Tall oil, reaction products with ethanolamine

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

02 December to 09 December 2014

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2015

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Tall oil, reaction products with ethanolamine

IUPAC Name:

Tall oil, reaction products with ethanolamine

Test material form:

semi-solid (amorphous): gel

Details on test material:

- Purity: 100%
- Physical state/Appearance: Brown gel
- Storage Conditions: Room temperature in the dark

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

At the start of the study the animals weighed 2.61 or 2.90 kg and were twelve to twenty weeks old.
Acclimatation period of at least 5 days.
The animals individually housed.
Free access to water and food.
Temperature between 17 and 23°C
Humidity between 30 and 70%
The relative air exchange was at least fifteen changes per hour and the lighting was controlled to give 12 hours continuous light (06.00 to 18.00) and twelve hours darkness.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.5 mL of the test item

Duration of treatment / exposure:

Four hours after application the corset and patches were removed from each animal and any residual test item removed by gentle swabbing with cotton wool soaked in distilled water.

Observation period:

Immediately following removal of patches and approximatively 1, 24, 48 and 72 hours later examination for evidence of primary irritation and scored according to the Draize scoring.

Number of animals:

2 males

Details on study design:

On the back of the rabbit. Product directly applied to the skin under a 2.5 cm x 2.5 cm cotton gauze patch. The patch was secured in position with a strip of surgical adhesive tape. To prevent the animals interfering with the patches the trunk of each rabbit was strapped in an elasticated corset and the animals were returned to their cages for the duration of the exposure period.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

mean score

Time point:

other: 24, 48 and 72 hours

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: 74879 (male)

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

mean score

Time point:

other: 24, 48 and 72 hours

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: 74880 (male)

Results 3

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

mean score

Time point:

other: 24, 48 and 72 hours

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: 74879 (male)

Results 4

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

mean score

Time point:

other: 24, 48 and 72 hours

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Remarks on result:

other: 74880 (male)

Irritant / corrosive response data:

Very slight erythema was noted at one treated skin site immediately after patch removal.
Well-defined erythema and very slight edema were noted at one treated skin site with very slight and very slight edema noted at the other treated skin site 1 hour after patch removal.
Well-defined erythema and very slight edema were noted at both treated skin sites at the 24-Hour observation with very slight erythema, with or without very slight edema, noted at both treated skin site at the 48-Hour observation. Very slight erythema persisted at both treated skin sites at the 72-Hour observation.
Both treated skin sites appeared normal at the 7-Day observation.

Other effects:

The body weight of the animal #74879 increased from 2.61 to 2.80 kg at day 3.
The body weight of the animal #74880 increased from 2.90 to 3.11 kg at day 3.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The skin irritation potential of the teat item was assessed in accordance with OECD Guideline 404. The test item produced a primary irritation index of 1.83 (1.33 for erythema formation and 0.5 for edema formation) and was classified to be mild-irritant to rabbit skin according to the Draize classification scheme but not classified according to EU regulation. No corrosive effects were noted.

Executive summary:

Introduction

The study was performed to assess the irritancy potential of the test item to the skin of the New Zealand White rabbit.

Results

A single 4-Hour, semi-occluded application of the test item to the intact skin of two rabbits produced well-defined erythema and very slight edema. Both treated skin sites appeared normal at the 7-Day observation.

Conclusion

The test item produced a primary irritation index of 1.83 (1.33 for erythema formation and 0.5 for edema formation) and was classified to be mild-irritant to rabbit skin according to the Draize classification scheme but not classified according to EU classification. No corrosive effects were noted.