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Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
14 November 2016 - 21 November 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report date:
2017

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Tall oil, compd. with triethanolamine
EC Number:
268-453-9
EC Name:
Tall oil, compd. with triethanolamine
Cas Number:
68092-29-5
Molecular formula:
Various
IUPAC Name:
Tall oil, compd. with triethanolamine
Test material form:
liquid: viscous
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Afton Chemical Corporation.
- Lot/batch No. of test material: LAB 4483
- Expiration date of the lot/batch: Manufacture date on CoA is 26 October 2017. Shelf life at ambient temperature is 12 months. Expiry date is not stated in the report. Using the manufacturing date and shelf life, the expiry date is 26th October 2018.
- Purity test date: Not stated

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Ambient temperature
- Stability under test conditions: Stable under the conditions of the test protocol, (private communication sponsor)
- Solubility and stability of the test substance in the solvent/vehicle: Test substance used as received

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: Test substance used as received (unchanged)

OTHER SPECIFICS: none

Test animals

Species:
rabbit
Strain:
New Zealand White
Remarks:
Female, nulliparous and non-pregnant
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Kuiper Rabbitry, Gary, Indiana, USA
- Age at study initiation: Approximately ten to twelve weeks old
- Weight at study initiation: 2.70 to 3.01 kilograms
- Housing: Individually housed in stainless steel cages
- Diet: Purina Laboratory Rabbit Chow ad libitum
- Water: Ad libitum
- Acclimation period: At least five days prior to study initiation

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3° C
- Humidity (%): 30 - 70%
- Air changes (per hr): not stated
- Photoperiod (hrs dark / hrs light): 12 hour light / 12 hours dark cycle

IN-LIFE DATES: From: 14 November 2016 to 21 Novermber 2016

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Remarks:
using electrical clippers from the midline of the back to the abdomen
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume with unit): 0.5 mL aliquot
- Concentration (if solution): Test substance used as received (unchanged)

Duration of treatment / exposure:
4 hours
Observation period:
Dermal irritation readings for erythema and edema were performed at 0.5, 24, 48, 72 and 168 hours after test substance removal. Grading and scoring of irritation were performed in accordance with the Draize scoring system.
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6 cm² (application site was located approximately 5-7 centimeters down from the backbone).
- % coverage: not specified
- Type of wrap if used: The test substance was covered with a 2.5 cm² - 2 layer gauze patch held in place with non-irritating Kendall Curity
Standard Porous Tape and the patch was then covered with a semi-occlusive plastic overwrap secured in place with Kendall Curity Standard Porous Tape for the duration of the exposure period.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, at the end of the 4 hour contact period residual material was removed from the site;
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
(indicate if minutes, hours or days) Dermal irritation readings for erythema and edema were performed at 0.5, 24, 48, 72 and 168 hours after
test substance removal.

SCORING SYSTEM:
- Method of calculation: Grading and scoring of irritation are performed in accordance with the Draize scoring system. The values for erythema and eschar formation are summed and divided by the number of animals scored for each observation period. Values for edema formation are summed and divided by the number of animals scored for each observation period. The average value for erythema/eschar formation and the average value for edema formation are summed to obtain the daily
irritation score.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0.43
Reversibility:
fully reversible within: 7 days
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0
Reversibility:
fully reversible within: 0.5 hours
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
-
Other effects:
- Other adverse local effects: None specified
- Other adverse systemic effects: None specified

Any other information on results incl. tables

Acute Skin Irritation

OBSERVATION TIME (HOURS)
 Rabbit Number  Sex

Initial Bwt.

(kg) 

 Final Bwt.

(kg)

ER

0.5 

 ED

0.5

 ER

24

ED

24 

ER

48 

ED

48 

ER

72 

ED

72 

ER

168 

ED

168 

 181  F  2.75 2.91  0
 182  F  2.70 2.76 
 183  F  3.01 3.10  1
         Average   1.0 0.33  0.67  0.33  0.33 
     Total         1.33     0.67     0.33       0.33     0
 

ER = Erythema

ED = Edema

Primary Skin Irritation Scores:

0.5 hours = 1.33

24 hours = 0.67

48 hours = 0.33

72 hours = 0.33

Primary Irritation Index (0.5, 24, 48 and 72 hour scores only) / 4 = 0.67

Applicant's summary and conclusion

Interpretation of results:
other:
Conclusions:
There were minimal irritation reactions in all of the test subjects which cleared by the 168 hour observation. The maximum skin irritation score was 1.33 at the 0.5 hour observation. The primary skin irritation index was calculated to be 0.67.

In accordance with the OPPTS Guidelines, Tall Oil TEA Salt, LAB 4483 meets the requirements for EPA Toxicity Category IV for dermal effects. According to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2015) (including all amendments), Tall oil TEA salt will not be classified for skin Irritation. According to the Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures (including all amendments), Tall oil TEA salt will not be classified for skin irritation.
Executive summary:

An acute dermal irritation study in male rabbits was performed using Tall Oil TEA Salt in accordance with U.S. EPA Health Effects Test Guidelines, OPPTS 870.2500 and OECD Guidelines for the Testing of Chemicals, Test No. 404. This study is reliable (Klimisch 1, reliable without restriction) with no deviations, and meets current US EPA and OECD guidence requirements.

Tall Oil TEA Salt, LAB 4473 was applied at a dose of 0.5 ml to an unabraded site on a clipped area of each of three albino rabbits. In all three dosed animals the site of application was graded for indication of skin reactions at 0.5, 24, 48, 72 and 168 hours after test substance removal. There were minimal skin irritation reactions in all test subjects which cleared by the 168 hour observation. The maximum skin irritation score was 1.33 at the 0.5 hour observation point. The primary skin irritation index was 0.67.

In accordance with the OPPTS Guidelines, Tall Oil TEA Salt LAB 4483 meets the requirements for EPA Toxicity Category IV for dermal effects. In accordence with the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2015) (including all amendments), and according to the Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures (including all amendments), Tall oil TEA salt does not warrant classiifcation for skin irritation.

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