[No public or meaningful name is available]

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

REPORTING FORMAT FOR THE ANALOGUE APPROACH

1. HYPOTHESIS FOR THE ANALOGUE APPROACH
This read-across is based on the hypothesis that source and target substances have similar toxicological and ecotoxicological properties because they share structural similarities with common functional groups: quaternary amines, esters, and fatty acid chains varying in their length and degree of (un)saturation. Moreover, the fatty acid chains are chemically simple structures which have no structural alerts for toxicity, and which are closely related to substances of known low toxicity (i.e. stearic acid, oleic acid, linoleic acid, linolenic acid). Furthermore, the substances can be expected to have comparable breakdown products (MDEA or MDIPA and long chain fatty acids).

This read-across hypothesis corresponds to scenario 2 - different compounds have qualitatively and quantitatively the same type of effects - of the read-across assessment framework i.e. properties of the target substance MDEA-Esterquat C18 unsatd. are predicted to be similar to those of the source substances MDIPA Esterquat C18 unsatd., MDEA-Esterquat C16-18 and C18 unsatd. and MDIPA-Esterquat C16-18 and C18 unsatd.

Therefore, read-across from the available physicochemistry, toxicity and ecotoxicity studies with the source substances MDIPA Esterquat C18 unsatd., MDEA-Esterquat C16-18 and C18 unsatd. and MDIPA-Esterquat C16-18 and C18 unsatd. are considered as an appropriate adaptation to the standard information requirements of the REACH Regulation for the target substance MDEA-Esterquat C18 unsatd., in accordance with the provisions of Annex XI, 1.5 of the REACH Regulation.


2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
please refer to read-across justification attached to Iuclid section 13

3. ANALOGUE APPROACH JUSTIFICATION
please refer to read-across justification attached to Iuclid section 13

4. DATA MATRIX
please refer to read-across justification attached to Iuclid section 13

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

read-across: supporting information

Cross-reference 2

Reason / purpose for cross-reference:

read-across source

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1986-03-17 to 1986-03-24

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

-10 mg solid dose instead of 100 mg as specfied by OECD 405 guidelines

GLP compliance:

yes

Specific details on test material used for the study:

- Diethylester dimethyl ammonium chloride
- Substance type: Waxy

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Buckmasters, Henham,Hartfordshire, England
- Age at study initiation: 10-14 weeks
- Weight at study initiation: 2.3-3.2 kg
- Housing: Metal cages with perforated floors
- Diet (e.g. ad libitum): SDS standerd Rabbit Diet,ad libitum
- Water (e.g. ad libitum): Tap water,ad libitum
- Acclimation period:Not given


ENVIRONMENTAL CONDITIONS
- Temperature (°C):19 °C
- Humidity (%): 30-70%
- Air changes (per hr): 19 air charges /hour
- Photoperiod (hrs dark / hrs light): 12 hours of artificial light in each 24 hrs period.


IN-LIFE DATES: From:1986-03-17 To: 1986-03-24

Vehicle:

unchanged (no vehicle)

Controls:

other: Counter lateral eye.

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 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:

4 seconds in Group 2 and 7 days in Group 1

Observation period (in vivo):

24, 48, 72 hrs, 4, and 7 days after instillation for Group I and Group 2.

Number of animals or in vitro replicates:

Group 1: 6 Rabbits (10 mg undiluted test material, non-rinsed),
Group 2: 3 Rabbits (10mg undiluted test material, rinsed 4 seconds after instillation)

Details on study design:

The test substance is placed directly on the cornea of rabbit eye

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Group 1 unwashed, Group 2 washing with 20 ml of lukewarm tap water.
- Time after start of exposure: 4 seconds in Group 2


SCORING SYSTEM: Draize Scoring system.


TOOL USED TO ASSESS SCORE: hand-slit lamp

Irritation parameter:

cornea opacity score

Remarks:

10 mg undiluted test material non-rinsed

Basis:

animal: #1 - #6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Remarks:

10 mg undiluted test material non-rinsed

Basis:

animal: #1 - #6

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Remarks:

10 mg undiluted test material non-rinsed

Basis:

animal: #1 - #6

Time point:

24/48/72 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

chemosis score

Remarks:

10 mg undiluted test material non-rinsed

Basis:

animal: #1 - #6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

cornea opacity score

Remarks:

10 mg undiluted test material rinsed group

Basis:

animal: #1, #2, #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Remarks:

10 mg undiluted test material rinsed group

Basis:

animal: #1, #2, #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Remarks:

10 mg undiluted test material rinsed group

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Remarks:

10 mg undiluted test material rinsed group

Basis:

animal: #1, #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

chemosis score

Remarks:

10 mg undiluted test material rinsed group

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 eyes of two respective group of 6 and 3 rabbits were instilled with 10 mg of undiluted test substance. The eyes of the first group of 6 rabbits were not rinsed and the second group of 3 rabbits were rinsed. No ocular irritation was observed in the non-rinsed group of 6 rabbits 24 hours after instillation. Mild conjunctival redness (overall ocular irritation score was 0.67 at 24 hours) was observed in the eyes of 2/3 rabbits in the 10 mg rinsed group that cleared by 48 hours.

Other effects:

None observed.

Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test group 1 (not rinsed)

Score at time point / Reversibility	Cornea	Iris	Conjunctivae	Chemosis
	Max. score: 4	Max. score: 2	Max. score: 3	Max. score: 4
60 min	-	-	-	-
24 h	0/0/0/0/0/0	0/0/0/0/0/0	0/0/0/0/0/0	0/0/0/0/0/0
48 h	0/0/0/0/0/0	0/0/0/0/0/0	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	0/0/0/0/0/0	0/0/0/0/0/0
Average 24h, 48h, 72h	0	0	0	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

Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test group 2 (rinsed)

Score at time point / Reversibility	Cornea	Iris	Conjunctivae	Chemosis
	Max. score: 4	Max. score: 2	Max. score: 3	Max. score: 4
60 min	-	-	-	-
24 h	0/0/0	0/0/0	1/0/1	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	0.33/0/0.33	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

Interpretation of results:

study cannot be used for classification

Conclusions:

No occular irritation was observed in the non-rinsed group.
A very slight irritation was observed untill the 24 hour reading with max. scores of 1 for conjunctivae. All symptomes were reversible at the 48 hour reading.

Executive summary:

In a primary eye irritation study comparable to OECD guideline 405,10 mg of MDEA-Esterquat C16-18 and C18 unsatd. was directly applied onto the cornea of one eye of six young adult New Zealand rabbits each and observed for 7 days. A subgroup of 3 additional rabbits was treated in the same matter, but eyes were rinsed 4 sec. after instillation of test substance.

Animals then were observed for 7 days.  Irritation was scored by the method of Draize.

In the main group no eye irritation was observed, all readings were zero. Mild conjunctival redness (score 1) was observed in 2/3 rabbits of subgroup (rinsed group)after 24 hours and was reversible within 48 hours.

 

No information on content of active ingredient of the test substance in this study report. However, according to producer information test substance has 80 % a.i.

 

In this study, MDEA-Esterquat C16-18 and C18 unsatd. is not an eye irritant.

 

Due to the low volume applied, the results of this study are not adequate for classification and labelling purposes.

Cross-reference 3

Reason / purpose for cross-reference:

read-across source

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1993-07-05 to 1993-07-12

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

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

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

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

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

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

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

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

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.

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

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".

 

Cross-reference 4

Reason / purpose for cross-reference:

read-across source

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

2011-12-06 to 2012-01-25

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study. GLP.

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

31 May 2008

Deviations:

no

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

24 April 2002

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Age at study initiation: 12 – 20 weeks
- Weight at study initiation: 2.64 - 2.94 kg
- Housing: individually in suspended cages
- Diet (e.g. ad libitum): 2930C Teklad Global Rabbit diet supplied by Harlan Laboratories UK Ltd., Oxon, UK, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23°C
- Humidity (%): 30 to 70%
- Air changes (per hr): at least 15/h
- Photoperiod (hrs dark / hrs light): 12/12

Vehicle:

other: olive oil

Controls:

other: the contralateral eye was treated with 0.1 mL olive oil as vehicle control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): 20% in olive oil

Duration of treatment / exposure:

the eyes were not rinsed after treatment

Observation period (in vivo):

21 d

Number of animals or in vitro replicates:

2

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the eyes were not rinsed

SCORING SYSTEM: Draize scale, OECD guideline 405

TOOL USED TO ASSESS SCORE: light source from a standard ophthalmoscope

Irritation parameter:

cornea opacity score

Basis:

animal: #1, #2

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 14 d

Remarks on result:

other: vascularisation was still present in animal #2 at day 14 and 21

Irritation parameter:

iris score

Basis:

animal: #1, #2

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 7 to 14 d

Irritation parameter:

conjunctivae score

Basis:

animal: #1, #2

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

not fully reversible within: 14 d

Remarks on result:

other: grade 1 redness still present in animal #2 on day 14, reversible within 21 d

Irritation parameter:

chemosis score

Basis:

animal: #1, #2

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 14 d

Irritant / corrosive response data:

Test item:
Scattered or diffuse corneal opacity (grade 1) was noted in one treated eye one hour after treatment and in both treated eyes at the 24, 48, 72 h and 7 d observations. Vascularisation, with a localised ingrowth of vessels at the lower edge of the cornea, was noted in one treated eye at the 14 and 21 d observations.
Iridial inflammation (grade 1) was noted in one treated eye one hour after treatment, in both treated eyes at the 24, 48, 72 h observations and in one treated eye at the 7 d observation.
Moderate conjunctival irritation (grade redness and grade 2 chemosis) was noted in both treated eyes one hour after treatment and at the 24, 48 and 72 h observations. Moderate conjunctival irritation was noted in one treated eye and minimal conjunctival irritation was noted in the other treated eye at the 7 d observation. Minimal conjunctival irritation was noted in one treated eye at the 14 d observation. Petechial haemorrhage over the nictitating membrane was noted in one treated eye at the 72 h observation. Alopecia around the treated eye was noted in one animal at the 7 d observation.
One treated eye appeared normal at the 14 d observation. The corneal vascularisation noted in one treated eye was considered to be irreversible.

Vehicle control:
No corneal or iridial effects were noted during the study. Minimal conjunctival irritation was noted in both treated eyes one hour after treatment. Both treated eyes appeared normal at the 24 h observation.

Other effects:

Both animals showed expected gain in bodyweight during the study.

Irritant/corrosive response data for each animal at each observation time: test substance

Timepoint	Cornea		Iris	Conjunctivae		Discharge
	score	area		redness	swelling
1 h	0/1	0/2	0/1	2/2	2/2	2/2
24 h	1/1	2/2	1/1	2/2	2/2	3/2
48 h	1/1	2/2	1/1	2/2	2/2	2/2
72 h	1/1	1/3	1/1	2/2Pt	2/2	1/2
7 days	1/1	1/2	0/1	1Al/2	1/1	1/1
14 days	0/0V	0/0	0/0	0/1	0/0	0/1
21 days	-/0V	-/0	-/0	-/0	-/0	-/0
Average 24h, 48h, 72h	1/1	Not calculated	1/1	2/2	2/2	Not calculated

  - = not assessed

Al = Alopecia around the treated eye

Pt = Petechial haemorrhage over the nictitating membrane

V =Vascularisation, with a localised ingrowth of vessels at the lower edge of the cornea

Irritant/corrosive response data for each animal at each observation time: vehicle control

Timepoint	Cornea		Iris	Conjunctivae		Discharge
	score	area		redness	swelling
1 h	0/0	0/0	0/0	1/1	1/0	0/0
24 h	0/0	0/0	0/0	0/0	0/0	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
7 days	0/0	0/0	0/0	0/0	0/0	0/0
14 days	0/0	0/0	0/0	0/0	0/0	0/0
Average 24h, 48h, 72h	0/0	Not calculated	0/0	0/0	0/0	Not calculated

 

Interpretation of results:

Category 1 (irreversible effects on the eye)

Remarks:

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

Conclusions:

In this in vivo eye irritation test, MDIPA Esterquat C18 unsatd. (20% dilution in olive oil) produced irreversible effects to the eye and thus has to be classified as Category 1 (irreversible effects on the eye).

Executive summary:

In a primary eye irritation study according to OECD guideline 405 (24 April 2002) and EU method B.5 (31 May 2008) 0.1 mL of MDIPA Esterquat C18 unsatd.

(20% in olive oil) was instilled into the conjunctival sac of the right eyeof 2 male New Zealand White rabbits. The contralateral eye was treated with 0.1 mL olive oil as vehicle control. The eyes were not rinsed after application. Animals were then observed for 21 days.  Irritation was scored by the method of Draize.

No corneal or iridial effects were noted in the vehicle control, only minimal conjunctival irritation was noted in both treated eyes one hour after treatment. Both eyes appeared normal at the 24 h observation. The test substance produced scattered or diffuse corneal opacity (grade 1) in one eye one hour after treatment and in both treated eyes for up to 7 days. Vascularisation with a localised ingrowth of vessels at the lower edge of the cornea, was noted in one treated eye at the 14 and 21 d observations. Iridial inflammation (grade 1) was observed, which was reversible within 7 or 14 days.

Moderate conjunctival irritation (grade 2 redness and grade 2 chemosis) was noted in both treated eyes. This was reversible in one animal within 14 d. But minimal conjunctival irritation (grade 1 redness) was still present in one treated eye at the 14 d observation.

One treated eye appeared normal at the 14 d observation. The corneal vascularisation observed in one treated eye was considered to be irreversible.

Thus, a 20% dilution of MDIPA Esterquat C18 unsatd. in olive oil

produced irreversible effects to the eye and thus has to be classified as Category 1 (irreversible effects on the eye).

Materials and methods

Test material

Test material information

Constituent 1

Reference substance name:

Ethanaminium, 2-hydroxy-N-(2-hydroxyethyl)-N,N-dimethyl-, diesters with C18-unsatd. fatty acids, Me sulfates

Molecular formula:

n.a.

IUPAC Name:

Ethanaminium, 2-hydroxy-N-(2-hydroxyethyl)-N,N-dimethyl-, diesters with C18-unsatd. fatty acids, Me sulfates

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: #1, #2

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 14 d

Results 2

Irritation parameter:

iris score

Basis:

animal: #1, #2

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 7 - 14 d

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal: #1, #2

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

not fully reversible within: 14 d

Results 4

Irritation parameter:

chemosis score

Basis:

animal: #1, #2

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 14 d

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Conclusions:

Based on the available data, it can be concluded that the available data on eye irritation from the source substances MDEA-Esterquat C16-18 and C18 unsatd., MDIPA-Esterquat C16-18 and C18 unsatd., and MDIPA-Esterquat C18 unsatd. can be applied to the target substance MDEA-Esterquat C18 unsatd. The results obtained with the source substance MDIPA-Esterquat C18 unsatd. are considered the most relevant for the target substance. Therefore, MDEA-Esterquat C18 unsatd. is classified as Eye Damage 1.