1-Propanaminium, 2-hydroxy-N-(2-hydroxypropyl)-N,N-dimethyl-, esters with fatty acids, C16-18 (even numbered) and C18 unsatd., Me sulfates (salts)

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Remarks:

used to justify read-across

Adequacy of study:

supporting study

Study period:

1993-07-05 to 1993-07-12

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Ethanaminium, 2-hydroxy-N-(2-hydroxyethyl)-N,N-dimethyl-, esters with C16-18 and C18-unsatd. fatty acids, chlorides

Cas Number:

1079184-43-2

Molecular formula:

n.a. (UVCB)

IUPAC Name:

Ethanaminium, 2-hydroxy-N-(2-hydroxyethyl)-N,N-dimethyl-, esters with C16-18 and C18-unsatd. fatty acids, chlorides

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

- Name of test material (as cited in study report): BFA-base E 4708.01
- Diethyl ester dimethyl ammonium chloride
- Substance type: Waxy
- Physical state: Solid

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Dr. Karl Thomae GmbH
- Age at study initiation: 15 weeks
- Weight at study initiation: Male: 2.6 kg; Females: 2.6-2.7 kg
- Housing: Individually in stainless steel cages (size: 120 X 52 X 60 cm) equipped with feed hoppers and drinking water bottles
- Diet (e.g. ad libitum): Pelleted standard Kliba 341, Batch 77/93 rabbit maintenance diet, ad libitum
- Water (e.g. ad libitum): Community tap water from Fullinsdorf, ad libitum
- Acclimation period: 4 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 degrees C
- Humidity (%): 40-70%
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light/ 12 hours dark, music during the light period


IN-LIFE DATES: From: 1993-07-05 To: 1993- 07-12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: Counter lateral eye

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg, eye non rinsed
- Concentration (if solution): Not applicable


VEHICLE
- Amount(s) applied (volume or weight with unit): Not applicable
- Concentration (if solution): Not applicable
- Lot/batch no. (if required): Not applicable
- Purity: Not applicable

Duration of treatment / exposure:

100 mg of the test article (undiluted) was placed in the conjunctival sac of the left eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second to prevent loss of the test article.

Observation period (in vivo):

1, 24, 48 and 72 hours after instillation

Number of animals or in vitro replicates:

3 rabbits (1 male and 2 females)

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): rinsed
- Time after start of exposure: Not applicable


SCORING SYSTEM: according to Draize


TOOL USED TO ASSESS SCORE: hand-slit lamp 30 SL/M and a Varta Cliptrix diagnostic-lamp

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Remarks:

100 mg undiluted test material non-rinsed

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

Remarks:

100 mg undiluted test material non-rinsed

Basis:

animal: #1, #2, #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

conjunctivae score

Remarks:

100 mg undiluted test material non-rinsed

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

conjunctivae score

Remarks:

100 mg undiluted test material non-rinsed

Basis:

animal: #2, #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Results 5

Irritation parameter:

chemosis score

Remarks:

100 mg undiluted test material non-rinsed

Basis:

animal: #1, #2, #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

The left eyes of a group of 3 rabbits were instilled with 100mg of undiluted test substance. The eyes were not rinsed. Mild conjuctival redness was observed in the eyes of 3/3 and 2/3 animals at the 1 hour reading and 24 hours, respecitvly that cleared by 48 hours. CHemosis was observed in the eyes of 2/3 animals at 1 hour reading which also cleared by 48 hours.

Other effects:

Normal weight gains and no clinical signs were observed during study.

Any other information on results incl. tables

Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility	Cornea	Iris	Conjunctivae	Chemosis
	Max. score: 4	Max. score: 2	Max. score: 3	Max. score: 4
60 min	0/0/0	0/0/0	1/1/1	1/1/0
24 h	0/0/0	0/0/0	0/1/1	0/0/0
48 h	0/0/0	0/0/0	0/0/0	0/0/0
72 h	0/0/0	0/0/0	0/0/0	0/0/0
Average 24h, 48h, 72h	0	0	0/0.33/0.33	0
Area effected
Maximum average score (including area affected, max 110)
Reversibility*)	C	C	C	C
Average time (unit) for reversion

 *) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

A very slight irritation was observed untill the 24 hour reading with max. scores of 1 for conjunctivae and chemosis. All symptomes were reversible at the 48 hour reading.

Executive summary:

In a primary eye irritation study according to OECD guideline 405, 12 May 1981, 100 mg of a MDEA-Esterquat C16-18 and C18 unsatd. with the same structure but a different distribution of the fatty acid moiety which contains a higher amount of unsaturated C18´ (Iodine Value 50) was instilled into the conjunctival sac of the left eye of young adult New Zealand white rabbits, 1male and 2 female. Animals then were observed for 72 hours.  Irritation was scored by the method of Draize. Mild conjunctival redness (score 1) was observed in 3/3 rabbits after 1 hour and was present in 2/3 animals at the 24 hour reading. Reversibility was shown within 48 hours. Chemosis (score 1) was observed in 2/3 rabbits and was reversible within 24 hours.

In this study the mean grades of ocular reactions at 24, 48 and 72 h after instillation were lower than the values classified as irritant by the Directive 67/548/EEC as well as GHS Regulation EC No 1272/2008.

When administered to the eye, the test article MDEA-Esterquat C16-18 and C18 unsatd. (Iodine value 50) is classified as "non-irritant".