Fatty acids, C16-18 (even numbered), reaction products with diethylene triamine, di-Me sulfate quaternized

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2010-03-23 to 2010-03-30

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, C16-18 (even numbered) and C18 unsatd., reaction products with diethylene triamine, di-Me sulfate quaternized

EC Number:

937-237-2

Molecular formula:

Molecular formula cannot be given as substance is a mixture.

IUPAC Name:

Fatty acids, C16-18 (even numbered) and C18 unsatd., reaction products with diethylene triamine, di-Me sulfate quaternized

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Age at study initiation: no data
- Weight at study initiation: 2818.2 9 and 2709.8 9 (female), 2912.6 9 (male). In deviation to the study plan the animals were slightly overweight (weight > 2500 g). However, this deviation is considered not affecting the outcome of the study.
- Housing: in steel cages with a plastic bottom, a non-barrier system with air conditioning was used.
- Diet: ad libitum, food of type "2023 Maintenance diet for rabbits " frorn Altramin, Lage, Germany as pelleted diet (Batch Nos.: 0926 and 1354; expiry dates: 2010-07-07 and 2010-12-02)
- Water: ad libitum, tap water from municipal source (SWK AQUA GmbH, Krefeld, Germany)
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C ± 3°C
- Humidity (%): 30 % -70 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the left eye remained untreated and served as a control.

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml of the test substance
- Concentration (if solution): unchanged

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

3 animals: 2-females, 1 male

Details on study design:

REMOVAL OF TEST SUBSTANCE
After recording the observations at 24 hours, the eyes of all rabbits were further examined with the aid of fluorescein. One drop of a 0.5 % (w/v) fluorescein solution in saline was poured into both eyes and washed off with saline solution 30 seconds later.

SCORING SYSTEM: the ocular reactions were assessed using the following numerical scoring system:
I.) Cornea opacity
No ulceration or opacity 0
Scattered or diffuse areas of opacity, details of iris clearly visible 1
Easily discernible translucent areas, details of iris slightly obscured 2
Nacreous areas, no details of iris visible, size of pupil barely discernible 3
Opaque cornea, iris not discernible thraugh the opacity 4

I.) Cornea area
No lesion 0
One quarter (or less) but not zero 1
Greater than one quarter, but less than one half 2
Greater than one half, but less than three quarters 3
Greater than three quarters, up to whole area 4

lI.) Iris
Normal 0
Markedly deepened rugae, congestion, swelling, moderate
circumcorneal hyperaemia or injection, iris still reactive to light 1
No reaction to light, haemorrhage, or grass destruction 2
III.) Conjunctivae redness
Vessels normal 0
Some blood vessels hyperaemic ( injected) above normal 1
More diffuse, crimson colour, individual vessels not easily discernible 2
Diffuse beefy red 3

III.) Conjunctivae chemosis
Normal 0
Some swelling above normal 1
Obvious swelling with partial eversion of lids 2
Swelling with lids about half closed 3
Swelling with lids more than half closed 4

III.) Conjunctivae discharge
No discharge 0
Any amount different from normal ( does not include
small amounts observed in inner canthus of normal animals) 1
Discharge with moistening of the lids and hairs just adjacent to the lids 2
Discharge with moistening of the lids and hairs and affecting
a considerable area around the eye 3

TOOL USED TO ASSESS SCORE: fluorescein (Fluorescein sodium C.I. 45350, Merck KGaA, Darmstadt, Germany)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: #1,#2,#3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

iris score

Basis:

animal: #1,#2,#3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal: #1,#2,#3

Time point:

24/48/72 h

Score:

1.33

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.67

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 5

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 6

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritant / corrosive response data:

All three animals showed moderate ocular reaction 1 h after application of the test substance (two scores for conjunctivae redness and chemosis). 24 h after application moderate ocular reactions were still observed in all three animals. Cornea opacity or iris irritation was not observed in any of the three animals. Slight irritation of the conjunctivae persists until 72 h after treatment in all animals but 7 days after application all three animals were without any sign of ocular irritation.

Other effects:

Symptoms of systemic toxicity caused by the test substance were not observed during the whole study. Body weight gain was positive and within normal range.

Any other information on results incl. tables

Examination of the treated eyes was carried out 1 hour and 24, 48, 72 hours and 7 days after application of the test substance.

		1 h	24 h	48 h	72 h	7 d	Mean (24h-72h)
I. Cornea opacity    Cornea area	A	0/0/0	0/0/0	0/0/0	0/0/0	0/0/0	0/0/0
	B	0/0/0	0/0/0	0/0/0	0/0/0	0/0/0	0/0/0
II. Iris	A	0/0/0	0/0/0	0/0/0	0/0/0	0/0/0	0/0/0
III. Conjunctivae redness      Conjunctivae chemosis      Conjunctivae discharge	A	2/2/2	2/2/2	1/1/1	1/1/1	0/0/0	1.33/1.33/1.33
	B	2/2/2	2/2/1	2/2/1	1/2/1	0/0/0	1.67/2/1
	C	1/1/1	1/1/1	0/0/0	0/0/0	0/0/0	0.33/0.33/0.33

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No 1272/2008)

Conclusions:

Moderate ocular reactions were observed within 24 hour following application of 0.1 mL of the test substance to the eyes. Effects on the cornea and the iris did not occur. The severity of the observed effects declined with time and the lesions were completely reversible within 7 days.

Executive summary:

In a primary eye irritation study according to OECD Guideline 405 (2002), 0.1 mL of partially unsaturated IQAC, DMS quaternised

(75 % in propylene-glycol) was instilled into the conjunctival sac of three New Zealand White rabbits. The eyes were not rinsed after substance application. Animals then were observed for 7 days. Irritation was scored by the method of Draize.

At 24 hours post application the eyes of all animals were further examined with fluorescein for cornea damage. All three animals showed moderate ocular reaction 1 h after application of the test substance (two scores for conjunctivae redness and chemosis). 24 h after application moderate ocular reactions were still observed in all three animals. Cornea opacity or iris irritation was not observed in any of the three animals. Slight irritation of the conjunctivae persisted until 72 h after treatment in all animals but 7 days after application all three animals were without any sign of ocular irritation.