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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2005
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to OECD TG 404 and U.S. EPA Health Effects TG, OPPTS 870.2500 and in accordance with the Principles of Good Laboratory Practice (GLP).
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report date:
2005

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
no
Principles of method if other than guideline:
not applicable
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
1,4-bis[(2-ethylhexyl)amino]-5,8-dihydroxy-9,10-dihydroanthracene-9,10-dione
EC Number:
807-717-5
Cas Number:
295800-70-3
Molecular formula:
C30H42N2O4
IUPAC Name:
1,4-bis[(2-ethylhexyl)amino]-5,8-dihydroxy-9,10-dihydroanthracene-9,10-dione
Test material form:
other: Blue solid
Details on test material:
- Name of test material (as cited in study report): Spectrace MD-8 10 Marker (Solvent Free)
- Physical state: Blue solid
- Lot/batch No.: Lot #RWS-2-43, TD#04-049
- Expiration date of the lot/batch: September 23, 2007
- Stability under test conditions: Test substance was expected to be stable for the duration of testing.
- Storage condition of test material: Stored at room temperature.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Received fiom Robinson Services, Inc. Clemmons, NC on November 10,2004.
- Age at study initiation: Young adult.
- Housing: The animals were singly housed in suspended stainless steel caging with mesh floors which conform to the size recommendations in the most recent Guide for the Care and Use of Laboratory Animals DHEW (NIH).
- Diet (e.g. ad libitum): Pelleted Purina Rabbit Chow #5326
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-22°C
- Photoperiod (hrs dark / hrs light): 12-hour lightfdark cycle

IN-LIFE DATES: From: November 18, 2004 To: November 21, 2004

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): The test substance was moistened with distilled water to achieve a dry paste by preparing a 45% w/w mixture. Five-tenths of a gram of the test substance (1.11 g of the test mixture) was applied to each animal.


Duration of treatment / exposure:
4 hours
Observation period:
The animals were observed for signs of gross toxicity and behavioral changes at least once daily during the test period. Observations included gross evaluation of skin and fur, eyes and mucous membranes, respiratory, circulatory, autonomic and central nervous systems, somatomotor activity and behavior pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhea and coma.
Number of animals:
3 female rabbits
Details on study design:
TEST SITE:
On the day before application, a group of animals was prepared by clipping (Oster model #A5-small) the dorsal area and the trunk. On the day of dosing, but prior to application, the animals were examined for health and the skin checked for any abnormalities. Three healthy animals without preexisting skin irritation were selected for test.
Prior to application, the test substance was moistened with distilled water to achieve a dry paste by preparing a 45% w/w mixture. Five-tenths of a gram of the test substance (1.1 1 g of the test mixture) was placed on a 1-inch x 1-inch, 4-ply gauze pad and applied to one 6-cm2 intact dose site on each animal. The pad and entire trunk of each animal were then wrapped with semi-occlusive 3-inch Micropore tape to avoid dislocation of the pad. Elizabethan collars were placed on each rabbit and they were returned to their designated cages.

REMOVAL OF TEST SUBSTANCE:
After 4 hours of exposure to the test substance, the pads and collars were removed and the test sites were gently cleansed of any residual test substance.

SCORING SYSTEM:
Individual dose sites were scored according to the Draize scoring system (see Table 3) at approximately 1, 24, 48 and 72 hours after patch removal. The Primary Dermal Irritation Index (PDII) was obtained by adding the average erythema and edema scores for the 1, 24, 48 and 72-hour scoring intervals and dividing by the number of evaluation intervals (4).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: 13096
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
other: Mean score for 24, 48 and 72 hr is 0
Irritation parameter:
erythema score
Basis:
animal: 13097
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
other: Mean score for 24, 48 and 72 hr is 0
Irritation parameter:
erythema score
Basis:
animal: 13098
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
other: Mean score for 24, 48 and 72 hr is 0
Irritation parameter:
edema score
Basis:
animal: 13096
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
other: Mean score for 24, 48 and 72 hr is 0
Irritation parameter:
edema score
Basis:
animal: 13097
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
other: Mean score for 24, 48 and 72 hr is 0
Irritation parameter:
edema score
Basis:
animal: 13098
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
other: Mean score for 24, 48 and 72 hr is 0
Irritant / corrosive response data:
Individual Skin Irritation Scores and Mean Score by Time-point
Erythema/Edema Scores
Animal No. Sex Hours After Patch Removal
1 24 48 72
13096 F 1/0 0/0 0/0 0/0
13097 F 1/0 0/0 0/0 0/0
13098 F 1/0 0/0 0/0 0/0
Total 3/0 0/0 0/0 0/0
Mean 1.0/0.0 0.0/0.0 0.0/0.0 0.0/0.0

Any other information on results incl. tables

Erythema/Edema Overall Mean Scores by Animal           

Animal No.

Sex

Hours After Patch Removal

Mean Score for 24, 48 and 72 hour Time-point

24

48

72

13096

F

0/0

0/0

0/0

0/0

13097

F

0/0

0/0

0/0

0/0

13098

F

0/0

0/0

0/0

0/0

SUMMARY OF PRIMARY SKIN IRRITATION SCORES1

 

Hours

 

1

24

48

72

Erythema

1.0

0

0

0

Edema

0

0

0

0

TOTAL (PDI)2

1.0

0

0

0

 

Primary Dermal Irritation Index (PDII): PDI for l, 24, 48 and 72 hours/4= 0.3

 

1Average values for three rabbits.

2PDI = Average Erythema + Average Edema

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: EU GHS
Conclusions:
Under the conditions of this study, Spectrace MD-8 10 Marker (Solvent Free) caused only very slight irritation which was resolved by 24 hrs. Therefore, this material would not be classified as a skin irritant under EU GHS criteria.
Executive summary:

A primary skin irritation test was conducted with rabbits to determine the potential for Spectrace® MD-810 Marker (Solvent

Free) to produce irritation after a single topical application.

Five-tenths of a gram of the test substance was moistened with distilled water and applied to the skin of three healthy rabbits

for 4 hours. Following exposure, dermal irritation was evaluated by the method of Draize et al.

All animals appeared active and healthy. There were no other signs of gross toxicity, adverse pharmacologic effects or abnormal behavior. There was no edema observed at any treated site during this study. One hour after patch removal, all three treated sites

exhibited very slight erythema. All animals were free of dermal irritation by 24 hours. The Primary Dermal Irritation Index (PDII) calculated for this test substance was 0.3.