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Administrative data

Description of key information

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted to guidelines and GLP.
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system 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: EU
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 14 days.  Irritation was scored by the method of Draize.

 

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

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

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study to GLP.
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
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 conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

All available skin irritation and eye irritation data available demonstrate that the substance tested was not

irritating to skin or eyes.

Data are presented only using in vivo methods as these data were available for the substance. In vitro data are

considered not justifiable scientifically or by expense as the data are not likely to provide any additional

contribution to the conclusion available from the in vivo data.

 

Justification for selection of skin irritation / corrosion endpoint:

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 14 days.  Irritation was scored by the method of Draize.

 

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

Justification for selection of eye irritation endpoint:

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.

Justification for classification or non-classification

Based on the data available for skin and eye irritation, exposure to the substance gives rise to no adverse

reactions. The substance is, therefore, considered to be not irritating to skin or eyes.