[No public or meaningful name is available]

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2010

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to valid methods and considered reliable, adequate and relevant, but it was non-GLP and only limited data were provided.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

fatty acids, C16-C18 and C18 unsaturated isopentyl esters, epoxidized

IUPAC Name:

fatty acids, C16-C18 and C18 unsaturated isopentyl esters, epoxidized

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): PLS Green 5; Plastificante A; soiato de isopentila epoxidado- ésteres isopentilicos de ácidos graxos (óleo de soja) epoxidados
- Substance type: Organic UVCB
- Physical state: liquid
- Lot/batch No.:2010-02; No.CPS: 145/2010
- Expiration date of the lot/batch: Shelf life: 2 years
- Other: Production site: Mogi das Cruzes, São Paulo

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: male young healthy adults
- Acclimation period: at least 5 days

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: . The areas not tested on the animal itself, serve as a control

Amount / concentration applied:

0.5 mL

Duration of treatment / exposure:

4 hours

Observation period:

The readings of the skin reactions are carried out in periods of 1, 24, 48, 72 hours and 14 days, as applicable.

Number of animals:

preliminary test: 1
main test: 2

Details on study design:

TEST SITE
- Area of exposure: dorsal thoracic region in an area of approximately 6 cm2
- Type of wrap if used:This area is covered with sterile gauze and secured with the help of hypoallergenic adhesive tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of the exposure period (4 hours), residual test substance is removed using water or appropriate solvent, as necessary.
- Time after start of exposure: 4 hours

SCORING SYSTEM:
Evaluation of Edema formation:
Grade 0: No edema
Grade 1: Very light edema (little perceptive)
Grade 2: Mild edema (border area well-defined and more perceptive)
Grade 3: Moderate edema (increase of approximately 1 mm)
Grade 4: Severe edema (of more than 1 mm increase, including the area higher than the area in contact with the product)

Evaluation of Erythema formation:
Grade 0: Normal skin (usually white in color, can be pink)
Grade 1: Mild erythema (slightly reddened skin where realizes a tint unlike the control area)
Grade 2: Well-defined erythema (the skin becomes red, usually in every area)
Grade 3: Moderate to severe erythema (the skin presents with intense and diffuse redness)
Grade 4: Severe erythema of the skin (the skin presents mild eschar formation -injuries in depth)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

"PLS Green 5" (pH = 5.0) was held in the shaved region on the thoracic back of test animals (pre-test). After exposure of the test substance to the skin of the animal for a period of four hours, slight erythema (grade 1) was observed. However, after 24 hours after the start of the test, the skin presents with normal appearance and coloration featuring the complete reversibility of the observed reactions (grade 0). We also point out that the animal not presented any systemic signs of toxicity during the days of observation. The same pattern of skin reaction was observed in both animals used for the main test and there is also full reversibility of initial erythema observed. Since there were not detected any skin reactions for a period of 72 hours after removal of the semi-occlusive bandages, the test was terminated and the test substance classified as non-irritating.

Any other information on results incl. tables

 Table 1- Values ​​attributed to skin reactions after exposure of the animal to "PLS Green 5" in the pretest.

Cage	Animal	Parameters	4h exposure	1h	24h	48h	72h	14d
1	1	Edema	0	0	0	0	0	-
		Erythema	1	0	0	0	0	-

 

 

Table 2- Values ​​attributed to skin reactions after exposure of the animal to "PLS Green 5" in the main test.

Cage	Animal	Parameters	1h	24h	48h	72h	14d
2	2	Edema	0	0	0	0	-
		Erythema	0	0	0	0	-

 

Table 3- Values ​​attributed to skin reactions after exposure of the animal to "PLS Green 5" in the main test.

Cage	Animal	Parameters	1h	24h	48h	72h	14d
3	3	Edema	0	0	0	0	-
		Erythema	0	0	0	0	-

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

"PLS Green 5" was not irritating to rabbit skin under the conditions of this test.

Executive summary:

PLS Green 5 (Ph = 5.0) was administered in three New Zealand rabbits for 4h on 6 cm2 skin surface by semi-occlusive exposure. Scoring was done after 1h, 24h, 48h, 72h and 14 days for edema and erythema. Values for edema and erythema were 0 in all three annimals up to 72h. In conclusion, PLS Green 5 was not irritating.