Registration Dossier

Administrative data

Description of key information

Skin irritation, rabbits, OECD 404, not irritating to the skin
Eye irritation, rabbits, OECD 405, not irritating to eyes
Eye irritation, rabbits, OECD 405, not irritating to eyes

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Between 22 September and 5 October 1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted in compliance with agreed protocols, OECD Guidelines and to GLP standards, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Young adult animals weighing 3209 to 3587 grams at initiation of dosing were identified by eartag and housed in individual suspended wire mesh cages. The animals were acclimated to laboratory conditions for a minimum of seven days prior to dosing. They were provided PMI Nutrition International, Inc Certified Rabbit LabDiet(R) 5322 feed (approx. 150g/day) during the study and Municipal water ad libitum. Environmental conditions were controlled: 68.2-69.1 deg F, 35.8 to 64.1 % humidity and 12 hours light/12 hour dark cycles.
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 ml
Duration of treatment / exposure:
4 h
Observation period:
13 days
Number of animals:
6
Details on study design:
A group of 6 animals were acclimated for a minimum of 7 days. A dose of 0.5 ml then was applied to a shaved, unabraded site on each animal. A semi-occlusive wrapping was applied to hold the test material in place. At the end of a 4 hours, the wrapping was removed and the site was wiped with a disposable towel moistened with deionized water to remove the test material. The test sites were then evaluated in accordance with the method of Draize at approximately 30-60 minutes, 24, 48 and 72 hours and daily through day 13 if irritation persisted. Animals were observed twice daily for mortality, and body weights were recorded at day 0 and termination.
Irritation parameter:
erythema score
Remarks:
(intact skin)
Basis:
mean
Time point:
other: 24 hours
Score:
1.83
Max. score:
4
Reversibility:
fully reversible within: day 13
Irritation parameter:
erythema score
Remarks:
(intact skin)
Basis:
mean
Time point:
other: 48 Hours
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: day 13
Irritation parameter:
erythema score
Remarks:
(intact skin)
Basis:
mean
Time point:
other: 72 Hours
Score:
1.83
Max. score:
4
Reversibility:
fully reversible within: day 13
Irritation parameter:
edema score
Remarks:
(intact skin)
Basis:
mean
Time point:
other: 24 Hours
Score:
0.17
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
edema score
Remarks:
(Initact skin)
Basis:
mean
Time point:
other: 48 Hours
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Remarks:
(intact skin)
Basis:
mean
Time point:
other: 72 Hours
Score:
0
Max. score:
4
Reversibility:
fully reversible
Other effects:
No mortality or effects on body weight were observed.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: EU-GHS
Conclusions:
In accordance with EU CLP Regulation (EC) No. 1272/2008 this substance is not classified as a skin irritant.
Executive summary:

A study was undertaken in 1999 (Kerr, 1999) to investigate the skin irritation potential of Magnesium sulfonate (CAS 231297 -75 -9) in New Zealand White rabbits. A group of 6 animals were acclimated for a minimum of 7 days. A dose of 0.5 ml then was applied to a shaved, unabraded site on each animal using OECD Guideline 404. A semi-occlusive wrapping was applied to hold the test material in place. At the end of a 4 hours, the wrapping was removed and the site was wiped with a disposable towel moistened with deionized water to remove the test material. The test sites were then evaluated in accordance with the method of Draize at approximately 30-60 minutes, 24, 48 and 72 hours and daily through day 13 if irritation persisted. Animals were observed twice daily for mortality, and body weights were recorded at day 0 and at termination. Mean erythema scores at 24, 48 and 72 hours were 1.83, 1.67, and 1.83, respectively and were fully reversible by day 13. Mean oedema scores at 24, 48 and 72 hours were 0.17, 0, and 0, respectively and were fully reversible by 48 hours. No mortality or effects on body weight were observed. Based on the results of this study this substance is not classified as a skin irritant in accordance with EU CLP Regulation (EC) No. 1272/2008.

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Study period:
Between 28 February 1972 and 21 March 1972
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study has been well conducted, but not to GLP, nor fully reported.
Qualifier:
no guideline followed
Principles of method if other than guideline:
The test material was applied to two areas of the backs and flanks of 6 albino rabbits. 0.5 ml of test substance was applied to the sites (one abraded, one intact) and covered with a gauze patch. The substance was applied for 24 hours, before scoring for oedema and erythema was undertaken. Scoring was also performed after 72 hours.
GLP compliance:
no
Species:
rabbit
Strain:
other: albino
Type of coverage:
occlusive
Preparation of test site:
other: shaved, abraded and unabraded
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:
24 hours
Observation period:
24 and 72 hours post dosing
Number of animals:
6
Irritation parameter:
erythema score
Remarks:
Animal 1
Basis:
mean
Time point:
other: 24h/72h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Remarks:
Animal 2
Basis:
mean
Time point:
other: 24h/72h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Remarks:
Animal 3
Basis:
mean
Time point:
other: 24h/72h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Remarks:
Animal 4
Basis:
mean
Time point:
other: 24h/72h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Remarks:
Animal 5
Basis:
mean
Time point:
other: 24h/72h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Remarks:
Animal 6
Basis:
mean
Time point:
other: 24h/72h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Remarks:
Animal 1
Basis:
mean
Time point:
other: 24h/72h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Remarks:
Animal 2
Basis:
mean
Time point:
other: 24h/72h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Remarks:
Animal 3
Basis:
mean
Time point:
other: 24h/72h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Remarks:
Animal 4
Basis:
mean
Time point:
other: 24h/72h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Remarks:
Animal 5
Basis:
mean
Time point:
other: 24h/72h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Remarks:
Animal 6
Basis:
mean
Time point:
other: 24h/72h
Score:
0
Max. score:
0
Irritant / corrosive response data:
Mean score calculated by average of results at 24h, and 72h for each animal.

Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility

Erythema

Oedema

Max. score: 0

Max. score: 0

24 h

 0/0/0/0/0/0

0/0/0/0/0/0 

72 h

 0/0/0/0/0/0

 0/0/0/0/0/0

Average 24h, 72h

 0/0

 0/0

Reversibility*)

 

 

Average time (unit) for reversion

 

 

*) Reversibility: c. = completely reversible;= not completely reversible; n. = not reversible

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: EU-GHS
Conclusions:
Mean scores for each animal at 24h, and 72 h for erythema and oedema, respectively, were 0. Therefore, this substance is not irritating to skin under the conditions of this test.
Executive summary:

In a primary dermal irritation study, 6 young adult albino rabbits were dermally exposed to 0.5 mL of sodium 4-icosylbenzenesulfonate for 24 hours. Animals then were observed for 72 hours. In this study, sodium 4-icosylbenzenesulfonate is not a dermal irritant.

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Study period:
Between 28 December 1990 and 18 January 1991
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Conducted to guidelines and to GLP.
Qualifier:
equivalent or similar to
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
no
Remarks:
24 hour and 72 hour observation
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Myrtle's Rabbitry
- Housing: Wire mesh suspension cage
- Diet (e.g. ad libitum): Purina Laboratory Rabbit chow ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 1 day

ENVIRONMENTAL CONDITIONS
- Temperature (°C):
- Humidity (%):
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle
Type of coverage:
semiocclusive
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

TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.5 ml
- Concentration (if solution): 6.25, 12.5, 25, 50%
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3/sex
Details on study design:
TEST SITE
- Area of exposure: 2.5cm x 2.5cm
- Type of wrap if used: rubber dental dam and gauze

REMOVAL OF TEST SUBSTANCE
- Washing (if done): gentle sponging using dry gauze, or gauze moistened with mineral oil or saline as appropriate
- Time after start of exposure:4 hours

SCORING SYSTEM: Draize
Irritation parameter:
erythema score
Remarks:
Animal 1, 6.25%
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
1.5
Max. score:
2
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
erythema score
Remarks:
Animal 2, 3, 4, 5, 6.25%
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
erythema score
Remarks:
Animal 6, 6.25%
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
1
Max. score:
1
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
edema score
Remarks:
Aniamls 1, 2 and 5, 6.25%
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
0.5
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
edema score
Remarks:
Animal 3, 6.25%
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
0
Max. score:
0
Irritation parameter:
edema score
Remarks:
Animal 4, 6.25%
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
edema score
Remarks:
Aniaml 6, 6.25%
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
1
Max. score:
1
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
erythema score
Remarks:
Animal 1, 12.5%
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
1.5
Max. score:
2
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
erythema score
Remarks:
Animals 2, 3, 4, 6, 12.5%
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
erythema score
Remarks:
Animal 5
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
2.5
Max. score:
3
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
edema score
Remarks:
Animals 1, 2, 3, 6, 12.5%
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
0.5
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
edema score
Remarks:
Animal 4, 12.5%
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
1
Max. score:
1
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
edema score
Remarks:
Animal 5, 12.5%
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
1.5
Max. score:
2
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
erythema score
Remarks:
Animal 1, 5, 6, 25%
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
erythema score
Remarks:
Animals 2 and 3, 25%
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
erythema score
Remarks:
Animal 4, 25%
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
2.5
Max. score:
3
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
edema score
Remarks:
Animals 1 and 6, 25%
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
edema score
Remarks:
Animals 2 and 4, 25%
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
2.5
Max. score:
3
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
edema score
Remarks:
Animal 3, 25%
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
1.5
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
edema score
Remarks:
Animal 5, 25%
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
0.5
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Irritant / corrosive response data:
Erythema score Animal 1, 50%, mean, 24 and 72 hours, 2, 2, not fully reversible within 72 hours
Erythema score Animals 2, 3, 4, 50%, mean, 24 and 72 hours, 3, 3, not fully reversible within 72 hours
Erythema score Animal 5, 50%, mean, 24 and 72 hours, 2.5, 3, not fully reversible within 72 hours
Erythema score Animal 1, 50%, mean, 24 and 72 hours, 1.5, 2, not fully reversible within 72 hours

Oedema score Animals 1 and 3, 50%, mean, 24 and 72 hours, 2.5, 3, not fully reversible within 72 hours
Oedema score Animal 2, 50%, mean, 24 and 72 hours, 3, 4, not fully reversible within 72 hours
Oedema score Animal 4, 50%, mean, 24 and 72 hours, 2.5, 4, not fully reversible within 72 hours
Oedema score Animal 5, 50%, mean, 24 and 72 hours, 2, 2, not fully reversible within 72 hours
Oedema score Animal 6, 50%, mean, 24 and 72 hours, 0.1, 1, not fully reversible within 72 hours

Mean score calculated by average of results at 24h, and 72h for each animal.

Table 2: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility

Erythema 6.25 %

Oedema 6.25%

Erythema 12.5%

Oedema 12.5%  Erythema 25%  Oedema 25%  Erythema 50%  Oedema 50% 

Max. score: 2

Max. score: 2

Max. score:2

Max score: 3  Max score:3  Max score:3  Max score:3  Max score:4  

24 h

2/2/2/2/2/1

1/2/2/2/2/1

2/2/2/2/2/2   1/2/2/2/3/2  2/3/3/3/2/2  3/3/3/3/1/3  2/3/3/3/3/2  3/4/3/4/2/1

72 h

1/1/0/2/1/1

 0/0/0/2/0/1

 1/1/1/1/1/1  0/0/0/1/2/0  2/3/3/2/2/2  1/2/0/2/0/1  2/3/3/3/2/1  2/2/2/1/2/0

Average 24h, 72h

1.8/1

1.7/0.5

 2/1 2/0.5   2.5/2.3  2.7/1  2.7/2.3  2.8/1.5

Reversibility*)

n

 nc

 n  nc  n  n  n  n

Average time (unit) for reversion

 

 

           

*) Reversibility: c. = completely reversible; nc= not completely reversible; n. = not reversible

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: EU-GHS
Conclusions:
Mean scores for each animal at 24h, and 72 h for erythema and oedema, respectively, were less than 2.3. Therefore, this substance is not irritating to skin under the conditions of this test.
Executive summary:

In a primary dermal irritation study, 6 young adult New Zealand white rabbits were dermally exposed to concentrations of 6.25, 12.5, 25 and 50% 0.5 ml sodium 4-icosylbenzenesulfonate for 4 hours. Animals then were observed for 72 hours. Irritation was scored by the method of Draize. In this study, sodium 4-icosylbenzenesulfonate is not a dermal irritant.

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Study period:
Between 13 November 1990 and 16 November 1990
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: conducted to guidelines and to GLP.
Qualifier:
equivalent or similar to
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
yes
Remarks:
2 animals tested, 24 hour and 72 hour observation
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Myrtle's Rabbitry
- Housing: Wire mesh suspension cage
- Diet (e.g. ad libitum): Purina Laboratory Rabbit chow ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 1 day


ENVIRONMENTAL CONDITIONS
- Temperature (°C):
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle
Type of coverage:
semiocclusive
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:
72 hours
Number of animals:
2
Details on study design:
TEST SITE
- Area of exposure: 2.5cm x 2.5cm
- Type of wrap if used: rubber dental dam and gauze


REMOVAL OF TEST SUBSTANCE
- Washing (if done): gentle sponging using dry gauze, or gauze moistened with mineral oil or saline as appropriate
- Time after start of exposure:4 hours


SCORING SYSTEM: Draize
Irritation parameter:
erythema score
Remarks:
Animal 1
Basis:
mean
Time point:
other: 24h and 72h
Score:
2.5
Max. score:
3
Reversibility:
not fully reversible within: 72h
Remarks on result:
other: only two animals were used and only one animal fulfills the criteria for classification, this however is not sufficient for classification of the substance as a skin irritant
Irritation parameter:
erythema score
Remarks:
Animal 2
Basis:
mean
Time point:
other: 24h and 72h
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 72h
Irritation parameter:
edema score
Remarks:
Animal 1
Basis:
mean
Time point:
other: 24h and 72h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 72h
Remarks on result:
other: only two animals were used and only one animal fulfills the criteria for classification, this however is not sufficient for classification of the substance as a skin irritant
Irritation parameter:
edema score
Remarks:
Animal 2
Basis:
mean
Time point:
other: 24h and 72h
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 72h
Irritant / corrosive response data:
Mean score calculated by average of results at 24h, and 72h for each animal.

Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

 

Score at time point / Reversibility

Erythema

Oedema

Max. score: 3

Max. score: 4

24 h

 3/2

 4/2

72 h

 2/2

 2/2

Average 24h, 72h

 2.5/2

 3/2

Reversibility*)

 n

 n

Average time (unit) for reversion

 

 

 

*) Reversibility: c. = completely reversible;= not completely reversible; n. = not reversible

Table 2
Primary Skin Irritation in Rabbits Following a 4-Hour Dermal Application of Calcium sulfonate
Skin Condition Reading Score for each Rabbit*
No. 1 - #317 No. 2 - #347
Erythema Formation
Intact Site A B
24 hr 3S 2S
72 hr 2S 2SQ
Edema Formation
Intact Site A B
24 hr 4 2
72 hr 2   2
  Total Score Average Score
Erythema and Eschar Formation, 24 hours 5 2.50
Erythema and Eschar Formation, 72 hours 4 2.00
Edema Formation, 24 hours 6 3.00
Edema Formation, 72 hours 4 2.00
Primary Irritation Index (Ml) 4.8
* Scoring key appended to report.
S - Spreading of erythema beyond site.
Q - Blanched appearance on site.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Mean scores for each animal at 24h, and 72 h for erythema and oedema, respectively, were less than 2.3. Therefore, this substance is not irritating to skin under the conditions of this test.
Executive summary:

In a primary dermal irritation study, 2 young adult New Zealand white rabbits were dermally exposed to 0.5 ml of sodium 4-icosylbenzenesulfonate for 4 hours. Animals then were observed for 72 hours. Irritation was scored by the method of Draize.

In this study, sodium 4-icosylbenzenesulfonate is not a dermal irritant.

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Study period:
Between 21 January 2002 and 18 March 2002
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted to guidelines and GLP.
Qualifier:
according to
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Sgarlat's Rabbitry, PA
- Weight at study initiation: 2.9-3.1 kg
- Housing: 1 animal/cage in suspended wire cages
- Diet (e.g. ad libitum): Fresh Purina Rabbit Chow
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle
Type of coverage:
semiocclusive
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/rabbit
Duration of treatment / exposure:
4 hours
Observation period:
14 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: plastic

REMOVAL OF TEST SUBSTANCE
- Washing (if done): gentle washing with distilled water
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize
Irritation parameter:
erythema score
Remarks:
Animal 1
Basis:
mean
Time point:
other: 24h/48h/72h
Score:
0.7
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
erythema score
Remarks:
Animal 2
Basis:
mean
Time point:
other: 24h/48h/72h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Remarks:
Animal 3
Basis:
mean
Time point:
other: 24h/48h/72h
Score:
1.7
Max. score:
2
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Remarks:
Animal 1
Basis:
mean
Time point:
other: 24h/48h/72h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Remarks:
Animal 2
Basis:
mean
Time point:
other: 24h/48h/72h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Remarks:
Animal 3
Basis:
mean
Time point:
other: 24h/48h/72h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 14 days
Irritant / corrosive response data:
Mean score calculated by average of results at 24h, 48h, and 72 h for each animal.
Other effects:
Animals did not display any abnormal signs throughout the test period. Bodyweights did not significantly alter.

Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility

Erythema

Oedema

Max. score: 4

Max. score: 2

60 min

1/0/1

 0/0/1

24 h

1/0/1

 0/0/1

48 h

1/0/2

 0/0/1

72 h

0/0/2

 0/0/1

Average 24h, 48h, 72h

 0.7/1/0.7

 0.3/0.3/0.3

Reversibility*)

 c/c/c

 c/c/c

Average time (unit) for reversion

 72/0/14d

 0/0/14d

*) Reversibility: c. = completely reversible;= not completely reversible; n. = not reversible

 

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: EU-GHS
Conclusions:
The substance is determined to be non-irritating.
Executive summary:

In a primary dermal irritation study , 3 young adult New Zealand white rabbits were dermally exposed to 0.5 mL of the calcium sulfonate read across substance (CAS 70024 -96 -0) for 4 hours.  Animals then were observed for 14 days. Irritation was scored by the method of Draize. In this study, Benzenesulfonic acid, mono-C16-24-alkyl derivs., calcium salts is not a dermal irritant.

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Study period:
Between 21 January 2002 and 18 March 2002
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted to guidelines and GLP.
Qualifier:
according to
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Sgarlat's Rabbitry, PA
- Weight at study initiation: 2.7-2.8 kg
- Housing: 1 animal/cage in suspended wire cages
- Diet (e.g. ad libitum): Frsh Purina Rabbit chow
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle
Type of coverage:
semiocclusive
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/rabbit
Duration of treatment / exposure:
4 hours
Observation period:
7 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: plastic

REMOVAL OF TEST SUBSTANCE
- Washing (if done): gentle washing with distilled water
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize
Irritation parameter:
erythema score
Remarks:
Animal 1
Basis:
mean
Time point:
other: 24h/48h/72h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Remarks:
Animal 2
Basis:
mean
Time point:
other: 24h/48h/72h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Remarks:
Animal 3
Basis:
mean
Time point:
other: 24h/48h/72h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Remarks:
Animal 1
Basis:
mean
Time point:
other: 24h/48h/72h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Remarks:
Animal 2
Basis:
mean
Time point:
other: 24h/48h/72h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Remarks:
Animal 3
Basis:
mean
Time point:
other: 24h/48h/72h
Score:
1.3
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
Mean score calculated by average of results at 24h, 48h, and 72 h for each animal.
Other effects:
Animals did not display any abnormal signs throughout the test period. Bodyweight was reduced in one animal.

Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility

Erythema

Oedema

Max. score: 4

Max. score: 2

60 min

1/1/1

1/0/1

24 h

1/1/2

0/0/1

48 h

1/1/2

0/0/1

72 h

1/1/2

0/0/2

Average 24h, 48h, 72h

1.3/1.3/1.3

0.3/0.3/0.6

Reversibility*)

 c/c/c

 c/c/c

Average time (unit) for reversion

 7d/7d/7d

 0/0/7d

*) Reversibility: c. = completely reversible;= not completely reversible; n. = not reversible

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: EU-GHS
Conclusions:
Mean scores for each animal at 24h, 48h, and 72 h for erythema and oedema, respectively, were less than 2.3. Therefore, this substance is not irritating to skin under the conditions of this test.
Executive summary:

In a primary dermal irritation study, 3 young adult New Zealand white rabbits were dermally exposed to 0.5 ml of sodium 4-icosylbenzenesulfonate for 4 hours. Animals then were observed for 7 days. Irritation was scored by the method of Draize. In this study, sodium 4-icosylbenzenesulfonate is not a dermal irritant.

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Study period:
Between 6 October 1999 and 14 October 1999
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted to guidelines and GLP and reported fully.
Qualifier:
according to
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
other: Japanese Agricultural Chemicals Laws & Regulations Testing Guidelines for Toxicology Studies (MAFF) [59 NohSan No. 4200 (1985)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Covance Research Products
- Age at study initiation: Young adult
- Weight at study initiation: 2071 to 2480 g
- Housing: Individual suspended wire mesh cages
- Diet (e.g. ad libitum): LabDiet 150 g/day
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minimum 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C (68.3 - 68.8 °F)
- Humidity (%): 30.2-55%
- Photoperiod (hrs dark / hrs light): 12 hours light/dark cycle
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
Duration of treatment / exposure:
4 hours
Observation period:
60 minutes, 24h, 48h, 72h and 8 days
Number of animals:
3/sex
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: Gauze binder.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Wiped with paper towels moistened with deionised water
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize
Irritation parameter:
erythema score
Remarks:
Animal 1
Basis:
mean
Time point:
other: 24, 48, 72h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 6 days
Irritation parameter:
erythema score
Remarks:
Animal 2
Basis:
mean
Time point:
other: 24, 48, 72h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 6 days
Irritation parameter:
erythema score
Remarks:
Animal 3
Basis:
mean
Time point:
other: 24, 48, 72h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 8 days
Irritation parameter:
erythema score
Remarks:
Animal 4
Basis:
mean
Time point:
other: 24, 48, 72h
Score:
1.7
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Remarks:
Animal 5
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 5 days
Irritation parameter:
erythema score
Remarks:
Animal 6
Basis:
mean
Time point:
other: 24, 48, 72h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 6 days
Irritation parameter:
edema score
Remarks:
Animal 1
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 4 days
Irritation parameter:
edema score
Remarks:
Animal 2
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Remarks:
Animal 3
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
edema score
Remarks:
Animal 4
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Remarks:
Animal 5
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
edema score
Remarks:
Animal 6
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
Mean score calculated by average of results at 24h, 48h and 72h for each animal.

Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

 

Score at time point / Reversibility

Erythema

Oedema

Max. score: 2

Max. score: 1

24 h

1/1/1/2/1/1

1/0/1/0/1/0

48 h

1/1/1/2/1/1

1/0/0/0/0/0

72h

1/1/1/1/1/1

1/0/0/0/0/0

Average 24h, 48h, 72h

 1.2/1.2/1

 0.5/0.2/0.2

 Reversibility*)  c  c
 Average time (unit) for reversion  7 days  48h

 

*) Reversibility: c. = completely reversible;= not completely reversible; n. = not reversible

Mortality:

There were no deaths during the study.

Dermal Observations (Table 2):

Very slight to slight erythema and desquamation were noted for all animals. Very slight edema was noted for three animals. All dermal irritation completely subsided

by day 8.

The Primary Irritation Index (PII) was calculated to be 1.4, using the 24-, 48- and 72 -hour observations. The test article, Calcium sulfonate, received a descriptive rating classification of slightly irritating.

TABLE 2
PROJECT NO.WIL-168169 ACUTE DERMAL IRRITATION STUDY IN ALBINO RABBITS                                              
INDIVIDUAL DERMAL SCORES
SITE A: 0.5 ML/SITE
  ERYTHEMA EDEMA
ANIMAL SEX SITE 1H 24H 48H 72H 4D 5D 6D 7D 8D SITE 1H 24H 48H 72H 4D 5D 60 7D 8D
29982 M A 1s 1s 1 1 1 1 0d - - A 0 1 1 1 0 0 0 - -
29983 M A 0s 1s 1 1 1 1 0d - - A 0 0 0 0 0 0 0 - -
29984 M A 0s 1s 1 1d 1d 1d 1d 1d 0 A 0 1 0 0 0 0 0 0 0
29993 F A 1 2 2 1d 1d 1d 1d 0d - A 0 0 0 0 0 0 0 0 -
29994 F A 1 1 1 1d 1d 0d - - - A 1 1 0 0 0 0 - - -
29995 F A 1 1 1 1 1 1d 0d - - A 0 0 0 0 0 0 0 - -
    TOTAL 4 7 7 6 6 5 2 1 0 TOTAL 1 3 1 1 0 0 0 0 0
PII calculated using test periods: 24h, 48h, 72 h
Primary Irritaton Index (PII) = [(7+7+6)/18] + [(3+1+1)/18]
(PII) = [20/18] + [5/18]
(PII) = 1.1 + 0.3
PII  = 1.4 = SLIGHTLY IRRITATING
PII calculated using test periods: 24h, 72 h
Primary Irritaton Index (PII) = [(7+6)/12] + [(3+1)/12]
(PII) = [13/12] + [4/12]
(PII) = 1.1 + 0.3
PII  = 1.4 = SLIGHTLY IRRITATING
 
H = HOURS     
 D = DAYS 
F = FEMALE
M = MALE 
d = DESQUAMATION  
s = DOSE SITE STAINED YELLOW
 - = DERMAL IRRITATION PREVIOUSLY SUBSIDED; ANIMAL TERMINED FROM STUDY

Body Weights (Table 3):

There were no remarkable body weight changes during the study.

Table 3
Acute Dermal Irritation Study of Calcium sulfonate in Albino Rabbits
Individual Body Weights (Grams)
Initiation Termination
Group Number Sex (Day 0) (Interval)
0.5 ml/site 29982 M 2480 2693 (Day 6)
29983 M 2218 2320 (Day 6)
29984 M 2329 2504 (Day 8)
29993 F 2071 2294 (Day 7)
29994 F 2213 2507 (Day 5)
29995 F 2311 2596 (Day 6)
M = Male
F = Female
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: EU-GHS
Conclusions:
Mean scores for each animal at 24h, 48h and 72 h for erythema and oedema, respectively, were 0. Therefore, this substance is not irritating to skin under the conditions of this test.
Executive summary:

The primary dermal irritation potential of Calcium sulfonate was evaluated in this study with New Zealand White rabbits.

There was one group of six young adult albino rabbits that received a single, four-hour, semioccluded exposure. Each 0.5-ml dose of the test article was applied to the clipped, unabraded skin. At completion of exposure, the bandages were removed and the sites washed.

Application sites were evaluated in accordance with the method of Draize at approximately 30-60 minutes and 24,48 and 72 hours after patch removal and daily through day 8, if irritation persisted.

Very slight to slight erythema and desquamation were noted for all animals. Very slight edema was noted for three animals. All dermal irritation completely subsided by day 8.

The Primary Irritation Index (PII) was calculated to be 1.4, using the 24-, 48- and 72 -hour observations. The test article, Calcium sulfonate, received a descriptive rating classification of slightly irritating. The Primary Irritation Index (PII) was 1.4 (24, 48 and 72 hours) and 1.4 (24 and 72 hours).

This is however, not considered to be irritating taking into account the classification criteria for skin irritation by the european global harmonised system (a dermal irritant is a substance which causes a primary irritation index of >2.3 < 4).

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

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Between 21 May 1992 and 11 June 1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted in compliance with agreed protocols/ standard guideline and to GLP standards, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.
Qualifier:
equivalent or similar to
Guideline:
other: U.S. Federal Hazardous Substances Act (16 CFR 1500)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Young adult animals were acclimated for at least one day before use. The animals were housed individually in suspended wire mesh cages, were supplied Purina Laboratory Chow or a the comparable diet and tap water ad libitum, and were maintained on a 12 hour light and 12 hour dark cycle. A cage card was used to identify each animal.
Vehicle:
unchanged (no vehicle)
Controls:
other: The untreated eye served as the control.
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
Test material was instilled into one eye of the test animal while the other eye remained untreated to serve as a control. The test material was not washed from the eyes.
Observation period (in vivo):
24, 48, and 72 hours
Number of animals or in vitro replicates:
6
Details on study design:
A dose of 0.1 ml of the test material was instilled in one eye of each animal. The other eye served as the control. The eyes of each animal were observed at 24, 48, and 72 hours according to the method of Draize.
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: No effects were noted.
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
2
Reversibility:
other: No effects were noted.
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, and 72 hours
Score:
0.39
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, and 72 hours
Score:
0.45
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: EU-GHS
Conclusions:
In accordance with EU CLP Regulation (EC) No. 1272/2008 this substance is not classified as an eye irritant.
Executive summary:

The eye irritation potential of Magnesium sulfonate was evaluated using a modified procedure of the basic criteria established by the U.S. Federal Hazardous Substances Control Act (16 CFR 1500). A group of six albino rabbits was used for the study. Each animal received a single, unwashed exposure of 0.1 ml of the test article instilled into one eye. The other eye served as a control. Animals were observed at 24, 48, 72 hours in accordance with the method of Draize. Mean 24, 48, and 72 hour corneal, iris and conjunctival erythema and chemosis scores were 0, 0, 0.39 and 0.45, respectively. Based on these results this substance is not classified as an eye irritant in accordance with EU CLP Regulation (EC) No. 1272/2008.

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Between 7 October 1999 and 16 October 1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted in compliance with agreed protocols/ OECD Guideline and to GLP standards, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Young adult animals weighing 2222 to 2515 grams were identified with eartags. the animals were housed in individual suspended wire mesh cages and acclimated for a minimum of 7 days. They were offered approximately 150 g of PMI Nutrition International inc. Certified Rabbit LabDiet(R) 5322 per day and given Municipla water ad libitum. Animal rooms were controlled at 68.3-68.8 deg F, 30.2-55.0% humidity and 12 hour light/12 hour dark cycles.
Vehicle:
unchanged (no vehicle)
Controls:
other: One eye was use for the test substance; the other served as the control.
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
Test material was instilled into one eye of the test animal while the other eye remained untreated to serve as a control. The test material was not washed from the eyes.
Observation period (in vivo):
1, 24, 48, 72 hours and day 4 when no irritation was observed
Number of animals or in vitro replicates:
6
Details on study design:
A group of six albino rabbits was used for the study. Each animal received a single, unwashed exposure of 0.1 ml of the test article instilled into the lower conjunctival sac of the right eye. The eyelid was held closed for approximately one second and released. The left eye was manipulated in a similar manner as the right eye and served as a contralateral control. Mortality checks were conducted twice daily and body weights were recorded at day 0 and termination. Animals were observed at 1, 24, 48, 72 hours and through day 4 for eye irritation in accordance with the method of Draize.
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 Hours
Score:
0
Max. score:
4
Reversibility:
other: No corneal effects noted
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 Hours
Score:
0
Max. score:
2
Reversibility:
other: No iridial effects observed
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 Hours
Score:
0.95
Max. score:
3
Reversibility:
fully reversible within: day 4
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 Hours
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Other effects:
No mortality or effects on body weight were observed.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: EU-GHS
Conclusions:
In accordance with EU CLP Regulation (EC) No. 1272/2008 this substance is not classified as an eye irritant.
Executive summary:

The eye irritation potential of Magnesium sulfonate was evaluated in accordance with OECD Guideline 405. A group of six albino rabbits was used for the study. Each animal received a single, unwashed exposure of 0.1 ml of the test article instilled into the lower conjunctival sac of the right eye. The eyelid was held closed for approximately one second and released. The left eye was manipulated in a similar manner as the right eye and served as a contralateral control. Mortality checks were conducted twice daily and body weights were recorded at day 0 and termination. Animals were observed at 1, 24, 48, 72 hours and through day 4 for eye irritation in accordance with the method of Draize. No mortality or effects on body weight were observed. Mean 24, 48, and 72 hour corneal, iris and conjunctival erythema and chemosis scores were 0, 0, 0.95 and 0.33, respectively. Based on these results this substance is not classified as an eye irritant in accordance with EU CLP Regulation (EC) No. 1272/2008.

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
Between 28 February 1972 and 21 March 1972
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Study not conducted to Guidelines or to GLP.
Qualifier:
no guideline followed
Principles of method if other than guideline:
Adult New Zealand white rabbits (3/sex) were administered 0.1 ml of test substance into one eye. The other eye served as a control. Eyes were scored for corneal, iritis and conjunctival effects 24, 48 and 72 hours following exposure.
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml

Observation period (in vivo):
24, 48 and 72 hours following dosing.
Number of animals or in vitro replicates:
3 male/3 female
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): unwashed exposure

SCORING SYSTEM: Draize


TOOL USED TO ASSESS SCORE: ophthalmoscope/ fluorescein
Irritation parameter:
cornea opacity score
Remarks:
Animal 1
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Remarks:
Animal 2
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Remarks:
Animal 3
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Remarks:
Animal 4
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Remarks:
Animal 5
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Remarks:
Animal 6
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
0
Irritation parameter:
iris score
Remarks:
Animal 1
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
0
Irritation parameter:
iris score
Remarks:
Animal 2
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
0
Irritation parameter:
iris score
Remarks:
Animal 3
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
0
Irritation parameter:
iris score
Remarks:
Animal 4
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
0
Irritation parameter:
iris score
Remarks:
Animal 6
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Remarks:
Animal 1
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Remarks:
Animal 2
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Remarks:
Animal 3
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
1.3
Max. score:
2
Irritation parameter:
conjunctivae score
Remarks:
Animal 4
Basis:
mean
Time point:
other: 24, 48, 72 hour
Score:
1.3
Max. score:
2
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Remarks:
Animal 5
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Remarks:
Animal 6
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Remarks:
Animal 1
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
chemosis score
Remarks:
Animal 2
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
1.7
Max. score:
2
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
chemosis score
Remarks:
Animal 3
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0.7
Max. score:
2
Reversibility:
fully reversible within: 72 hours
Irritant / corrosive response data:
Chemosis score Animal 4 mean 24, 48, 72 hours, 1, 2 fully reversible within 72 hours
Chemosis score Animal 5 mean 24, 48, 72 hours, 0.3, 1 fully reversible within 48 hours
Chemosis score Animal 6 mean 24, 48, 72 hours, 1, 2 fully reversible within 72 hours
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: EU-GHS
Conclusions:
Mean scores at 24, 48 and 72 hours for each animal for corneal opacity and iritis was 0 for all animals. The scores for conjunctival redness and oedema were less than 2 in 4 animals. Therefore, this substance is not irritating to rabbit eyes.
Executive summary:

In a primary eye irritation study 0.1 ml of the substance was instilled into the conjunctival sac of young adult white rabbits (3/sex).  Animals then were observed for72 hours. Irritation was scored by the method of Draize. No eye irritation was observed.  In this study, the substance is not an eye irritant.

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Study period:
Between 28 December 1990 and 21 February 1991
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conducted to a recognised test guideline but not in compliance with GLP.
Qualifier:
according to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Deviations:
no
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml

Observation period (in vivo):
1, 24, 48 and 72 hours following dosing.
Number of animals or in vitro replicates:
3 male/3 female
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): unwashed exposure

SCORING SYSTEM: Draize


TOOL USED TO ASSESS SCORE: ophthalmoscope/ fluorescein
Irritation parameter:
cornea opacity score
Remarks:
Animal 1, 2, 3, 4, 5, 6
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
0
Irritation parameter:
iris score
Remarks:
Animal 1, 2, 3, 4, 5, 6
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Remarks:
Animal 1 and 6
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Remarks:
Animal 2 and 3
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0.7
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Remarks:
Animals 4 and 5
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Remarks:
Animal 1
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
1.3
Max. score:
2
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Remarks:
Animals 2 and 5
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0.7
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Remarks:
Animal 3
Basis:
mean
Time point:
other: 24, 48, 72 hour
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Remarks:
animal 4
Basis:
mean
Time point:
other: 24, 48, 72 hour
Score:
0.7
Max. score:
2
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Remarks:
Animal 6
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
1.7
Max. score:
2
Reversibility:
not fully reversible within: 72 hours
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: EU-GHS
Conclusions:
Mean scores at 24, 48 and 72 hours for each animal for corneal opacity and iritis was 0 for all animals. Mean scores for all animals for conjunctival redness and oedema was less than 2. Therefore, this substance is not irritating to rabbit eyes.
Executive summary:

In a primary eye irritation study 0.1 ml of the substance was instilled into the conjunctival sac of young adult white rabbits (3/sex).  Animals then were observed for 7 days. Irritation was scored by the method of Draize. No eye irritation was observed.  In this study, the substance is not an eye irritant.

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Study period:
Between 14 October 1999 and 23 October 1999
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study to GLP.
Qualifier:
according to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Covance Research Products
- Age at study initiation: Young adult
- Weight at study initiation: 2141 to 2331 g
- Housing: Individual suspended wire mesh cages
- Diet (e.g. ad libitum): Certified Rabbit Lab diet 150 g/day
- Water (e.g. ad libitum): as libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C
- Humidity (%): 30.2 - 48.5%
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml

Duration of treatment / exposure:
Eyelids of animals were held closed for one second after installation.
Observation period (in vivo):
1, 24, 48 and 72 hours following dosing and on day 4.
Number of animals or in vitro replicates:
3 male/3 female
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): unwashed exposure

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: ophthalmoscope/ fluorescein
Irritation parameter:
cornea opacity score
Remarks:
Animal 1
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Remarks:
Animal 2
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Remarks:
Animal 3
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Remarks:
Animal 4
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Remarks:
Animal 5
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Remarks:
Animal 6
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
0
Irritation parameter:
iris score
Remarks:
Animal 1
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
0
Irritation parameter:
iris score
Remarks:
Animal 2
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
0
Irritation parameter:
iris score
Remarks:
Animal 3
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
0
Irritation parameter:
iris score
Remarks:
Animal 4
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
0
Irritation parameter:
iris score
Remarks:
Animal 6
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Remarks:
Animal 1
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
1.3
Max. score:
2
Reversibility:
fully reversible within: 4 days
Irritation parameter:
conjunctivae score
Remarks:
Animals 2 and 3 and 6
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Remarks:
Animals 4 and 6
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 4 days
Irritation parameter:
chemosis score
Remarks:
Animal 1
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Remarks:
Animal 2
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
1.3
Max. score:
2
Reversibility:
fully reversible within: 4 days
Irritation parameter:
chemosis score
Remarks:
Animal 3
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Remarks:
Animals 4 and 5
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Remarks:
Animal 6
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 4 days
Other effects:
One animal had clear discharge from the eye, one hour post dosing. There were no deaths or changes in bodyweight throughout the study.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: EU-GHS
Conclusions:
Mean scores at 24, 48 and 72 hours for each animal for corneal opacity and iritis was 0 for all animals. Mean scores for conjuntival redness and oedema were less than 2 in all animals. Therefore, this substance is not irritating to rabbit eyes.
Executive summary:

 In a primary eye irritation study 0.1 ml of substance was instilled into the conjunctival sac of young adult white rabbits (3/sex).  Animals then were observed for 7 days. Irritation was scored by the method of Draize. No eye irritation was observed.  In this study, substance is not an eye irritant.

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
disregarded due to major methodological deficiencies
Study period:
Between 13 November 1990 and 16 November 1990
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Insufficient number of animals and duration and not in compliance with GLP.
Qualifier:
according to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Deviations:
yes
Remarks:
2 animals /sex used
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml

Observation period (in vivo):
1, 24, 48 and 72 hours following dosing.
Number of animals or in vitro replicates:
2 male/2 female
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): unwashed exposure

SCORING SYSTEM: Draize


TOOL USED TO ASSESS SCORE: ophthalmoscope/ fluorescein
Irritation parameter:
cornea opacity score
Remarks:
Animal 1
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Remarks:
Animal 2
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
0
Irritation parameter:
iris score
Remarks:
Animal 1
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
0
Irritation parameter:
iris score
Remarks:
Animal 2
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Remarks:
Animal 1
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Remarks:
Animal 2
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
chemosis score
Remarks:
Animal 1
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
chemosis score
Remarks:
Animal 2
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 72 hours
Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: EU-GHS
Conclusions:
Mean scores at 24, 48 and 72 hours for each animal for corneal opacity and iritis was 0 for all animals. Mean scores for 2 animals for conjunctival redness and oedema were 2. Therefore, this substance is irritating to rabbit eyes.
Executive summary:

In a primary eye irritation study 0.1 ml of the substance was instilled into the conjunctival sac of young adult white rabbits (1/sex).  Animals then were observed for 7 days. Irritation was scored by the method of Draize. No eye irritation was observed.  In this study, substance is an eye irritant under the conditions of this test.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation:

A key study was undertaken in 1999 (Kerr, 1999, according to OECD 404) to investigate the skin irritation potential of the magnesium sulfonate target substance, (CAS 231297-75-9), in New Zealand White rabbits. A group of 6 animals were acclimated for a minimum of 7 days. A dose of 0.5 ml then was applied to a shaved, unabraded site on each animal. A semi-occlusive wrapping was applied to hold the test material in place. At the end of 4 hours, the wrapping was removed and the site was wiped with a disposable towel moistened with deionized water to remove the test material. The test sites were then evaluated in accordance with the method of Draize at approximately 30-60 minutes, 24, 48 and 72 hours and daily through day 13 if irritation persisted. Animals were observed twice daily for mortality, and body weights were recorded at day 0 and at termination. Mean erythema scores at 24, 48 and 72 hours were 1.83, 1.67, and 1.83, respectively and were fully reversible by day 13. Mean oedema scores at 24, 48 and 72 hours were 0.17, 0, and 0, respectively and were fully reversible by 48 hours. No mortality or effects on body weight were observed. Based on the results of this study this substance is not classified as a skin irritant in accordance with EU CLP Regulation (EC) No. 1272/2008.

Additional supporting data on calcium sulfonate read-across substances in rabbits also show that these substances are also not considered to be irritating to the skin.

In one supporting study with the calcium sulfonate read across substance CAS 70024-69-0 (Hoff, 2002a), New Zealand White rabbits (3 animals) were treated semi-occlusively (type of cover: plastic) with 0.5 ml of the test material for 4 hours. After removal of the substance (gently washing with distilled water) the animals were observed for 14 days. The test sites were then evaluated in accordance with the method of Draize at 24, 48 and 72 hours and then daily if irritation persisted. The mean erythema score were 0.7, 0 and 1.7, and were fully reversible by 72 hours or 14 days for 1.7. Mean oedema scores at 24, 48 and 72 hours were 0, 0 and 1, and were fully reversible within 14 days. Animals did not display any abnormal signs throughout the test period. Bodyweights did not significantly alter. Based on the results of this study this substance is not classified as a skin irritant in accordance with EU CLP Regulation (EC) No. 1272/2008.

In another supporting study the same calcium sulfonate read across substance CAS 70024-69-0 (Hoff, 2002b), was investigated in young adult New Zealand White rabbits (3 animals) were treated semi-occlusively (shaved skin) with 0.5 ml of the test material for 4 hours. After removal of the substance (gently washing with distilled water) the animals were observed for 7 days. The test sites were then evaluated in accordance with the method of Draize at 24, 48 and 72 hours and then daily if irritation persisted. The mean erythema score were 1, 1 and 2, and were fully reversible within 7 days for 1.7. Mean oedema scores at 24, 48 and 72 hours were 0, 0 and 1.3, and were fully reversible within 7 days. Animals did not display any abnormal signs throughout the test period. Bodyweight was reduced in one animal. Based on the results of this study this substance is not classified as a skin irritant in accordance with EU CLP Regulation (EC) No. 1272/2008.

In a supporting skin irritation screening study (Buehler, 1990a) the calcium sulfonate read across substance, CAS 70024-69-0 was investigated in 2 rabbits (1 male and 1 female). A dose of 0.5 ml of the test material was placed on gauze, which was applied to the shaved skin and then covered with a semi-occlusive wrap. After 4 hours the wrap and gauze were removed and the skin of each animal was evlauated at 24 and 72 hours in accordance with the method of Draize. The mean erythema score were 2,5 in one animal and 2.0 in the other. In the former animal erythema decreased from a score of 3 at 24 hours to a score of 2 at 72 hours indicating the effects are reversibile. However, because only 2 animals were used and observations were terminated at 72 hours rather than the normal 14 days, this study cannot be used to determine classification and labelling.

In the definitive supporting study of the calcium sulfonate read across substance, CAS 70024-69-0 that was conducted following the screening study of Buehler (1990a), six animals (3 males and 3 female animals( were used to more fully evaluate the skin irritation potential of the calcium sulfonate read across substance, CAS 70024-69-0 (Buehler, 1991b). A dose of 0.5 ml of three different concentrations (6.25 %, 12.5 % and 25 %). the test material was placed on gauze, which was applied to the shaved skin and then covered with a semi-occlusive wrap. After 4 hours the wrap and gauze were removed and the skin of each animal was evlauated at 24 and 72 hours in accordance with the method of Draize. The mean erythema score for 6.25 % were 1.5, 2, 2, 2, 2 and 1, and were not fully reversible within 72 hours. Mean oedema scores for 6.25 % at 24 and 72 hours were 0.5, 0.5, 0, 2, 0.5 and 1, and were mainly not fully reversible within 72 hours. The mean erythema score for 12.5 % were 1.5, 2, 2, 2, 2.5 and 2, and were not fully reversible within 72 hours. Mean oedema scores for 6.25 % at 24 and 72 hours were 0.5, 0.5, 0.5, 1, 1.5 and 0.5, and were mainly not fully reversible within 72 hours. The mean erythema score for 25 % were 2, 3, 3, 2.5, 2 and 2, and were not fully reversible within 72 hours. Mean oedema scores for 25 % at 24 and 72 hours were 2, 2.5, 1.5, 2.5, 0.5 and 2, and were mainly not fully reversible within 72 hours. Mean scores for each animal at 24h, and 72 h for erythema and oedema, respectively, were less than 2.3. Therefore, this substance is not irritating to skin under the conditions of this test.

In an additional supporting study with the same calcium read across substance, CAS 70024-69-0 (Swan, 1972), the same calcium sulfonate read across substance was applied to two areas of the backs and flanks of 6 albino rabbits. 0.5 ml of test substance was applied to the sites (one abraded, one intact) and covered with a gauze patch. The substance was applied for 24 hours, before scoring for oedema and erythema was undertaken. Scoring was also performed after 72 hours. The mean erythema score were 0. Mean oedema scores at 24 and 72 hours were 0 as well. Based on the results of this study this substance is not classified as a skin irritant in accordance with EU CLP Regulation (EC) No. 1272/2008.

Finally in another supporting study with the same calcium sulfonate read across substance, CAS 70024-69-0 (Kern, 1999) was investigated for its irritating potential in rabbits. New Zealand White rabbits (3 males and 3 females) were treated semi-occlusively (type of cover: gauze binder) with 0.5 ml of the test material for 4 hours. After removal of the substance the animals were observed for 8 days. The test sites were then evaluated in accordance with the method of Draize at 60 min, 24, 48 and 72 hours and then daily if irritation persisted. The mean erythema score were 1, 1, 1, 1.7, 1 and 1, and were fully reversible by maximally 8 days. Mean oedema scores at 24, 48 and 72 hours were 1, 0, 0.3, 0, 0.3 and 0, and were fully reversible within 48 h or 4 days. Animals did not display any abnormal signs throughout the test period. Bodyweights did not significantly alter.

In accordance with EU CLP (Regulation (EC) No. 1272/2008) classification of this substance is not required for skin irritation.

Eye irritation:

In a key study, the eye irritation potential of the magnesium sulfonate target substance, (CAS 231297-75-9), was evaluated in accordance with OECD 405 (Kern,1999b). A group of six albino rabbits was used for the study. Each animal received a single, unwashed exposure of 0.1 ml of the test article instilled into the lower conjunctival sac of the right eye. The eyelid was held closed for approximately one second and released. The left eye was manipulated in a similar manner as the right eye and served as a contralateral control. Mortality checks were conducted twice daily and body weights were recorded at day 0 and termination. Animals were observed at 1, 24, 48, 72 hours and through day 4 for eye irritation in accordance with the method of Draize. No mortality or effects on body weight were observed. Mean 24, 48, and 72 hour corneal, iris and conjunctival erythema and chemosis scores were 0.0, 0.95 and 0.33, respectively. Based on these results this substance is not classified as an eye irritant in accordance with EU CLP Regulation (EC) No. 1272/2008.

Another key study also evaluated the eye irritation potential of the magnesium sulfonate target substance, (CAS 231297-75-9), using a modified procedure of the basic criteria established by the U.S. Federal Hazardous Substances Control Act (16 CFR 1500, Buehler, 1992). A group of six albino rabbits was used for the study. Each animal received a single, unwashed exposure of 0.1 ml of the test article instilled into one eye. The other eye served as a control. The test material was not washed from the eyes. Animals were observed at 24, 48, 72 hours in accordance with the method of Draize. Mean 24, 48, and 72 hour corneal, iris and conjunctival erythema and chemosis scores were 0, 0, 0.39 and 0.45, respectively. Based on these results this substance is not classified as an eye irritant in accordance with EU CLP Regulation (EC) No. 1272/2008.

A number of other eye irritation studies on calcium sulfonate read-across substances in rabbits also show that these substances are not irritating to the eyes.

In a supporting eye irritation screening study (Buehler, 1990b) the calcium sulfonate read across substance, CAS 70024-69-0 was investigated in 2 rabbits (1 male and 1 female). Each animal received a single, exposure of 0.1 ml of the test article instilled into one eye. The other eye served as a control. The test material was not washed from the eyes. Animals were observed at 1, 24, 48, 72 hours in accordance with the method of Draize. Mean scores at 24, 48 and 72 hours for each animal for corneal opacity and iritis were 0 for all animals. Mean scores for conjunctival redness was 2 in both animals. Conjunctival oedema scores were 2.0 in one animal and 2.33 for the other. In the latter animal the conjunctival oedema decreased from a score of 3 at 24 hours to a score of 2 at 72 hours indicating the effects beeing reversibile. However, because only 2 animals were used and observations were terminated at 72 hours rather than the normal 21 days, this study cannot be used to determine classification and labelling.

In the definitive supporting study of the calcium sulfonate read across substance, CAS 70024-69-0 that was conducted following the screening study of Buehler (1990b), six animals (3 males and 3 female animals) were used to more fully evaluate the eye irritation potential of the calcium sulfonate read across substance, CAS 70024-69-0 (Buehler, 1991b). Each animal received a single, exposure of 0.1 ml of the test article instilled into one eye. The other eye served as a control. The test material was not washed from the eyes. Animals were observed at 1, 24, 48, 72 hours in accordance with the method of Draize. Mean scores at 24, 48 and 72 hours for each animal for corneal opacity and iritis was 0 for all animals. Mean scores for conjunctival redness were 1, 0.7, 0.7, 0.3, 0.3 and 1, respectively. Mean scores for chemosis were 1.3, 0.7, 0, 0.7, 0.7 and 1.7, respectively. With the exception of the 1.7 value for chemosis in animal 6, all other signs were fully reversible within 72 hours. The mean scores for all animals for conjunctival redness and oedema were less than 2. Therefore, this substance is not irritating to rabbit eyes.

In another supporting study (Swan, 1972) the calcium sulfonate read across substance, CAS 70024-69-0 was investigated in rabbits. Adult New Zealand white rabbits (3/sex) were administered 0.1 ml of test substance into one eye. The other eye served as a control. The test material was not washed from the eyes. Animals were observed at 24, 48, 72 hours in accordance with the method of Draize. Mean scores at 24, 48 and 72 hours for each animal for corneal opacity and iritis was 0 for all animals. Mean scores for conjunctival redness were 2, 2, 1.3, 1.3, 1 and 1, respectively. Mean scores for chemosis were 2, 1.7, 0.7, 1, 0.3 and 1, respectively. As the scores for conjunctival redness and oedema were less than 2 in 4 animals, therefore, this substance is not irritating to rabbit eyes.

Finally in another supporting study with the calcium sulfonate read across substance, CAS 70024-69-0 (Kern, 1999), investigated the eye irritation potential as well. Adult New Zealand white rabbits (3/sex) were administered 0.1 ml of test substance into one eye. The test material was not washed from the eyes. The other eye served as a control. Eyes were scored for corneal, iritis and conjunctival effects 1, 24, 48 and 72 hours and on day 4 following exposure in accordance with the method of Draize. Mean scores at 24, 48 and 72 hours for each animal for corneal opacity and iritis was 0 for all animals. Mean scores for conjunctival redness were 1.3, 1, 1, 1, 1 and 1, respectively. Mean scores for chemosis were 0.3, 1.3, 0.3, 0, 0 and 1, respectively. One animal had clear discharge from the eye, one hour post dosing. There were no deaths or changes in bodyweight throughout the study. Mean scores for conjuntival redness and oedema were less than 2 in all animals. Therefore, this substance is not irritating to rabbit eyes.

In accordance with EU CLP (regulation (EC) No. 1272/2008), classification of this substance is not required for eye irritation or corrosion.


Justification for selection of skin irritation / corrosion endpoint:
best study available

Justification for selection of eye irritation endpoint:
best study available

Justification for classification or non-classification

In vivo studies with the magnesium sulfonate target substance showed the substance not to be irritating to the skin or the eyes. In addition the calcium sulfonate read across substance (CAS 70024-69-0) was not irritating to the skin or eyes. Therefore, the magnesium sulfonate target substance does not meet the criteria for classification and labelling for skin or eye irritation in accordance with European regulation (EC) No. 1272/2008.