Fatty acids, tall-oil, maleated

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Well documented and reported study fully adequate for assessment. The study was conducted according to internationally accepted technical guidelines and in compliance with GLP in a recognized contract research organization.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Principles of method if other than guideline:

/

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

(9E)-11-(2,5-dioxooxolan-3-yl)octadec-9-enoic acid; (9E,11E)-13-(2,5-dioxooxolan-3-yl)octadeca-9,11-dienoic acid; 8-(7-hexyl-1,3-dioxo-1,3,3a,4,7,7a-hexahydro-2-benzofuran-4-yl)octanoic acid

EC Number:

800-760-0

Cas Number:

68139-89-9

Molecular formula:

Not applicable ( a generic molecular formula cannot be provided for this specific UVCB substance). Molecular weight approximated based on constituents (for the purpose of CHESAR calculations).

IUPAC Name:

(9E)-11-(2,5-dioxooxolan-3-yl)octadec-9-enoic acid; (9E,11E)-13-(2,5-dioxooxolan-3-yl)octadeca-9,11-dienoic acid; 8-(7-hexyl-1,3-dioxo-1,3,3a,4,7,7a-hexahydro-2-benzofuran-4-yl)octanoic acid

Test material form:

other: dark brown liquid

Details on test material:

Substance Name PETASAN
Batch/Lot Number: 1
CAS No.: 68139-89-9
Description: Dark brown liquid
Purity: 100 %
Manufacture Date: 01 December 2013
Expiry Date: 01 December 2015
Storage Condition Room temperature (15-25℃)

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Only animals in acceptable health condition were used for the test. The animals were identified by engraved ear tags. The cages were marked with individual identity cards with information about study code, sex, cage number, dose group and individual animal number. Animals were 12 weeks old, male. Rabbits were individually housed in AAALAC approved metal wire rabbit cages. Cages were of an open wire structure and cages were placed together to allow some social interaction with rabbit(s) in adjoining cages. Temperature 20+-3°C

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

other: no vehicle

Controls:

other: same as test animals

Amount / concentration applied:

0.5 mL on 6 cm2 skin area

Duration of treatment / exposure:

4hours

Observation period:

1, 24, 48 and 72 hours after treatment

Number of animals:

3

Details on study design:

Rabbits were individually housed in AAALAC approved metal wire rabbit cages. Cages were of an open wire structure and cages were placed together to allow some social interaction with rabbit(s) in adjoining cages.
The test item was applied to an approximately 6 cm² area of intact skin as follows:
• A single layer of a fine medical gauze (open-weave with large holes) of approximately 5x5 cm was placed over the application area,
• The appropriate amount of test item was carefully spread over the application area (the gauze helped maintain the test item in place),
• Three more layers of gauze were placed over the test item,
• These gauze patches were kept in contact with the skin by a patch of clear plastic with a surrounding adhesive hypoallergenic plaster to ensure continued good contact between the test item and the shaved skin.
• The entire trunks of the animals were wrapped with plastic wrap for 4 hours.
• Medical elastic tubing was placed over the plastic to keep it in place.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

animal #1

Time point:

other: 1, 24, 48, 72h

Score:

0

Reversibility:

other: not applicable since no irritation

Remarks on result:

other: erythema, oedema

Results 2

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

animal #2

Time point:

other: 1, 24, 48, 72 h

Score:

0

Reversibility:

other: not applicable since no irritation

Remarks on result:

other: erythema, oedema

Results 3

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

animal #3

Time point:

other: 1, 24, 48, 72h

Score:

0

Reversibility:

other: no applicable since no irritation

Remarks on result:

other: erythema, oedema

Irritant / corrosive response data:

no irritation

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

According to Directive 2001/59/EC, PETASAN does not require classification as a skin irritant.
According to the UN Globally Harmonised System of Classification and Labelling of Chemicals, PETASAN does not require classification as a skin irritant.
According to the classification system based on the scheme devised by Draize (1959), PETASAN is a "non-irritant".

Executive summary:

An acute skin irritation study was performed with PETASAN in New Zealand White rabbits. Parameters monitored during this study included mortality, body weight measurements and clinical observations. The irritancy of the test item was evaluated according to the Draize method (OECD No.: 404, 2002). A volume of 0.5 ml test item was applied to the skin of the experimental animals. The test item was applied as a single dose. An adhesive clear plastic patch was applied. The trunk was wrapped in clear plastic with medical tubing used to hold the patch in place. The untreated skin of each animal served as control. After 4 hours, the remaining test item was removed with water at body temperature. To assess skin irritation, animals were examined at 1, 24, 48 and 72 hours after the patch removal. Additional general examinations were performed daily. There was no mortality or systemic clinical changes related to PETASAN administration. There was no effect of treatment on body weight. At observation one, 24, 48 and 72 hours after patch removal, there were no observed clinical signs noted on the skin of the treated animals. As no clinical signs were observed the study was terminated after the 72 hours observation. The animals’ individual mean scores (considering readings at 24, 48 and 72 hours after patch removal) for erythema and oedema were 0.00, 0.00 and 0.00 respectively. According to Directive 2001/59/EC, PETASAN does not require classification as a skin irritant. According to the UN Globally Harmonised System of Classification and Labelling of Chemicals, PETASAN does not require classification as a skin irritant. According to the classification system based on the scheme devised by Draize (1959), PETASAN is a "non-irritant".