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

Endpoint summary

Description of key information

Organolignite was neither a dermal or ocular irritant based on the lack of irritation observed in OECD 404 and 405 studies.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

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

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)

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: No erythema was observed

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: No edema was observed

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2013-07-09 to 2013-07-23

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

In the opinion of the Study Director, there is no impact on the quality or integrity of the study in connection to this deviation.

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Covance Research Products, Inc., Greenfield, Indiana
- Age at study initiation: Approximately 5 months
- Weight at study initiation: 2.83 to 3.52 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

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1 g of solid

Duration of treatment / exposure:

24 hr

Observation period (in vivo):

1, 24, 48, 72 hr following dose administration

Number of animals or in vitro replicates:

3 males

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: immediately following the 24 hr scoring

SCORING SYSTEM: Draize scale

TOOL USED TO ASSESS SCORE: fluorescein

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: No ulceration or opacity was observed

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: No ocular irritation of the iris was observed

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0.11

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Interpretation of results:

GHS criteria not met

Conclusions:

No ocular irritation was observed during the 24 to 72 hour observation periods of the study. Reddening (Grade 1) of the conjunctivae and conjunctivae sac, as well as ocular discharge, were noted during the 1 hour observation period, but were resolved by 24 hours post dose. In this study, organolignite is not an ocular irritant based on the lack of irritation observed during the 24 to 72 hour observation periods.

Executive summary:

In a primary eye irritation study, 0.1 g of organolignite (solid) was instilled into the conjunctival sac of the right eye of New Zealand White Hra: (NZW) SPF albino rabbits (3 males) for 24 hours. Eyes were immediately washed following the 24 hour scoring and sodium fluorescein examination. Animals then were then observed for 3 days, and ocular irritation evaluations were conducted at approximately 1, 24, 48, and 72 hours following dose administration. Irritation was scored by the method of Draize.

 

No ocular irritation was observed during the 24 to 72 hour observation periods of the study. Reddening (Grade 1) of the conjunctivae and conjunctivae sac, as well as ocular discharge, were noted during the 1 hour observation period, but were resolved by 24 hours post dose. Based on the study results, organolignite is not an ocular irritant since no irritation was observed during the 24 to 72 hour observation period.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Organolignite was neither a dermal or ocular irritant based on the lack of irritation observed in OECD 404 and 405 studies. Study details are provided below.

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.

In a primary eye irritation study, 0.1 g of organolignite (solid) was instilled into the conjunctival sac of the right eye of New Zealand White Hra: (NZW) SPF albino rabbits (3 males) for 24 hours. Eyes were immediately washed following the 24 hour scoring and sodium fluorescein examination. Animals then were then observed for 3 days, and ocular irritation evaluations were conducted at approximately 1, 24, 48, and 72 hours following dose administration. Irritation was scored by the method of Draize.

 

No ocular irritation was observed during the 24 to 72 hour observation periods of the study. Reddening (Grade 1) of the conjunctivae and conjunctivae sac, as well as ocular discharge, were noted during the 1 hour observation period, but were resolved by 24 hours post dose. Based on the study results, organolignite is not an ocular irritant since no irritation was observed during the 24 to 72 hour observation period.

Justification for classification or non-classification

Organolignite does not meet the criteria for classification and labelling as a skin irritant under CLP EU Regulation 1272/2008 based on evaluation of the overall mean erythema and oedema scores from a key skin irritation study.

Organolignite does not meet the criteria for classification and labelling as an eye irritant as defined by CLP EU Regulation 1272/2008 based on evaluation of overall mean eye irritation scores from a key eye irritation study.