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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well-described study according to solid protocol. According to GLP. Conclusion only addresses corrosivity, not irritation.
Justification for type of information:
Key study, GLP, Klimisch score 2

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: Department of Transportation Hazardous Materials Regulations of the Code of Federal Regulations, Title 49, section 173.240
Deviations:
not specified
Qualifier:
according to
Guideline:
other: for the scoring: Federal Hazardous Substances Act Grading Code 16 CFR 1500.41
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): "Antioxidant PDA"
- Physical state: purple liquid
- Lot/batch No.: 1549-83
- Storage condition of test material: ambient temperature

Test animals

Species:
rabbit
Strain:
other: New Zealand Albino
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Ray Nichols Rabbitry, Lumberton, Texas
- Age at study initiation: no data
- Weight at study initiation: 2148-2350g
- Housing: individually, in elevated stainless steel cages
- Diet (e.g. ad libitum): Wayne Rabbit Ration, ad libitum
- Water (e.g. ad libitum): city tap water, ad libitum
- Acclimation period: 6 days (quarantine)

ENVIRONMENTAL CONDITIONS
- Temperature (°C): controlled, but no data on actual temperature
- Humidity (%): controlled, but no data on actual humidity
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
0.5 mL of test substance
Duration of treatment / exposure:
4 hours
Observation period:
2 weeks
Number of animals:
6 (3 males, 3 females)
Details on study design:
TEST SITE
24 Hours prior to application of the test article, the fur of the animals was clipped on the dorsal trunk surfaces with an Oster small animal clipper. There was one test site (approximately 5 cm square) per animal within the clipped area. The 5 cm square test site was not abraded. A single application of 0.5 mL of the test article was applied dermally to the 5 cm square prepared site on each animal. The test site was covered with two thicknesses of surgical gauze, 5 cm square, and secured with Coban elastic bandage and Johnson and Johnson Zonas porous adhesive tape. The entire trunk of each animal was wrapped with plastic, 2 mils thick, to retard evaporation of volatile substances and to prevent ingestiont of the test article. In addition, the trunk of each animal was wrapped with a cotton towel, 15 cm x 45 cm, which was secured in place with Johnson and Johnson's Zonas porous adhesive tape.

REMOVAL OF TEST SUBSTANCE
At the end of the 4 hours, the gauze patches were removed. A 30 minute period was allowed for pressure and hydration effects to subside, then the animals were scored. After the 4 hour scoring the test sites were washed with a water moistened cloth towel

SCORING SYSTEM:
Scoring for erythema, eschar formation, and corrosion of the skin according to the Federal Hazardous Substances Act Grading Code at 16 CFR 1500.41

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: 1-6
Time point:
other: 4 hours
Score:
4
Max. score:
4
Remarks on result:
other: 6/6 animals scored 4
Irritation parameter:
erythema score
Basis:
animal: 1-6
Time point:
other: 24 and 48 hours
Score:
3 - 4
Max. score:
4
Remarks on result:
other: 5/6 animals scored 4, 1/6 animal scored 3
Irritation parameter:
erythema score
Basis:
animal: 1-6
Time point:
other: 72 hours and 1 week
Score:
2 - 4
Max. score:
4
Remarks on result:
other: 5/6 animals scored 4, 1/6 animal score 2
Irritation parameter:
erythema score
Basis:
animal: 1-6
Time point:
other: 2 weeks
Score:
0 - 4
Max. score:
4
Remarks on result:
other: 4/6 animals scored 4, 2 animals scored 0
Irritation parameter:
edema score
Basis:
animal: 1-6
Time point:
other: 4 and 24 hours
Score:
4
Max. score:
4
Remarks on result:
other: 6/6 animals scored 4
Irritation parameter:
edema score
Basis:
animal: 1-6
Time point:
other: 48 hours
Score:
1 - 2
Max. score:
4
Remarks on result:
other: 3/6 animals scored 2, 3/6 animals scored 1
Irritation parameter:
edema score
Basis:
animal: 1-6
Time point:
other: 72 hours
Score:
0 - 2
Max. score:
4
Remarks on result:
other: 2/6 animals scored 2, 3/6 animals scored 1, 1/6 animal scored 9
Irritation parameter:
edema score
Basis:
animal: 1-6
Time point:
other: 1 week
Score:
0 - 2
Max. score:
4
Remarks on result:
other: 3/6 animals scored 2, 2/6 animals scored 1, 1/6 animal scored 0
Irritation parameter:
edema score
Basis:
animal: 1-6
Time point:
other: 2 weeks
Score:
0 - 1
Max. score:
4
Remarks on result:
other: 4/6 animals scored 1, 2/6 animals scored 0

Any other information on results incl. tables

Gross observations of corrosion were noted in 2/6 rabbits at the 1 week reading and 4/6 rabbits at the 2 week reading.

A corrosive material is defined as one that causes alteration or tissue destruction to the intact skin on an albino rabbit after an exposure period of 4 hours or less. Tissue destruction is considered to have occurred if ulceration or necrosis is noted at the 4 hour, 24 hour or 48 reading.

Therefore, Antioxidant PDA sample No. 1549 -83 is not considered to be a corrosive material when applied to the intact skin of albino rabbits by the method described in the Department of Transportation Hazardous Materials Regulation of the Code of Federal Regulations, Title 49, section 173.240

Applicant's summary and conclusion

Interpretation of results:
Category 1C (corrosive)
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Gross observations of corrosion were noted in 2/6 rabbits at the 1 week reading and 4/6 rabbits at the 2 week reading. Antioxidant PDA sample No. 1549 -83 is 1) not considered to be a corrosive material when applied to the intact skin of albino rabbits by the method described in the Department of Transportation Hazardous Materials Regulation of the Code of Federal Regulations, Title 49, section 173.240 2) classified as a skin corrosive Cat. 1C according to the CLP regulation (EC 1272/2008)