Registration Dossier

Administrative data

Description of key information

The skin irritation profile of benzene, mono-C10-13-alkyl derivatives, distillation residues, sulfonated, sodium salt (registered/target substance) was determined in an in vitro corrosivity (OECD 439) and skin irritation (OECD 435) assays. An in vivo rabbit study (OECD 404) on a read across substance confirmed these skin irritation results. The eye irritation profile of the registered/target substance was not determined by eye toxicity studies. Instead, read across substances were used to predict the eye irritation of the registered substance.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation / corrosion
Remarks:
in vitro
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Experimental Data: 19 Jan 2016 (Preliminary Data Collected 06 Jan 2016)
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study completed according to OECD 435 Guidelines, and under GLP.
Qualifier:
according to
Guideline:
OECD Guideline 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion)
GLP compliance:
yes (incl. certificate)
Test system:
other: Bovine Cornea
Source species:
other: Cow
Cell type:
other: Cornea
Cell source:
other:
Species:
other: N/A - Macromolecular Barrier
Type of coverage:
other: In vitro
Duration of treatment / exposure:
Single Exposure
Irritation / corrosion parameter:
penetration time (in minutes)
Value:
> 70.25
Vehicle controls validity:
valid
Negative controls validity:
valid
Remarks:
Citric acid
Positive controls validity:
valid
Remarks:
1.0 N Sodium hydroxide
Remarks on result:
no indication of irritation
Remarks:
Non Corrosive

The positive control, 1.0 N Sodium Hydroxide, was categorized as received and the negative control, Citric Acid, was used as a 10% solution in water. The results of both controls were considered valid.

Interpretation of results:
other: Non-corrosive
Remarks:
Criteria used for interpretation of results: OECD GHS
Conclusions:
The material was considered non-corrosive.
Executive summary:

Benzene, mono-C10 -13 -alkyl derivatives, distillation residues, sulfonated, sodium salts was determined to be compatible with the Corrositex system. Then, a formulation of 10% test material in water 100 uL test material : 900 uL tissue culture water) was categorized by pH to determine Category 2 cut-off times should be used to determine corrosivity. 0.5 mL of the test article was added to each of four Corrositex® test vials containing biobarriers and the times required for the test article to permeate or destroy the biobarriers were recorded. A positive control (1.0 N sodium hydroxide) and a negative control (1% citric acid) were tested concurrently. The average breakthrough time for the four test material samples was >70.25 minutes. The test material was considered non-corrosive.

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2 Jan to 5 Jan 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study completed according to OECD 439 Guidelines, and under GLP.
Qualifier:
according to
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
Version / remarks:
OECD Guideline 439 (In Vitro Skin Irritation)
Deviations:
no
Principles of method if other than guideline:
OECD Guideline 439 (In Vitro Skin Irritation)
GLP compliance:
yes (incl. certificate)
Species:
human
Vehicle:
other: vehicle
Controls:
yes, concurrent vehicle
Amount / concentration applied:
30 uL
Duration of treatment / exposure:
60 minutes
Observation period:
24 hours
Details on study design:
To predict dermal irritation potential, MatTek EpiDerm tissue samples were treated with 30 μl of Benzene, mono-C10-13-alkyl derivatives, distillation residues, sulfonated, sodium salts, 30 μl of phosphate buffered saline [PBS] (negative control), or 5% sodium dodecyl sulfate [SDS] solution (positive control). A nylon mesh was placed on top to facilitate even distribution of the materials and each test was conducted in triplicate. The dosed tissues were placed in an incubator for 35±1 minutes, then moved back to the sterile hood for the remainder of 60 minutes. Tissues were then rinsed with PBS, blotted and dried, and transferred to fresh medium.The tissues were returned to the incubator for an additional 42 hours with media changed at 24 hours. The samples were then incubated for 3 hours in 300 μl Methyl thiazole tetrazolium (MTT) solution (1 mg/ml MTT in DMEM) followed by 2 hours at room temperature in 2.0 mL extractant solution (isopropanol). Two aliquots of the extracted MTT were then measured at 540 nm to determine viability.
Irritation / corrosion parameter:
other: other: % Mean Tissue Viability
Value:
3
Remarks on result:
other:
Remarks:
Basis: mean. Time point: 60 minutes exposure; 48 hours post-incubation. Max. score: 4.1. Reversibility: other: Not applicable. Remarks: Benzene mono-C10-13-alkyl derivatives, distillation residues, sulfonated, sodium salts. (migrated information)
Irritation / corrosion parameter:
other: other: % Mean Tissue Viability
Value:
100
Remarks on result:
other:
Remarks:
Basis: mean. Time point: 60 minutes exposure; 48 hours post-incubation. Max. score: 109.3. Reversibility: other: Not applicable. Remarks: PBS (Negative Control). (migrated information)
Irritation / corrosion parameter:
other: other: % Mean Tissue Viability
Value:
2.2
Remarks on result:
other:
Remarks:
Basis: mean. Time point: 60 minutes exposure; 48 hours post-incubation. Max. score: 2.5. Reversibility: other: Not applicable. Remarks: 5% Sodium Dodecyl Sulfate (positive Control). (migrated information)
Irritant / corrosive response data:
If the mean tissue viability was ≤50%, the test material was classified as an irritant; if the mean tissue viability was >50%, the test material was classified as a non-irritant

Test and Control Article Identity

% Mean Tissue Viability

Irritancy Classification

Benzene, mono-C10-13-alkyl derivatives, distillationresidues, sulfonated, sodium salts; Lot/Batch# RS-873-4-2

3.0

Irritant

Phosphate-Buffered Saline (Negative Control)

100.0

Non-Irritant

5% Sodium Dodecyl Sulfate (Positive Control)

2.2

Irritant

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
The material was concluded to be an irritant.
Executive summary:

To predict dermal irritation potential, MatTek EpiDerm tissue samples were treated with 30 μl of Benzene, mono-C10-13-alkyl derivatives, distillation residues, sulfonated, sodium salts, 30 μl of phosphate buffered saline [PBS] (negative control), or 5% sodium dodecyl sulfate [SDS] solution (positive control). The samples were then incubated in 300 μl Methyl thiazole tetrazolium (MTT) solution (1 mg/ml MTT in DMEM) followed by 2.0 mL extractant solution (isopropanol). Mean tissue viability was determined to be 3% for the test material, 2.2% for the positive control, and 100% for the negative control. The material was concluded to be an irritant.

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: No report on this study was provided to WRc, therefore this data has not been reviewed. All data provided in this study record was entered by the data owner.
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:
See study report attached.
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
Undiluted material - 0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
6 animals
Details on study design:
See study report attached.
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24-72 hrs
Score:
2.6
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24-72 hrs
Score:
3.3
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24-72 hrs
Score:
6.1
Irritant / corrosive response data:
Moderate-severe to severe erythema and moderate-severe edema reactions. Subcutaneous hemorrhaging, blanching, desquamationa, and possible necrotic areas were also observed. Slight dermal irritation continue to be present at three sites at the Day 14 observation.
Other effects:
See study report attached.
Interpretation of results:
Category 2 (irritant) based on GHS criteria
Remarks:
Migrated information
Conclusions:
Skin Irritant (GHS - Category 2, EU - R38)
Executive summary:
See study report attached.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study and according to GLP. However as this study is used in the context of a read across, Klimisch 2 is assigned.
Justification for type of information:
The sulfonate group is a common functional group present in each of the analogue members, and is expected to exhibit similar biological activities with little influence from the length of carbon chain. Any potential breakdown products, via physical or biological processes, are also expected to result in structurally similar chemicals. In addition, non-random patterns have been observed for the toxicological effects (e.g., available data showed low levels of acute toxicity, lack of mutagenic potential, skin irritating properties and a trend of change in ecotoxicological potential based on molecular weight). These common behaviors and consistent trends suggest a common mechanism and mode of action thereby providing further supporting evidence for the read-across among the linear and branched alkyl benzene sulfonates.
Reason / purpose:
read-across: supporting information
Reason / purpose:
read-across: supporting information
Reason / purpose:
read-across: supporting information
Reason / purpose:
read-across: supporting information
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:
0.3
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Remarks:
Animal 2
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 4 days
Irritation parameter:
conjunctivae score
Remarks:
Animal 3
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Remarks:
Animal 4
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:
Animal 5
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:
Animal 6
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 1, 2, 3
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Remarks:
Animal 4, 5, 6
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 72 hours
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: EU
Conclusions:
Mean scores at 24, 48 and 72 hours for each animal for corneal opacity and iritis was 0 for all animals. Score for conjunctival rednes and oedema werer less than 2 in all of the animals. Therefore, this substance is not irritating to rabbit eyes.
Executive summary:

In a primary eye irritation study 0.1 ml of sodium 4-icosylbenzenesulfonate was instilled into the conjunctival sac of young adultwhite 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, sodium 4-icosylbenzenesulfonate is not an eye irritant.

Endpoint:
eye irritation, other
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study to GLP. However as this study is used in the context of a read across, Klimisch 2 is assigned.
Justification for type of information:
The sulfonate group is a common functional group present in each of the analogue members, and is expected to exhibit similar biological activities with little influence from the length of carbon chain. Any potential breakdown products, via physical or biological processes, are also expected to result in structurally similar chemicals. In addition, non-random patterns have been observed for the toxicological effects (e.g., available data showed low levels of acute toxicity, lack of mutagenic potential, skin irritating properties and a trend of change in ecotoxicological potential based on molecular weight). These common behaviors and consistent trends suggest a common mechanism and mode of action thereby providing further supporting evidence for the read-across among the linear and branched alkyl benzene sulfonates.
Reason / purpose:
read-across source
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 daysENVIRONMENTAL 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 exposureSCORING SYSTEM: DraizeTOOL 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: EU
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 sodium 4-icosylbenzenesulfonate was instilled into the conjunctival sac of young adultwhite 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, sodium 4-icosylbenzenesulfonate is not an eye irritant.

Endpoint:
eye irritation, other
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study. However as this study is used in the context of a read across, Klimisch 2 is assigned.
Justification for type of information:
The sulfonate group is a common functional group present in each of the analogue members, and is expected to exhibit similar biological activities with little influence from the length of carbon chain. Any potential breakdown products, via physical or biological processes, are also expected to result in structurally similar chemicals. In addition, non-random patterns have been observed for the toxicological effects (e.g., available data showed low levels of acute toxicity, lack of mutagenic potential, skin irritating properties and a trend of change in ecotoxicological potential based on molecular weight). These common behaviors and consistent trends suggest a common mechanism and mode of action thereby providing further supporting evidence for the read-across among the linear and branched alkyl benzene sulfonates.
Reason / purpose:
read-across source
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 exposureSCORING SYSTEM: DraizeTOOL 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:
Category 2A (irritating to eyes)
Remarks:
Migrated information Criteria used for interpretation of results: EU
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 sodium 4-icosylbenzenesulfonate 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, sodium 4-icosylbenzenesulfonate is an eye irritant.

Endpoint:
eye irritation, other
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study. However as this study is used in the context of a read across, Klimisch 2 is assigned.
Justification for type of information:
The sulfonate group is a common functional group present in each of the analogue members, and is expected to exhibit similar biological activities with little influence from the length of carbon chain. Any potential breakdown products, via physical or biological processes, are also expected to result in structurally similar chemicals. In addition, non-random patterns have been observed for the toxicological effects (e.g., available data showed low levels of acute toxicity, lack of mutagenic potential, skin irritating properties and a trend of change in ecotoxicological potential based on molecular weight). These common behaviors and consistent trends suggest a common mechanism and mode of action thereby providing further supporting evidence for the read-across among the linear and branched alkyl benzene sulfonates.
Reason / purpose:
read-across source
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 exposureSCORING SYSTEM: DraizeTOOL 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: EU
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 sodium 4-icosylbenzenesulfonatewas 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, sodium 4-icosylbenzenesulfonateis an not eye irritant.

Endpoint:
eye irritation, other
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study not conducted to Guidelines or to GLP. However as this study is used in the context of a read across, Klimisch 2 is assigned.
Justification for type of information:
The sulfonate group is a common functional group present in each of the analogue members, and is expected to exhibit similar biological activities with little influence from the length of carbon chain. Any potential breakdown products, via physical or biological processes, are also expected to result in structurally similar chemicals. In addition, non-random patterns have been observed for the toxicological effects (e.g., available data showed low levels of acute toxicity, lack of mutagenic potential, skin irritating properties and a trend of change in ecotoxicological potential based on molecular weight). These common behaviors and consistent trends suggest a common mechanism and mode of action thereby providing further supporting evidence for the read-across among the linear and branched alkyl benzene sulfonates.
Reason / purpose:
read-across source
Qualifier:
equivalent or similar to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
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 exposureSCORING SYSTEM: DraizeTOOL 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 hours
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 hoursChemosis score Animal 5 mean 24, 48, 72 hours, 0.3, 1 fully reversible within 48 hoursChemosis 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: EU
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 sodium 4-icosylbenzenesulfonatewas instilled into the conjunctival sac of young adultwhite 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, sodium 4-icosylbenzenesulfonate is not an eye irritant.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

SKIN IRRITATION:

Benzene, mono-C10 -13 -alkyl derivatives, distillation residues, sulfonated, sodium salts was determined to be non-corrosive in the Corrositex assay (OECD 439). After confirming the study material is compatible with the assay, a 10% solution of the test material in water was categorized by pH, falling into Category 2. Thus, breakthrough cut-off times of Category 2 were used to determine corrosivity. The test article (0.5 mL) was added to each of four Corrositex® test vials containing macromolecular biobarriers and the times required for the test article to permeate or destroy the biobarriers were recorded. The average breakthrough time for the four test material samples was >70.25 minutes, which exceeds the >60 mins required to be considered non-corrosive. The positive and negative controls (1.0 N sodium hydroxide and 1% citric acid, respectively) were considered valid.

To predict dermal irritation potential, EpiDerm tissue samples were treated with of benzene, mono-C10-13-alkyl derivatives, distillation residues, sulfonated, sodium salts according to OECD 435. The tissue samples were then incubated with methyl thiazole tetrazolium (MTT) solution to assess cell viability. Mean tissue viability was determined to be 3% for the test material, 2.2% for the positive control, and 100% for the negative control. Based on this, benzene, mono-C10-13-alkyl derivatives, distillation residues, sulfonated, sodium salt was concluded to be a skin irritant. These in vitro results are supported by a rabbit study conducted under OECD 404 on the read across substance benzenesulfonic acid, methyl-, monoC20 -24 -branched alkyl derivs., calcium salt (Glaza, 1998).

EYE IRRITATION:

There are no eye irritation studies available on benzene, mono-C10-13-alkyl derivatives, distillation residues, sulfonated, sodium salt, and instead read across substances were used to predict the skin and eye irritation of the registered substance. A summary of these studies are below.

The eye irritation potential of the read across substance calcium sulfonate (CAS 70024-69-0), was evaluated in accordance with EPA OPPTS 870.2400 (Kern, 1999). A group of six albino rabbits (3 per sex) 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. Observations for eye irritation were made at 1, 24, 48 and 72 hours following dosing and on day 4 in accordance with the method of Draize. One animal had clear discharge from the eye, one-hour post dosing. There were no deaths or changes in bodyweight throughout the study. Mean 24, 48, and 72 hour corneal and iris scores were 0 for all animals tested. The conjunctival erythema scores were 1.3, 1, and 1, respectively and were all reversible within 7 days. The chemosis scores were 0.3, 1.3, 0.3, 0, and 1, respectively. In this study, the test substance is not considered an eye irritant.

A second eye irritation study on the read across substance calcium sulfonate (CAS 70024-69-0) (Swan, 1972) administered 0.1 mL of test substance into one eye (the other eye served as a control) of adult New Zealand white rabbits (3/sex). The test material was not washed from the eyes. Eyes were scored for corneal, iritis and conjunctival effects 24, 48 and 72 hours 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 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, this substance is not irritating to rabbit eyes.

In a supporting eye irritation screening study (Buehler, 1990) on the read across substance calcium sulfonate (CAS 70024-69-0) administered to rabbits (1 male and 1 female) 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 being reversible. 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 a definitive supporting study on the read across calcium sulfonate (CAS 70024 -69 -0), that was conducted following the screening study of Buehler (1990), six animals (3 male 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, 1991). 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 read across substance is not irritating to rabbit eyes.


Justification for selection of skin irritation / corrosion endpoint:
To predict dermal irritation potential, MatTek EpiDerm tissue samples were treated with 30 μl of Benzene, mono-C10-13-alkyl derivatives, distillation residues, sulfonated, sodium salts, 30 μl of phosphate buffered saline [PBS] (negative control), or 5% sodium dodecyl sulfate [SDS] solution (positive control). The samples were then incubated in 300 μl Methyl thiazole tetrazolium (MTT) solution (1 mg/ml MTT in DMEM) followed by 2.0 mL extractant solution (isopropanol). Mean tissue viability was determined to be 3% for the test material, 2.2% for the positive control, and 100% for the negative control. The material was concluded to be an irritant.

Justification for selection of eye irritation endpoint:
In a primary eye irritation study 0.1 ml of calcium 4-icosan-3-ylbenzenesulfonate 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, calcium 4-icosan-3-ylbenzenesulfonate is not an eye irritant.

Effects on skin irritation/corrosion: Irritating

Justification for classification or non-classification

In vitro skin corrosion and irritation studies of sufficient quality and tested in accordance with standard methodology (OECD 435 and 439) showed that benzene, mono-C10 -13 -alkyl derivatives, distillation residues, sulfonated, sodium salt was not corrosive but it was irritating to the skin Category 2. This classification was confirmed by an in vivo skin irritation study on a read across substance.

Several eye irritation in vivo studies of sufficient quality on the read across substance calcium sulfonate (CAS 70024-69-0) and conducted in accordance with standard methodology are available. The mean scores in these studies were zero for the cornea and iris. The average scores for conjunctival redness over 24, 48, and 72 hours ranged from 1.0 to 2.0. Overall, mean scores for chemosis and conjunctival redness ranged from 0.3 to 2.0. All adverse effects were fully reversible between 72 hours to 7 days. The cutoff value for eye irritation classification is a positive response of corneal opacity ≥ 3 and/or iritis > 1.5 calculated as the mean scores following grading at 24, 48, and 72 hours after instillation of the test material. Therefore, no classification for eye irritation is proposed for benzene, mono-C10 -13 -alkyl derivatives, distillation residues, sulfonated, sodium salt.