Asphalt, sulfonated, sodium salt

Endpoint summary

Description of key information

SKIN IRRITATION: A single 4-hour, semi-occluded application of SAS to the intact skin of three rabbits according to OECD Guideline 404 (Acute Dermal Irritation/Corrosion) and conducted under GLP concluded that SAS did not meet the criteria for classification as irritant according to EU labeling regulations Commission Directive 2001/59/EC or CLP.  

EYE IRRITATION: A single application of SAS to the non-irrigated eye of three rabbits according to OECD Guidelines 404 (Acute Eye Irritation/Corrosion) and conducted under GLP, concluded that SAS did not meet the criteria for classification as irritant according to EU labeling regulations Commission Directive 2001/59/EC or CLP.  

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Reference 1

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2007-12-19 to 2008-01-10

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

purity of the test substance was not supplied

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to other study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

Purity of the test substance was not supplied.

Principles of method if other than guideline:

N/A

GLP compliance:

yes (incl. QA statement)

Remarks:

Certificate from The Department of Health of the Government of the United Kingdom

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan, France
- Age at study initiation: 12-20 weeks
- Weight at study initiation: 2.0-3.5 kg
- Housing: The animals were individually housed in suspended cages.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (deg. C): 17-23; Any occasional deviations from these targets were considered not to have affected the purpose or integrity of the study.
- Humidity (%): 30-70; Any occasional deviations from these targets were considered not to have affected the purpose or integrity of the study.
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: N/A To: N/A

Type of coverage:

semiocclusive

Preparation of test site:

other: clipped on the day before treatment

Vehicle:

other: distilled water

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): N/A


VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 mL was used to moisten the test substance.
- Concentration (if solution): N/A
- Lot/batch no. (if required): N/A
- Purity: N/A

OTHER: On the day of the test a suitable test site was selected on the back of each rabbit. A quantity of 0.5 g of the test substance, moistened with 0.5 mL of distilled water, was introduced.

Duration of treatment / exposure:

4 hours

Observation period:

7 days

Number of animals:

3 rabbits

Details on study design:

TEST SITE
- Area of exposure: Dorsal/flank area (Test substance was introduced under a 2.5 cm x 2.5 cm cotton gauze patch and placed in position. The patch was secured in position with a strip of surgical adhesive tape (approximate size 2.5 cm x 4.0 cm).)
- % coverage: N/A
- Type of wrap if used: The trunk of each rabbit was wrapped in an elasticated corset.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Any residual test substance was removed by gentle swabbing with cotton wool soaked in distilled water.
- Time after start of exposure: 4 hours


SCORING SYSTEM:
-Approx. one hour after the removal of the patches and 24, 48, and 72 h later, the test sites were examined for evidence of primary irritation and scored according to the Draize scale.
- The scores for erythema and oedema (24 and 72 hrs) were totaled for the three test rabbits (12 values) and this total was divided by six to give the primary irritation index of the test substance. See below for scales.
-An additional observation was made on Day 7 to assess the reversibility of skin reactions.

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 24 h

Score:

2

Max. score:

4

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 72 h

Score:

1

Max. score:

4

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 24 h

Score:

1

Max. score:

4

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 72 h

Score:

1

Max. score:

4

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: 24 h

Score:

1

Max. score:

4

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: 72 h

Score:

0

Max. score:

4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: 24 h

Score:

1

Max. score:

4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: 72 h

Score:

0

Max. score:

4

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: 24 h

Score:

0

Max. score:

4

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: 72 h

Score:

0

Max. score:

4

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: 24 h

Score:

0

Max. score:

4

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: 72 h

Score:

0

Max. score:

4

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: Calculated from 24 and 72 hour readings

Score:

1.2

Max. score:

8

Reversibility:

other: There was no irritation noted at 7 days.

Remarks on result:

other: Classification: Mild irritant

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.66

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Very slight erythema was noted at one treated skin site one hour after patch removal with very slight to well-defined erythema noted at all treated skin sites at the 24-hour observation, and very slight erythema was noted at two treated sites at the 48- and 72-hour observations. Very slight oedema was noted at one treated skin site at the 24- and 48-hour observations. Light brown discolouration of the epidermis was noted at one treated skin site at the 48- and 72-hour observations with loss of skin elasticity also noted at the 72-hour observation. Slight desquamation was noted at this treated skin site at the 7-day observation. One treated site appeared normal at the 48-hour observation, and one other treated site appeared normal at the 7-day observation.

Other effects:

N/A

Individual Skin Reactions
Skin Reaction	Observation Time (hrs72)	Individual Scores – Rabbit Number and Sex			Total
		66978 Male	66979 Male	66980 Male
Erythema / Eschar Formation	1	1	0	0	(1)
	24	2	1	1	4
	48	1 Br	1	0	(2)
	72	1 BrLe	1	0	2
	7 days	0 D	0	0	(0)
Oedema Formation	1	0	0	0	(0)
	24	1	0	0	1
	48	1	0	0	(1)
	72	0	0	0	0
	7 days	0	0	0	(0)
( ) = Total values not used for calculation of primary irritation index; Br = light brown discolouration of the epidermis; D = slight desquamation; Le = loss of skin elasticity
Sum of 24- and 72-hour readings (S) : 7
Primary Irritation Index (S/6) : 7/6 = 1.2
Classification : Mild Irritant according to Draize scale

No corrosive effects were noted.

Interpretation of results:

GHS criteria not met

Conclusions:

The test substance produced a primary irritation index of 1.2 and was classified as a mild irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted. However, SAS did not meet the criteria for classification as irritant according to EU labeling regulations Commission Directive 2001/59/EC.

Executive summary:

N/A

Reference 2

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

no data

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Limited methodology was reported

Reason / purpose for cross-reference:

reference to same study

Qualifier:

equivalent or similar to guideline

Guideline:

other: OECD Guideline 430 [In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER) ]

Deviations:

yes

Remarks:

Limited methodology was reported.

Principles of method if other than guideline:

N/A

GLP compliance:

yes (incl. QA statement)

Remarks:

Certificate from The Department of Health of the Government of the United Kingdom

Species:

rat

Strain:

Wistar

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: N/A
- Age at study initiation: N/A
- Weight at study initiation: N/A
- Housing: N/A
- Diet (e.g. ad libitum): N/A
- Water (e.g. ad libitum): N/A
- Acclimation period: N/A


ENVIRONMENTAL CONDITIONS
- Temperature (deg. C): N/A
- Humidity (%): N/A
- Air changes (per hr): N/A
- Photoperiod (hrs dark / hrs light): N/A


IN-LIFE DATES: From: N/A To: N/A

OTHER: Skin discs were obtained from a humanely euthanized young Wistar strain rat.

Type of coverage:

other: not applicable

Preparation of test site:

other: Skin discs were prepared from a humanely euthanized young Wistar rat.

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): N/A
- Concentration (if solution): N/A


VEHICLE
- Amount(s) applied (volume or weight with unit): N/A
- Concentration (if solution): N/A
- Lot/batch no. (if required): N/A
- Purity: N/A

Duration of treatment / exposure:

- The test substance was applied to the epidermal surface of skin discs for a contact period of 24 hours.

Observation period:

none

Number of animals:

three skin discs

Details on study design:

TEST SITE
- Area of exposure: N/A
- % coverage: N/A
- Type of wrap if used: N/A


REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of the contact period the test substance was removed using a jet of warm tap water and analysis was performed.
- Time after start of exposure: 24 hours


SCORING SYSTEM: Corrosive substances produce an irreversible loss of normal stratum corneum integrity and function, this is measured as a reduction in the inherent transcutaneous electrical resistance (TER) assay. Test substances that give a mean electrical resistance of 5K-omega or less are considered likely to be corrosive in vivo. The TER was measured using a low voltage alternating current electronic databridge.

Irritation / corrosion parameter:

transcutaneous electrical resistance (in kΩ)

Value:

14

Vehicle controls validity:

not specified

Negative controls validity:

not specified

Positive controls validity:

not specified

N/A

Interpretation of results:

other: unlikely to be corrosive in vivo

Remarks:

Criteria used for interpretation of results: expert judgment

Conclusions:

- The results of this Transcutaneous Electrical Resistance test indicated that the test substance is unlikely to have the potential to cause corrosion in vivo.

Executive summary:

N/A

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Reference 1

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2008-01-18 to 2008-02-28

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to other study

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

Purity of the test substance was not provided.

Principles of method if other than guideline:

N/A

GLP compliance:

yes (incl. QA statement)

Remarks:

Certificate from “The Department of Health of the Government of the United Kingdom”

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Harlan, France
- Age at study initiation: 12-20 weeks
- Weight at study initiation: 2.0-3.5 kg
- Housing: Animals were housed individually in suspended cages.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (deg. C): The temperature was set to achieve limits of 17-23 deg C. Any occasional deviation from this was considered not to have affected the purpose or integrity of the study.
- Humidity (%): The relative humidity was set to achieve limits of 30-70 %. Any occasional deviation from this was considered not to have affected the purpose or integrity of the study.
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: N/A To: N/A

Vehicle:

unchanged (no vehicle)

Controls:

other: The left eye of each animal served as the control.

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): A volume of 0.1 mL of the test substance, which was found to weigh approximately 97 mg (as measured by gently compacting the required volume into an adapted syringe) was placed into the conjunctival sac of the right eye, formed by gently pulling the lower lid away from the eyeball. The upper and lower eyelids were held together for about one second immediately after treatment, to prevent loss of the test substance, and then released.
- Concentration (if solution): N/A


VEHICLE
- Amount(s) applied (volume or weight with unit): N/A
- Concentration (if solution): N/A
- Lot/batch no. (if required): N/A
- Purity: N/A

Duration of treatment / exposure:

approximately one hour

Observation period (in vivo):

Immediately after the administration of the test substance, an assessment of the initial pain reaction was made. Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment. An additional observation was made, in one treated eye, on Day 7 to assess the reversibility of the ocular effects.

Number of animals or in vitro replicates:

3 animals

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Residual test substance after treatment was flushed from the test eye using 20 mL of distilled water, with the control eye treated in a similar manner.
- Time after start of exposure: ~1 hour


SCORING SYSTEM: Assessment of ocular damage/irritation was done according to the Draize Test. (Draize JH (1977) "Dermal and Eye Toxicity Tests" In: Principles and Procedures for Evaluating the Toxicity of Household Substances, National Academy of Sciences, Washington, DC pp. 48 to 49). Using the numerical data obtained a modified version of the system described by Kay JH and Calandra JC (1962), J. Soc. Cosmet. Chem. 13, 281-289 was used to classify the ocular irritancy potential of the test substance. This was achieved by adding together the scores for the cornea, iris and conjunctivae for each time point for each rabbit. The group means of the total scores for each observation were calculated. The highest of these group means (the maximum group mean score) together with the persistence of the reactions enabled classification of the eye irritancy potential of the test substance. If evidence of irreversible ocular damage was noted, the test substance was classifed as corrosive to the eye.


TOOL USED TO ASSESS SCORE: Examination of the eye was facilitated by the use of the light source from a standard ophthalmoscope.

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: Total score of 1, 24, 48 and 72 h

Score:

0

Max. score:

80

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

other: Total score of 1, 24, 48 and 72 h

Score:

0

Max. score:

80

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

other: Total score of 1, 24, 48 and 72 h

Score:

0

Max. score:

80

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: Total score of 1, 24, 48 and 72 h

Score:

0

Max. score:

10

Irritation parameter:

iris score

Basis:

animal #2

Time point:

other: Total score of 1, 24, 48 and 72 h

Score:

0

Max. score:

10

Irritation parameter:

iris score

Basis:

animal #3

Time point:

other: Total score of 1, 24, 48 and 72 h

Score:

0

Max. score:

10

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 1 h

Score:

6

Max. score:

20

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 72 h

Score:

0

Max. score:

20

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: 1 h

Score:

6

Max. score:

20

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: 72 h

Score:

0

Max. score:

20

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

other: 1 h

Score:

6

Max. score:

20

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

other: 72 h

Score:

2

Max. score:

20

Reversibility:

fully reversible within: 7 d

Irritation parameter:

maximum mean total score (MMTS)

Basis:

mean

Score:

6

Max. score:

110

Reversibility:

fully reversible within: 7 d

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.66

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

- No corneal or iridial effects were noted.
- Minimal conjunctival irritation was noted in all treated eyes one hour after treatment, at the 24 h observation, and persisted in one treated eye at the 48 and 72 h observations.
- Two treated eyes appeared normal at the 48 h observation and the remaining treated eye appeared normal at the 7 day observation.

Other effects:

- Black residual test substance was noted in all treated eyes at the 1 hour observation.
- Light brown-colored staining of the fur was noted around two treated eyes during the study.

The test substance produced minimal conjunctival irritation. Two treated eyes appeared normal at the 48 hour observation and the remaining treated eye appeared normal at the 7 day observation. The test substance produced a maximum group mean score of 6.0 and was classified as a mild irritant (Class 4 on a 1 to 8 scale) according to a modified Kay and Calandra classification system. The test substance did not meet the criteria for classification as irritant according to GHS and CLP classification.

Individual Scores and Individual Total Scores for Ocular Irritation
Rabbit Number and Sex	67066 Male				67101 Male				67102 Male
	IPR = 2				IPR = 2				IPR = 2
Time After Treatment	1 Hour	24 Hours	48 Hours	72 Hours	1 Hour	24 Hours	48 Hours	72 Hours	1 Hour	24 Hours	48 Hours	72 Hours	7 Day
CORNEA
E = Degree of Opacity	0	0	0	0	0	0	0	0	0	0	0	0	0
F = Area of Cornea Involved	0	0	0	0	0	0	0	0	0	0	0	0	0
Score (E x F) x 5	0	0	0	0	0	0	0	0	0	0	0	0	0
IRIS
D	0	0	0	0	0	0	0	0	0	0	0	0	0
Score (D x 5)	0	0	0	0	0	0	0	0	0	0	0	0	0
CONJUNCTIVAE
A = redness	1	1	0	0	1Sf	1Sf	0Sf	0	1Sf	1	1	1	0
B = chemosis	1	0	0	0	1	0	0	0	1	1	0	0	0
C = discharge	1Re	0	0	0	1Re	0	0	0	1Re	1	0	0	0
Score (A x B x C) x 2	6	2	0	0	6	2	0	0	6	6	2	2	0
Total Score	6	2	0	0	6	2	0	0	6	6	2	2	0
IPR = Initial pain reaction
Re = Black residual test material in the treated eye
Sf = Light brown-coloured staining of the fur around the treated eye

.

Individual Total Scores and Group Mean Scored for Ocular Irritation
Rabbit Number and Sex	Individual Total Scores At:
	1 Hour	24 Hours	48 Hours	72 Hours	7 Days
67066 Male	6	2	0	0	-
67101 Male	6	2	0	0	-
67102 Male	6	6	2	2	0
Group Total	18	10	2	2	0
Group Mean Score	6.0	3.3	0.7	0.7	0.0

Interpretation of results:

GHS criteria not met

Conclusions:

The test substance was classified as a mild irritant (class 4 on a 1-8 scale) to the rabbit eye (according to the modified Kay and Chandra Classification System) based on a maximum group mean score of 6.0. However, SAS did not meet the criteria for classification as irritant according to EU labeling regulations Commission Directive 2001/59/EC.

The test material did not meet the criteria for classification as irritant according to EU labelling regulations Commission Directive 2001/59/EC.

Executive summary:

N/A

Reference 2

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

No data

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Remarks:

Test substance purity information was lacking

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to other study

Qualifier:

no guideline available

Principles of method if other than guideline:

The ocular irritancy potential of the test substance was assessed using the Rabbit Enucleated Eye Test (REET). This method involves the application of the test substance onto the cornea of the enucleated eye. The REET is used as the first stage in the assessment of ocular irritancy potential. A negative ocular irritancy potential may require further investigation using an in vivo ocular irritation test. The test has undergone validation and has been shown to reliably detect substances that are negligible, or moderate to severe ocular irritants.

GLP compliance:

not specified

Species:

other: enucleated rabbit eyes

Strain:

other: Enucleated eyes were obtained from the New Zealand White Rabbit and maintained at a temperature of 32+/-1.5 deg C within the superfusion apparatus.

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: N/A
- Age at study initiation: N/A
- Weight at study initiation: N/A
- Housing: N/A
- Diet (e.g. ad libitum): N/A
- Water (e.g. ad libitum): N/A
- Acclimation period: N/A


ENVIRONMENTAL CONDITIONS
- Temperature (deg. C): N/A
- Humidity (%): N/A
- Air changes (per hr): N/A
- Photoperiod (hrs dark / hrs light):N/A


IN-LIFE DATES: From: N/A To: N/A

Vehicle:

unchanged (no vehicle)

Controls:

other: A further two enucleated eyes were treated, for control purposes, with saline solution (0.9% sodium chloride)

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL of the test substance, which was found to weigh approximately 91 mg, was applied onto the cornea of each eye.
- Concentration (if solution): N/A


VEHICLE
- Amount(s) applied (volume or weight with unit): N/A
- Concentration (if solution): N/A
- Lot/batch no. (if required): N/A
- Purity: N/A

Duration of treatment / exposure:

240 minutes

Observation period (in vivo):

- Corneal opacity and corneal epithelium condition were observed at 60, 120, 180 and 240 minutes post-dosing.
- Fluorescein uptake was determined 240 minutes post-dosing.
- Corneal swelling was measured at 60, 120 and 240 minutes post-dosing.

Number of animals or in vitro replicates:

- three enucleated rabbit eyes

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): N/A
- Time after start of exposure: N/A


SCORING SYSTEM: The direct effect of the test substance on the cornea was assessed by evaluation of corneal thickness, corneal opacity, alteration of corneal epithelium and fluorescein uptake. Scoring was performed using the Method for Evaluation of Ocular Irritation by Split-Lamp Biomicroscopic Examination-McDonald-Shadduck Score System. See below for more details.


TOOL USED TO ASSESS SCORE: Slit-lamp biomicroscopic examination

Irritation parameter:

cornea opacity score

Run / experiment:

60, 120, 180 and 240 minutes

Value:

0

Vehicle controls validity:

not specified

Negative controls validity:

not specified

Positive controls validity:

not specified

Irritation parameter:

fluorescein retention score

Run / experiment:

240 minutes

Value:

0

Vehicle controls validity:

not specified

Negative controls validity:

not specified

Positive controls validity:

not specified

Irritation parameter:

percent corneal swelling

Run / experiment:

Test Eyes 60 minutes

Value:

8.1

Irritation parameter:

percent corneal swelling

Run / experiment:

Test Eyes 120 minutes

Value:

6.3

Irritation parameter:

percent corneal swelling

Run / experiment:

Test Eyes 240 minutes

Value:

5.3

Irritation parameter:

percent corneal swelling

Run / experiment:

Control Eyes 60 minutes

Value:

0.6

Irritation parameter:

percent corneal swelling

Run / experiment:

Control Eyes 120 minutes

Value:

0.6

Irritation parameter:

percent corneal swelling

Run / experiment:

Control Eyes 240 minutes

Value:

0.8

Irritant / corrosive response data:

- No corneal cloudiness was observed.
- Corneal epithelium condition was normal at all time points.
- No fluorescein uptake was observed.
- Corneal Swelling-see below

Other effects:

N/A

Corneal Swelling (%) (minutes post-dosing 60 120 240 Test Eyes^a 8.1 6.3 5.3 Control Eyes^b 0.6 0.6 0.8

^aMean of three eyes; ^bMean of two-eyes

Interpretation of results:

other: unlikely to have the potential to cause severe ocular irritancy in vivo

Remarks:

Criteria used for interpretation of results: expert judgment

Conclusions:

The REET results indicated that the test substance was considered unlikely to have the potential to cause severe ocular irritancy in vivo.

Executive summary:

N/A

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

1) Eye irritation: Studies were performed to assess the irritation potential of SAS to the eye of New Zealand White Rabbit. The method met the requirements of OECD Guidelines 405 (Acute Eye Irritation/Corrosion). A single application of SAS to the non-irrigated eye of three rabbits produced minimal conjunctival irritation. Two treated eyes appeared normal at the 48-hr observation and the remaining treated eye appeared normal at the 7-day observation. In addition, the in-vitro study, the Rabbit Enucleated Eye test was performed to assess ocular irritation potential of SAS. A volume of 0.1 mL (91 mg) SAS was applied onto the cornea of each of three enucleated eyes from New Zealand White Rabbits for 60 seconds. Corneal opacity and corneal epithelium condition were observed at 60, 120, 180, and 240 minutes, fluorescein uptake was measured at 240 minutes post-dosing, and corneal swelling was measured at 60, 120 and 240 minutes post-dosing. After 240 minutes, no corneal cloudiness or fluorescein uptake was observed and corneal epithelium condition was normal, indicating that SAS was considered unlikely to have the potential to cause severe ocular irritancy in vivo.

2) Skin Irritation: Studies were performed to assess the irritation potential of SAS to the skin of New Zealand White Rabbit. The method met the requirements of OECD Guideline 404 (Acute Dermal Irritation/Corrosion). A single 4-hr, semi-occluded application of SAS to the intact skin of three rabbits produced very slight to well-defined erythema and very slight oedema. Light brown discoloration of the epidermis, loss of skin elasticity and slight desquamation were also note. In addition, the in-vitro Transcutaneous Electrical Resistance Test (TER) study was also used to assess the skin corrosivity potential of SAS when applied to the epidermal surface of skin discs obtained from young Wistar rats for a contact period of 24 hours, followed by removal using a jet of warm tap water. Based on the results of the TER assay, SAS was considered unlikely to have the potential to cause corrosion in vivo.

Justification for classification or non-classification

Eye irritation: conclusive but not sufficient for classification.

Skin Irritation: conclusive but not sufficient for classification.

Respiratory irritation: Data lacking.