- Acclimation period: At least 5 days before the beginning of the study

ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 24 °C
- Relative humidity: 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Each animal received a single application of 0.1 ml bulk volume (about 97 mg of the comminuted test substance) of undiluted test substance into the conjunctival sac of the right eye. The left eye was left untreated and served as negative control.



Duration of treatment / exposure:
24 hours
Observation period (in vivo):
14 days; Readings of eye irritation at approx. 1, 24, 48 and 72 h after application and then in weekly intervals.
Number of animals or in vitro replicates:
1 male / 2 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The substance was washed out with tap water.
- Time after start of exposure: About 24 hours after application (before 24 hour reading).

SCORING SYSTEM: Draize scoring system
In addition, evaluations were made of discharge from the eye and the area of cornea affected by the lesions.
Area of cornea involved (ar):
1 = >0≤1/4
2 = > 1/4< 1/2
3 = > 1/2 < 3/4
4 = >3/4

Discharge (di):
0 = No discharge
1 = Any amount different from normal (does not inlcude small amounts observed in inner canthus of normal animals)
2 = Discharge with moistening of the lids and hairs just adjacent to lids
3 = Discharge with moistening of the lids and hairs, and considerable area around the eye

ADDITIONAL OBSERVSATION:
It was checked for dead or moribund animals twice each workday (beginning and end) and once on saturdays, sundays and on public holidays.
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal #1
Time point:
24/48/72 h
Score:
2.67
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal #2
Time point:
24/48/72 h
Score:
2.67
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal #3
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
Moderate or severe conjunctival redness (grade 2 or 3), moderate conjunctival chemosis (grade 2) and slight discharge (grade 1) were observed in all animals 1 hour after application.
Severe conjunctival redness, observed in all animals at the 24-hour reading, persisted in two animals up to 48 hours and decreased to moderate 72 hours after application. In the other animal severe conjunctival redness decreased to slight (grade 1) 7 days after application.
Moderate conjunctival chemosis decreased in two animals to slight (grade 1) 24 hours after application and was seen in one of these animals up to the 72-hour reading. The third animal exhibited moderate conjunctival chemosis at 24 hours which diminished to slight 48 hours after application.
Additionally, circular injected scleral vessels were noted in all animals 1 hour after application, which reduced to a circumscribed area at the 24-hour reading in all animals and persisted up to 48 hours in one animal and up to 72 hours in the other two animals. Moreover, one animal showed a white discoloration at the nictitating membrane 48 and 72 hours after application.
The ocular reactions were reversible in two animals within 7 days and in one animal within 14 days after appplication.
Other effects:
not stated
Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
The substance is irritating to the eyes.
According to the EC Regulation No. 1272/2008 and subsequent regulations, the test item is classified as Category 2.
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2005-08-08 to 2005-12-21
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
2002-04-24
Deviations:
yes
Remarks:
, according to the guideline distilled water or saline should be used for rinsing the eye after treatment with the test item, but in the study tap water was used for rinsing the eye.
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Strain: New Zealand White A1077 INRA (SPF)
- Source: Centre Lago S.A., 01540 Vonnas, France
- Age at study initiation: 3 - 4 months
- Weight at study initiation: 2.92 kg - 3.05 kg (Individual weights of the three animals: 2.92 kg (male), 3.00 kg (female), and 3.05 kg (male))
- Housing: The animals were housed individually. The animals were housed in fully air-conditioned rooms. Stainless steel wire mesh cages with grating, floor area: 3000 cm^2.
- Diet: Kliba-Labordiaet ((Kaninchen & Meerschweinchenhaltung "GLP") Provimi Kliba SA, Kaiseraugst, Basal, Switzerland), about 130 g/animal per day
- Water (ad libitum): Tap water
- Acclimation period: At least 5 days before the beginning of the study

ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 24 °C
- Relative humidity: 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12/12

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Each animal received a single application of 0.1 ml bulk volume (about 53 mg of the comminted test substance) of undiluted test substance into the conjunctival sac of the right eye. The untreated eye served as negative control.
Duration of treatment / exposure:
about 1 hour
Observation period (in vivo):
7 days; Readings of eye irritation were made approx. 1, 24, 48, and 72 h after application and on day 7.
Number of animals or in vitro replicates:
2 males / 1 female
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treated eye of the animal(s) was rinsed with 3 to 6 mL of hand warm tap water for 1 to 2 minutes using a syringe with a blunt probe.
- Time after start of exposure: About 1 hour after application of the solid test substance.

SCORING SYSTEM: Draize scoring system
In addition, evaluations were made of discharge from the eye and the area of cornea affected by the lesions.
Area of cornea involved (ar):
1 = >0≤1/4
2 = > 1/4< 1/2
3 = > 1/2 < 3/4
4 = >3/4

Discharge (di):
0 = No discharge
1 = Any amount different from normal (does not inlcude small amounts observed in inner canthus of normal animals)
2 = Discharge with moistening of the lids and hairs just adjacent to lids
3 = Discharge with moistening of the lids and hairs, and considerable area around the eye

TOOL USED TO ASSESS SCORE: Daylight tubes "Lumilux" (L 58W/860 PLUS ECO 25X1, Osram, Germany)

ADDITIONAL OBSERVSATION:
It was checked for dead or moribund animals twice each workday (beginning and end) and once on saturdays, sundays and on public holidays.
the body weight was determined just before application of the test substance and after the last reading.
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal #2
Time point:
24/48/72 h
Score:
2.67
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal #3
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritant / corrosive response data:
Moderate or severe conjunctival redness (grade 2 or 3) were noted in the animals from 1 hour up to 72 hours after application. Slight or moderate conjunctival chemosis (grade 1 or 2) were noted in all animals 1 hour after application. Slight conjunctival chemosis, observed in two animals after 24 and 48 hours, persisted in one animal up to 72 hours. Slight or moderate discharge (grade 1 or 2) was noted in all animals 1 hour after application, only.
Additionally, injected scleral vessels in a circumscribed area or circular were noted in all animals up to 24 hours after application.
The ocular reactions were reversible in all animals within 7 days after application.
Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
Hydrosulfit PF is considered to be irritant to the eye.
According to the EC Regulation No. 1272/2008 and subsequent regulations, the test item is classified as Category 2.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

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

Additional information

Read-across concept for sulfites, hydrogensulfites, metabisulfites, dithionites and thiosulfates:

A comprehensive read-across concept has been developed for sulfites, hydrogensulfites and metabisulfites, based on the pH-dependant equilibrium in aqueous solutions which is summarised in the following equations:[1], [2]

SO2+ H2O <->`H2SO3´        H2SO3<-> H++ HSO3-<-> 2H++SO32-   2HSO3-<->H2O +S2O52-

In consequence, under most physiological circumstances, sulfite and hydrogensulfite anions will be present in almost equimolar quantities, irrespective of their origin either as sulfites, hydrogensulfites and metabisulfites. Unrestricted read-across between the groups of sulfites, hydrogensulfites and metabisulfites is therefore considered justified. Since the nature of the cations such as sodium, potassium and ammonium is not assumed to contribute substantially to differences in toxicity and solubility (all compounds are very soluble in water), only the chemical and biological properties of the anionic sulfite moiety are considered as relevant determinants.

Further, it is well established that sodium dithionite is unstable in water, thereby disproportionating to form sodium hydrogen sulfite and sodium thiosulfate (equation II)[1], so that this substance is also considered to be covered by the read-across concept described above. Since the substance is not stable enough under physiological conditions to fulfil the requirements of most HH test guidelines, instead the products of decomposition have to be considered:

      2 S2O42-+ H2O→2HSO3-+ S2O32-

 [1]Hollemann Wiberg, Lehrbuch der Anorganischen Chemie, 101.Auflage

[2]Handbook of Chemistry and Physics, Ed. Lide, DR, 88thedition, CRC Press

Like all “sulfite substances”, the dithionite anion has strongly reducing properties and decomposes/disproportionates rapidly in aqueous media (especially under acidic anaerobic conditions) to form sulfite and thiosulfate (S2O32-); under aerobic conditions, it will additionally be oxidised to finally form sulfate as the final oxiodation/decomposition product. According to Hofmann and Rüdorff (1969) and Holleman and Wiberg (1995), this process can roughly be described by the following equations (under aerobic conditions and at low concentrations, reaction (2) is favoured:

 

2 Na2S2O4+ H2ONa2S2O3+ 2 NaHSO3(anaerobic conditions) (1), as described above

 

Na2S2O4+ O2+ H2ONaHSO4+ NaHSO3(aerobic conditions) (2)

 

According to the literature overview of Münchow (1992) the following principal decomposition patterns can be described for dithionite in relation to pH ranges at temperatures between 0°C and 32°C for 0.0025 molar solutions:

 

strongly alkaline medium: 3 S2O42-+ 6 OH-5 SO32-+ S2-+ 3H2O

weakly alkaline to weakly acidic medium: 2 S2O42-+ H2O2 HSO3-+ S2O32-

acidic medium: 2 H2S2O43 SO2+ S + 2 H2O

strongly acidic medium: 3 H2S2O45 SO2+ H2S + 2 H2O  

With limitations, this read-across concept also extends to the substance class of thiosulfates: although the thiosulfates are also well known to disproportionate in aqueous solution to form polythionic acids and SO2(HSO3-), this requires somewhat more acidic conditions. Therefore, read-across to sulfites is primarily restricted to corresponding physiological conditions such as oral administration where the gastric passage with the strongly acidic conditions in the stomach will facilitate the chemical disproportionation described below:

      HS2O3-+ H2S2O3→HS3O3-+ SO2+ H2O

 

Skin irritation:

Skin irritation data specifically for sodium dithionite are not available, which is why read-across to similar substances (sodium and potassium sulfite as well as ammonium, sodium and potassium hydrogensulfite) is made.One in vivo study (Kirsch, 1989) on dermal irritation of potassium sulfite was identified which was conducted according to OECD guideline 404. The test read-across test item showed no skin irritating properties. No erythema or oedema were seen in any of the rabbits at 24, 48, 72 hours after the beginning of the study. Very slight erythema was observed in two animals at the 4-hour reading, which had disappeared at the 24 hour reading.

One further in-vivo study for the read-across substance sodium sulfite (Grundler, 1981) equivalent or similar to OECD 404, used for read-across is available. No skin irritating properties of sodium sulfite could be determined.

Three study reports equivalent or similar to OECD 404, prepared by Consonni (2004) for the substances ammonium hydrogensulfite, sodium hydrogensulfite and potassium hydrogensulfite indicated no irritation properties when applied as aqueous solution (70%, 40% and 32%; substances as such are not existent in dry form). Erythema and edema scores were zero after 24, 48 and 72h for all substances.

Another in vivo study on dermal irritation of ammonium thiosulfate is merely of supportive nature (reliability 3) (Lemen, 1988). There were either only mild signs of erythema, oedema or other dermal effects in both studies, or none at all. Based on the outcome of the above mentioned studies and the proposed read-across approach, sodium dithionite is considered as not irritating to the skin.

For the transformation product “thiosulfte”, only an unreliable (reliability 3) in vivo skin irritation study but with a negative outcome for ammonium thiosulfate (CAS 7783-18-8) is available and is therefore used as supporting information. Based on read-across from sodium sulfite (CAS 7757-83-7), ammonium thiosulfate does not require classification as a skin irritant.

 

Eye irritation:

Two in-vivo studies, according to OECD guideline 405specificallyfor sodium dithionite are availablewhich is why read-across was not considered to be required.One study (Remmele, 2006) indicated that sodium dithionite is not irritating to the eye. Moderate or severe conjunctival redness (grade 2 or 3) were noted in the animals from 1 hour up to 72 hours after application. Slight or moderate conjunctival chemosis (grade 1 or 2) were noted in all animals 1 hour after application. Slight conjunctival chemosis, observed in two animals after 24 and 48 hours, persisted in one animal up to 72 hours. Slight or moderate discharge (grade 1 or 2) was noted in all animals 1 hour after application, only. Additionally, injected scleral vessels in a circumscribed area or circular were noted in all animals up to 24 hours after application. The ocular reactions were reversible in all animals within 7 days after application.

The study Kaufmann (2003) indicates that sodium dithionite has eye irritating properties. Moderate or severe conjunctival redness (grade 2 or 3), moderate conjunctival chemosis (grade 2) and slight discharge (grade 1) were observed in all animals 1 hour after application. Severe conjunctival redness, observed in all animals at the 24-hour reading, persisted in two animals up to 48 hours and decreased to moderate 72 hours after application. In the other animal severe conjunctival redness decreased to slight (grade 1) 7 days after application. Moderate conjunctival chemosis decreased in two animals to slight (grade 1) 24 hours after application and was seen in one of these animals up to the 72-hour reading. The third animal exhibited moderate conjunctival chemosis at 24 hours which diminished to slight 48 hours after application. Additionally, circular injected scleral vessels were noted in all animals 1 hour after application, which reduced to a circumscribed area at the 24-hour reading in all animals and persisted up to 48 hours in one animal and up to 72 hours in the other two animals. Moreover, one animal showed a white discoloration at the nictitating membrane 48 and 72 hours after application. The ocular reactions were reversible in two animals within 7 days and in one animal within 14 days after appplication.

For the transformation product (ammonium) thiosulfate, a study with negative outcome is available, thereby substantiating the conclusion that sodium dithionate does not qualify as an eye irritant.


Effects on eye irritation: irritating

Justification for classification or non-classification

Skin irritation:

(for additional information, see `discussion´)

References Kirsch, J. (1989) and Grundler, O.J. (1981) are considered as key studies for skin irritation and will be used for classification. The overall irritation results are as follows:

Read-across: Kirsch, J. (1989):

Erythema, edema, 24, 48, 72h after application: max score = 0

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.

 

Read-across: Grundler, O.J. (1981):

(for additional information, see `discussion´)

Erythema, 24, 48, 72h after application: max score =1, mean score = 0.33.

Edema, 24, 48, 72h after application: max score = 0

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.

 

Read-across: Consonni (2004):

Three study reports equivalent or similar to OECD 404, prepared by Consonni (2004) for the substances ammonium hydrogensulfite, sodium hydrogensulfite and potassium hydrogensulfite indicated no irritation properties when applied as aqueous solution (70%, 40% and 32%; substances as such are not existent in dry form). Erythema and edema scores were zero after 24, 48 and 72h for all substances.

According to the criteria specified by Directive 67/548/EEC and subsequent regulations, the test items are not classified as skin irritant. According to the EC Regulation No. 1272/2008 and subsequent regulations, the test items are not classified as skin irritant.

Based on the outcome of the read-across studies, it can be concluded, that sodium dithionite is not irritating to the skin and has not to be classified according to the criteria specified by Directive 67/548/EEC and subsequent regulations and according to the EC Regulation No. 1272/2008 and subsequent regulations.

Eye irritation:

The references Remmele (2006) and Kaufmann (2003) are considered as key studies and will be used for classification.The overall results are as follows:

Remmele (2006):

Animal #1:

Corneal opacity: mean score, 24, 48 and 72h after application = 0

Iris: mean score, 24, 48 and 72h after application = 0

Chemosis: mean score, 24, 48 and 72h after application = 1

Conjunctivae, 24, 48 and 72h after application: mean score = 2

Animal #2:

Corneal opacity: mean score, 24, 48 and 72h after application = 0

Iris: mean score, 24, 48 and 72h after application =0

Chemosis: mean score, 24, 48 and 72h after application = 0

Conjunctivae, 24, 48 and 72h after application: mean score = 2.67

Animal #3:

Corneal opacity: mean score, 24, 48 and 72h after application = 0

Iris: mean score, 24, 48 and 72h after application = 0

Chemosis: mean score, 24, 48 and 72h after application = 0.67

Conjunctivae, 24, 48 and 72h after application: mean score = 2

 

According to the criteria specified by Directive 67/548/EEC and subsequent regulations, the test item is not classified as eye irritant . According to the EC Regulation No. 1272/2008 and subsequent regulations, the test item should be classified as eye irritant (Eye Dam.2, H319).

Kaufmann (2003):

Animal #1:

Corneal opacity: mean score, 24, 48 and 72h after application = 0

Iris: mean score, 24, 48 and 72h after application = 0

Chemosis: mean score, 24, 48 and 72h after application = 1

Conjunctivae, 24, 48 and 72h after application: mean score = 2.67

Animal #2:

Corneal opacity: mean score, 24, 48 and 72h after application = 0

Iris: mean score, 24, 48 and 72h after application =0

Chemosis: mean score, 24, 48 and 72h after application = 0.33

Conjunctivae, 24, 48 and 72h after application: mean score = 2.67

Animal #3:

Corneal opacity: mean score, 24, 48 and 72h after application = 0

Iris: mean score, 24, 48 and 72h after application = 0

Chemosis: mean score, 24, 48 and 72h after application = 1

Conjunctivae, 24, 48 and 72h after application: mean score = 3

According to the criteria specified by Directive 67/548/EEC and subsequent regulations, the test item should be classified as eye irritant (R36). According to the EC Regulation No. 1272/2008 and subsequent regulations, the test item should be classified as eye irritant (Eye Dam.2, H319).

 

Respiratory irritation:

The classification as respiratory irritant is covered under the endpoint specific target organ toxicity- single exposure and repeated exposure. Please refer to the endpoint summaries on acute toxicity (endpoint 7.2) and repeated dose toxicity (endpoint 7.5) for further information.