Quaternary ammonium compounds, bis(hydrogenated tallow alkyl)dimethyl, chlorides, reaction products with polyethylenepolyamines and tall-oil fatty acids, humates hydrochlorides

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2013-06-27 to 2013-07-02

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Test material form:

solid: particulate/powder

Details on test material:

- Substance type: UVCB
- Physical state: powder

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Covance Research Products, Inc., Greenfield, Indiana
- Age at study initiation: Approximately 8 ½ months
- Weight at study initiation: 3.83 to 3.92 kg
- Housing: Individually housed in suspended, stainless steel, slatted floor cages
- Diet (e.g., ad libitum): Lab Diet® Certified Rabbit Diet #5322 limited upon arrival and increased in 25 g increments during the acclimation period until feeding was 125 g per day
- Water (e.g., ad libitum): Tap water available ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): ~ 16 to 22°C (61 to 72°F)
- Humidity (%): 30 to 70%
- Photoperiod (hrs dark / hrs light): 12 hr dark/12 hr light

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): Test material mixed with water to form a paste; the final ratio of test article to deionized water used for each application was 1:2.

Duration of treatment / exposure:

4 hr

Observation period:

1, 24, 48, and 72 hours following the 4 hour dose period (patch removal)

Number of animals:

3 males

Details on study design:

TEST SITE
- Area of exposure: Test article was placed on gauze patches (approximately 6 cm2) and then applied to the skin on the right side of the dorsal trunk
- Type of wrap if used: Gauze

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes with tepid tap water and a WypAll®
- Time after start of exposure: After the 4 hr exposure

SCORING SYSTEM: Draize scale

Erythema and Eschar Formation

0 No erythema
1 Very slight erythema (barely perceptible)
2 Well-defined erythema
3 Moderate to severe erythema
4 Severe erythema (beet redness) to slight eschar formation (injuries in depth)

Edema Formation

0 No edema
1 Very slight edema (barely perceptible)
2 Slight edema (edges of area well-defined by definite raising)
3 Moderate edema (raised approximately 1 mm)
4 Severe edema (raised more than 1 mm and extending beyond area of exposure)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: No erythema was observed

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: No edema was observed

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

No dermal irritation was observed at any point in the study, with the mean erythema and edema score both being 0 over 24 to 72 hr. In this study, organolignite is not a dermal irritant based on the lack of irritation observed throughout the study period.

Executive summary:

In a primary dermal irritation study, three male New Zealand White Hra:(NZW)SPF albino rabbits were dermally exposed to 0.5 g of organolignite for 4 hours under semi-occlusive conditions. Organolignite was moistened with deionized water to form a paste and final ratio of test article to deionized water used for each application was 1:2. Animals then were observed for 3 days. Irritation was scored by the Draize method.

 

No dermal irritation was observed at any point in the study, with the mean erythema and oedema score both being 0 over 24 to 72 hr. Based on the study results, organolignite is not a dermal irritant since no irritation was observed throughout the study period.