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Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

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
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
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 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

Test material

Constituent 1
Chemical structure
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

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

Test system

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.

Results and discussion

In vivo

Resultsopen allclose all
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

Any other information on results incl. tables

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.

Applicant's summary and conclusion

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