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

Eye irritation

Administrative data

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

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 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

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 / tissue source

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

Test system

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

Results and discussion

In vivo

Results

Results 1

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

Results 2

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

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0.11

Max. score:

4

Reversibility:

fully reversible

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Applicant's summary and conclusion

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.