Asphalt, sulfonated, sodium salt

Eye irritation

Administrative data

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

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

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”

Test material

Test material information

Constituent 1

Reference substance name:

Asphalt, sulfonated, sodium salt

EC Number:

269-212-0

EC Name:

Asphalt, sulfonated, sodium salt

Cas Number:

68201-32-1

Molecular formula:

UVCB

IUPAC Name:

Asphalt, sulfonated, sodium salt

Details on test material:

- Name of test material (as cited in study report): Sodium Sulphonated Asphalt
- Molecular formula (if other than submission substance): N/A
- Molecular weight (if other than submission substance): N/A
- Smiles notation (if other than submission substance): N/A
- InChl (if other than submission substance): N/A
- Structural formula attached as image file (if other than submission substance): N/A
- Substance type: active
- Physical state: black solid

Test animals / tissue source

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

Test system

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.

Results and discussion

In vivo

Results

Results 1

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

Results 2

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

Results 3

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

Results 4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

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

Score:

0

Max. score:

10

Results 5

Irritation parameter:

iris score

Basis:

animal #2

Time point:

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

Score:

0

Max. score:

10

Results 6

Irritation parameter:

iris score

Basis:

animal #3

Time point:

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

Score:

0

Max. score:

10

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 1 h

Score:

6

Max. score:

20

Results 8

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 72 h

Score:

0

Max. score:

20

Results 9

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: 1 h

Score:

6

Max. score:

20

Results 10

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: 72 h

Score:

0

Max. score:

20

Results 11

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

other: 1 h

Score:

6

Max. score:

20

Results 12

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

other: 72 h

Score:

2

Max. score:

20

Reversibility:

fully reversible within: 7 d

Results 13

Irritation parameter:

maximum mean total score (MMTS)

Basis:

mean

Score:

6

Max. score:

110

Reversibility:

fully reversible within: 7 d

Results 14

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

Results 15

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

Results 16

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

Results 17

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

Results 18

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

Results 19

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

Results 20

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

Results 21

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

Results 22

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

Results 23

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

Results 24

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

Results 25

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.

Any other information on results incl. tables

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

Applicant's summary and conclusion

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