Registration Dossier

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:
2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to OECd TG 404, EPA OPPTS 870.2500 and in accordance with the Principles of Good Laboratory Practice (GLP).
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report Date:
2003

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: dark green crystalline solid
Details on test material:
- Name of test material (as cited in study report): 1,4,5,8-Tetra (4'-n-butylphenylamino) Anthraquinone (TBPAAQ)
- Substance type: dark green crystalline solid
- Physical state: solid
- Analytical purity: > 97% active ingredient
- Lot/batch No.: Lot #020801; TD No. 02-045
- Expiration date of the lot/batch: 31 March 2004
- Stability under test conditions: expected to be stable for the duration of testing
- Storage condition of test material: room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Davidson's Mill Farms, South Brunswick, NJ
- Age at study initiation: young adults
- Housing: singly housed
- Diet (e.g. ad libitum): Pelleted Purina Rabbit Chow #5326 approximately 150 grams daily
- Water (e.g. ad libitum): Filtered tap water was supplied ad-libitum by automatic water dispensing system
- Acclimation period: 11 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 -22°C
- Humidity (%): 46-55%
- Photoperiod (hrs dark / hrs light): 12 hours light/dark cycle

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Remarks:
The test substance was moistened with distilled water to achieve a dry paste by preparing an 80% w/w mixture
Controls:
no
Amount / concentration applied:
Five-tenths of a gram of the active ingredient (0.64 g of the test mixture, after correcting for the percent of active ingredient present and dilution) was applied to one 6 cm2 intact dose site on each animal.
Duration of treatment / exposure:
4 hours
Observation period:
approximately 1,24,48 and 72 hours after patch removal
Number of animals:
3
Details on study design:
Prior to application, the test substance was moistened with distilled water to achieve a dry paste by preparing an 80% w/w mixture. Five-tenths of a gram of the active ingredient (0.64 g of the test mixture, after correcting for the percent of active ingredient present and dilution) was applied to one 6 cm2 intact dose site on each animal and covered with a 1 inch x 1 inch, 4-ply gauze pad. 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. After 4 hours of exposure to the test substance, the pads and collars were removed and the test sites gently wiped with water and a clean towel to remove any residual test substance.
Individual dose sites were scored according to the Draize scoring system at approximately 1, 24, 48 and 72 hours after patch removal.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Irritant / corrosive response data:
The mean erythema and edema scores for all the three rabbits tested across the 24, 48 and 72 hours timepoints were zero.
Other effects:
One hour after patch removal, very slight erythema was noted for all three treated sites and very slight edema was observed at one dose site. All animals were free of dermal irritation within 24 hours.

Any other information on results incl. tables

Individual animal erythema and edema scores

 Animal no. Sex  Hours after patch removal       
     24 48  72 
8626  Male  0/0  0/0  0/0 
8627 Male  0/0  0/0 0/0 
8628  Male  0/0  0/0  0/0 
 Total 0/0 0/0  0/0 
 Mean 0/0  0/0  0/0 

 

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the study, 1,4,5,8-Tetra (4'-n-butylphenylamino) Anthraquinone (TBPAAQ), the mean erythema and edema scores for the 24, 48 and 72 hours post exposure timepoints for all the 3 rabbits tested were 0, hence no classification for skin irritation is necessary.
Executive summary:

A primary skin irritation test was conducted with rabbits to determine the potential for TBPAAQ to produce irritation after a single topical application. Five-tenths of a gram of the active ingredient (approximately 0.64 grams 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.

One hour after patch removal, very slight erythema was noted for all three treated sites and very slight edema was observed at one dose site. All animals were free of dermal irritation within 24 hours. Under the conditions of the study, 1,4,5,8-Tetra (4'-n-butylphenylamino) Anthraquinone (TBPAAQ), the mean erythema and edema scores for the 24, 48 and 72 hours post exposure timepoints for all the 3 rabbits tested were 0, hence no classification for skin irritation is necessary.