Reaction products of C18 (unsaturated) fatty acids and dimethyl sulfate and triethanolamine

Endpoint summary

Description of key information

skin irritation:

- irritating (Cat 2); OECD TG 404, in vivo, rabbit, RL1; GLP (4 h semiocclusive)

- SCL: 28%: not irritating

 

eye irritation:

- irritating (Cat 2); OECD TG 405, in vivo, rabbit, RL1; GLP

- SCL: 28%: not irritating

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Reference 1

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL

Duration of treatment / exposure:

duration of treatment was 4 hours

Observation period:

reaction was evaluated approx. 30-60 minutes and 24, 48 and 72 hours after the end of exposure period. Additional observations after 6, 9, 13 and 14 days

Number of animals:

3 animals

Details on study design:

TEST SITE
- Area of exposure: 6 cm2
- Type of wrap if used: the substance was placed on 2.5 x 2.5 cm squares of hydrophyllic gauze and applied to the corresponding test area. The resulting patches were held close to the body using strips of adhesive tape. Finally, a strip of gauze was wrapped around the trunk of the animal and fixed to the body using additional adhesive tape.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing

SCORING SYSTEM: according to Draize

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2.67

Max. score:

4

Reversibility:

fully reversible within: 13 days

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 9 days

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 14 days

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 9 days

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 6 days

Irritant / corrosive response data:

In the readings carried out 24, 48 and 72 hours after administration all of the animals showed erythematic lesions ranging from well defined erythema (grade 2) to marked erythema (grade 3), accompanied by edematic lesions ranging from very slight edema (grade 1) to slight edema (grade 2) and
dryness of the skin.
In the readings carried out on administration days 6, 9 and 13 observed reactions were disappearing in the majority of the animals. Severe dryness of the skin and eschars in the treated areas was observed in nearly all of the animals. At the end of the treatment (day 14), only one animal presented
light eschars in the treated area.

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

Classification is based on erythema/eschar and oedema calculated as mean scores following grading at 24, 48 and 72 hours after removal of the test material, in consideration of reversibility.
Classification for skin irritation is justified for the oleic acid-based TEA-Esterquat according to CLP, EU GHS (Regulation (EC) No 1272/2008) and
Directive 67/548/EEC.

Executive summary:

In a primary dermal irritation study according to OECD Guideline 404 1992, three New Zealand White rabbits were semi-occlusive dermally exposed to 0.5 mL of the oleic acid-based TEA-Esterquat for 4 hours to approximately 6 cm² of body surface area. Animals then were observed for 14 days. Irritation was scored by the method of Draize as stipulated by OECD Guideline 404.

 

In the readings carried out 24, 48 and 72 hours after administration all of the animals showed erythematic lesions ranging from well defined erythema (grade 2 to marked erythema (grade 3), accompanied by edematic lesions ranging from very slight edema (grade 1) to slight edema (grade 2) and dryness of the skin.

Effects were reversible within the 14 day observation period. In one animal, light eschars were recorded at study termination at day 14. 

Reference 2

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL

Duration of treatment / exposure:

the duration of treatment was 4 hours

Observation period:

reaction was evaluated approx. 30-60 minutes and 24, 48 and 72 hours after the end of exposure period; additionally after 7 days

Number of animals:

3 animals

Details on study design:

TEST SITE
- Area of exposure: 6 cm2
- Type of wrap if used: the substance was placed on 2.5 x 2.5 cm squares of surgical gauze and applied to the corresponding test area. The resulting patches were held close to the body using strips of adhesive tape. Finally, a strip of gauze was wrapped around the trunk of the animal and fixed to the body using additional adhesive tape.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing

SCORING SYSTEM: according to Draize

Irritation parameter:

erythema score

Basis:

animal: #1, #2, #3

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritant / corrosive response data:

In the examinations carried out in the first 60 minutes and 24 hours, all the animals showed well defined erythema (grade 2). In addition, slight edema (grade 2) appeared in two of them and moderate edema (grade 3) in the remaining animal. 48 and 72 hours after treatment, all the animals continued to show well defined erythema (grade 2), while the edema was subsiding.
In an additional reading carried out on day 7 after treatment, the skin alteration observed in the previous readings had totally disappeared, only dryness of the skin was observed in all the animals.

Interpretation of results:

GHS criteria not met

Conclusions:

Classification is based on erythema/eschar and oedema calculated as mean scores following grading at 24, 48 and 72 hours after removal of the test material, in consideration of reversibility.
No classification for skin irritation is justified for the oleic acid-based TEA-Esterquat according to CLP, EU GHS (Regulation (EC) No 1272/2008).

Executive summary:

In a primary dermal irritation study according to OECD Guideline 404 1992, three White New Zealand rabbits were semi-occlusive dermally exposed to 0.5 mL of the oleic acid-based TEA-Esterquat (80 % a.i. and 20 % DPG) for 4 hours to approximately 6 cm² of body surface area. Animals then were observed for 7 days. Irritation was scored by the method of Draize as stipulated by OECD Guideline 404.

In the examinations carried out in the first 60 minutes and 24 hours, all the animals showed well defined erythema (grade 2). In addition, slight edema (grade 2) appeared in two of them and moderate edema (grade 3) in the remaining animal. 48 and 72 hours after treatment, all the animals continued to show well defined erythema (grade 2), while the edema was subsiding. Effects were fully reversible at day 7 after treatment.

Reference 3

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

not specified

Remarks:

most probably water

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): 28 % a.i.

Duration of treatment / exposure:

4 hours

Observation period:

30-60 minutes and 24, 48 and 72 hours after the end of the exposure period. Additional observations were carried out after 7 days
to checkthe reversibility of the observed reactions.

Number of animals:

3 animals

Details on study design:

TEST SITE
- Area of exposure: The substance was placed on 2.5 x 2.5 cm squares of surgical gauze and applied to the corresponding test area
- % coverage: The resulting patches were held close to the body using strips of adhesive tape. Finally, a strip of gauze was wrapped around the trunk of the animal in order to hold the patches in place. The gauze was fixed to the body using additional adhesive tape.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): the remainder of the product being removed with water.
- Time after start of exposure: 4 hours

SCORING SYSTEM: according to the OECD test guideline 404, 1992-07-17

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritation parameter:

edema score

Basis:

animal: #1, #2, #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

Approximately 60 minutes after the patches were removed, well defined erythema (grade 2) was observed in all the animals.
In the reading carried out at 24 hours after removing the patches two animals showed very slight erythema (grade I) and the remaining animal well
defined erythema (grade 2).
Symptoms decreased with time and 7 days post-treatment, the alterations had totally disappeared, and only dryness of the skin was observed in two animals.

Other effects:

The behaviour and physical conditionoftile rabbits were normal throughout the Study.

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

 

Time point	Erythema Max score 4	Edema Max score 4
60 minutes	2/2/2	0/0/0
24 hours	1/2/1	0/0/0
48 hours	1/1/1	0/0/0
72 hours	0/1/1	0/0/0
7 days	-/0/0	-/0/0
Average 24, 48, 72 hours	0.67/1.33/1	0/0/0
Reversibility*)	c/c/c
Time (unit) for reversion	within 7 days

 

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

 

 

Interpretation of results:

GHS criteria not met

Remarks:

28 % dilution of test substance

Conclusions:

Classification is based on erythema/eschar and oedema calculated as mean scores following grading at 24, 48 and 72 hours after removal of the test material, in consideration of reversibility.
No classification for skin irritation is justified for the oleic acid-based TEA-Esterquat, according to CLP, EU GHS (Regulation (EC) No 1272/2008).

Executive summary:

In a primary dermal irritation study according to OECD Guideline 404 1992, three New Zealand White rabbits were semi-occlusive dermally exposed to 0.5 mL of the oleic acid-based TEA-Esterquat (28 % a.i.) for 4 hours to approximately 6 cm² of body surface area. Animals then were observed for 7 days. Irritation was scored by the method stipulated by OECD Guideline 404.

Approximately 60 minutes after patches removal, well defined erythema (grade 2) was observed in all the animals. At the 24 hours after reading two animals showed very slight erythema (grade I) and the third animal well defined erythema (grade 2). Symptoms decreased with time and 7 days post-treatment, the alterations had totally disappeared, and only dryness of the skin was observed in two animals.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Eye irritation

Link to relevant study records

Reference

Reference 1

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1996-05-13 to 1996-06-04

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Vehicle:

not specified

Remarks:

most probably water

Controls:

other: untreated eye served as control

Amount / concentration applied:

0.1 mL of 28 % a.i. dilution of test substance

Duration of treatment / exposure:

no washing

Observation period (in vivo):

1, 24, 48 and 72 hours. Additional observations were carried out after 7 days to check the reversiblitlity of the observed reactions.

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not done

SCORING SYSTEM: as outlined in the OECD guideline 405, 1987

TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein

In the readings at 24 and 48 hours after treatment cornea was observed, by applying a 2 % aqueous sodium fluorescein solution to test the area and
then washing the area with a 0.9 % physiological saline solution. Once surplus fluorescein had been removed, the corneal alterations were observed
with the 'lid of a transilluminator with a cobalt blue filter.

Irritation parameter:

cornea opacity score

Basis:

animal: #1, #2, #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

iris score

Basis:

animal: #1, #2, #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Irritation parameter:

conjunctivae score

Basis:

animal: #1, #2, #3

Time point:

24/48/72 h

Score:

1.33

Max. score:

3

Reversibility:

fully reversible within: 7 days

Irritation parameter:

chemosis score

Basis:

animal: #1, #2, #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Irritant / corrosive response data:

At the 60 minute and 24 hour reading moderate conjunctival redness (score 2) and mild to moderate chemosis (score 1 and 2) was observed.
Symptoms decrease with time, scores were 0 at the 48 hour reading for chemosis and after 7 days for conjuncitva. Cornea damage and iritis was not observed at any time during the study.

Other effects:

The behaviour and physical condition of the rabbits were normal throughout the 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	2/2/2	2/2/1
24 h	0/0/0	0/0/0	2/2/2	1/1/1
48 h	0/0/0	0/0/0	1/1/1	0/0/0
72 h	0/0/0	0/0/0	1/1/1	0/0/0
7days	0/0/0	0/0/0	0/0/0	0/0/0
Average 24h, 48h, 72h	0/0/0	0/0/0	1.33/1.33/1.33	0.33/0.33/0.33
Reversibility*)	c/c/c	c/c/c	c/c/c	c/c/c
Average time (unit) for reversion			7 days

 

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

Interpretation of results:

GHS criteria not met

Remarks:

28 % dilution of test substance

Conclusions:

Classification is based on effects on the cornea, iris and conjunctiva calculated as mean scores following grading at 24, 48 and 72 hours after
instillation of the test material, in consideration of reversibility.
No classification for serious eye damage/eye irritation is justified for the oleic acid-based TEA-Esterquat (28 % a.i. dilution) according to CLP, EU GHS
(Regulation (EC) No 1272/2008).

Executive summary:

In a primary eye irritation study according to OECD Guideline 405, 1987 0.1 mL of the oleic acid-base TEA-Estequat was instilled into the conjunctival sac of three New Zealand White rabbits. Animals then were observed for 7 days. Irritation was scored by the method stipulated by the OECD Guideline 405.

At the 60 minute and 24 hour reading moderate conjunctival redness (score 2) and mild to moderate chemosis (score 1 and 2) was observed in all animals. Symptoms decrease with time. Scores were zero at the 48 hour reading for chemosis and after 7 days for conjuncitva. Cornea damage and iritis was not observed at any time during the study.

Reference 2

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2010-04-07 to 2010-05-10

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

2002

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

2008

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

New Zealand White

Vehicle:

unchanged (no vehicle)

Controls:

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

Amount / concentration applied:

0.1 ml of the test substance was applied by means of a syringe to the eye of the animals.

Duration of treatment / exposure:

eyes were not rinsed

Observation period (in vivo):

1 hour and 24, 48, 72 hours and 7, 14, 21 and 28 days after application of the test substance.

Number of animals or in vitro replicates:

3 animals, 1 male and 2 females

Details on study design:

SCORING SYSTEM: as outlined in the OECD guideline 405, 2002

TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein
Examinations of ocular reactions were facilitated without any device. After recording the observations at 24 hours, the eyes of all rabbits were further examined with the aid of fluorescein to look for damage of the cornea.
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. Afterwards
scoring was executed by use of an UV-light lamp. This procedure was repeated at all observation time points until cornea damage was no longer
observed.

Irritation parameter:

cornea opacity score

Basis:

animal: #1, #2, #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

iris score

Basis:

other: #1, #2, #3

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 21 days

Irritation parameter:

conjunctivae score

Basis:

other: #1, #2, #3

Time point:

24/48/72 h

Score:

1.67

Max. score:

3

Reversibility:

fully reversible within: 21 days

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.67

Max. score:

4

Reversibility:

fully reversible within: 28 days

Irritation parameter:

chemosis score

Basis:

animal #2

Remarks:

#2, #3

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 21 days

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2.3

Max. score:

4

Reversibility:

fully reversible within: 21 days

Irritant / corrosive response data:

All 3 animals showed moderate to strong ocular reaction 1 h after application of the test substance. 24 h after application slight to moderate ocular
reactions were observed in all three animals. Slight cornea opacity was observed in all animals 24 h after application. The cornea damage was not
further observed 48 h after treatment. Slight irritation of the conjunctivae and the iris persists within 14 days. At day 21 effects were fully reversible
with exception of chemosis (socre 1) in one animal, which was fully reversible after 28 days.

Other effects:

No symptoms of systemic toxicity were observed during the whole 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	1/2/1	2/4/3
24 h	1/1/1	1/1/1	2/2/2	2/2/4
48 h	0/0/0	1/1/1	2/2/2	2/2/2
72 h	0/0/0	1/1/1	1/1/1	1/2/1
7 days	0/0/0	1/1/0	1/1/1	1/1/1
14 days	0/0/0	1/0/0	1/1/1	1/1/1
21 days	0/0/0	0/0/0	0/0/0	1/0/0
28 days	0/0/0	0/0/0	0/0/0	0/0/0
Average 24h, 48h, 72h	0.33/0.33/0.33	1/1/1	1.67/1.67/1.67	1.67/2/2.3
Reversibility*)	c/c/c	c/c/c	c/c/c	c/c/c
Average time (unit) for reversion	48 hours	21 days	21 days	28 days

 

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

Interpretation of results:

Category 2A (irritating to eyes) based on GHS criteria

Conclusions:

Classification is based on effects on the cornea, iris and conjunctiva calculated as mean scores following grading at 24, 48 and 72 hours after instillation of the test material, in consideration of reversibility.
Classification Cat.2 for eye irritation is justified for the oleic acid-base TEA-Esterquat according to CLP, EU GHS (Regulation (EC) No 1272/2008).

Executive summary:

In a primary eye irritation study according to OECD Guideline 405, 2002 0.1 mL of the oleic acid-based TEA-Esterquat was instilled into the conjunctival sac of three New Zealand White rabbits. Animals then were observed for 28 days. Irritation was scored by the method stipulated by the OECD Guideline 405.

 

All 3 animals showed moderate to strong ocular reaction 1 h after application of the test substance. 24 h after application slight to moderate ocular reactions were still observed in all three animals. Slight cornea opacity was observed in all animals 24 h after application. The cornea damage was not further observed 48 h after treatment. Slight irritation of the conjunctivae and the iris persisted until day 14 in two animals and chemosis only until day 21 in one animal.. At day 21 effects were fully reversible with exception of a chemosis score 1 in one animal, which was fully reversible within 28 days.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation:

Four reliable primary dermal irritation studies (Klimisch 1) for oleic acid-based TEA-Esterquat are available, including two studies with diluted test substance.

The primary dermal irritation studies were performed according to OECD Guideline 404. Three New Zealand White rabbits were exposed to 0.5 mL of the undiluted oleic acid-based TEA-Esterquat for 4 hours to approximately 6 cm² of body surface area under semi-occlusive conditions. Irritation was scored by the method of Draize as stipulated in the OECD Guideline 404 at 24, 48 and 72 hours. Animals were observed for 14 days, or less if skin effects were reversible earlier.

In the two studies with concentrated test substance, erythematous lesions ranging from well defined erythema (grade 2) to marked erythema (grade 3), accompanied by edematic lesions ranging from very slight edema (grade 1), slight edema (grade 2) to moderate edema (grade 3) were observed at the 24, 48 and 72 hour readings. Dryness of the skin was observed in one study, only. Effects were reversible within the 14 day observation period. In one animal, light eschars were recorded at study termination at day 14. 

 

In the study with a test substance dilution of 28 %, only slight erythematous lesions (grade 2 and in most cases grade1) below the cut-off values for classification & labelling with decreasing intensity and no edema were observed at the 24, 48 and 72 hour readings. Effects were fully reversible within 7 days. 

 

Additional supporting results from a study conducted with diluted testsubstance (36.6 % in sesame oil) were considered to be not relevant. The evaluation was hampered due to limited specification information on the used test substance and the used vehicle sesame oil, which might have influenced the outcome of the study. 

 

In conclusion, oleic acid-based TEA-Esterquat is considered to be irritating to rabbit skin. In the study applying a concentration of 28 %, only slight erythema, clearly below the cut – off values for classification & labelling, were observed. These data are reliable to establish under CLP a specific concentration limit (SCL) of 28 % for the oleic acid-based TEA-Esterquat.

 

 

Eye irritation:

 

A total of four eye irritation studies are available for oleic acid-based TEA-Esterquat. The studies are in full compliance with OECD guideline 405, with exception of one study. This study was rated as ‘not reliable’ (Klimisch 3) because only one animal was tested, even though no corrosion was observed.

The other primary eye irritation studies were performed according to OECD Guideline 405. 0.1 mg of the test substance was instilled into the conjunctival sac of the eyes of 3 young adult New Zealand White rabbits. Irritation was scored by the method stipulated in the OECD guideline 405. Animals were observed for 28 days.

In the key study, slight to moderate ocular reactions were observed in all three animals. Slight cornea opacity was observed in all animals only within 24 hours after application. Slight irritation of the conjunctivae and the iris persists for 14 days. At day 21 effects were fully reversible with exception of a chemosis score 1 in one animal, which was fully reversible within 28 days.

In a supporting study, comparable results were observed. Due to study termination after 7 days, full reversibility of effects was not shown in one animal with a remaining score of 1 for conjunctival redness at study day 7. However, full reversibility can be expected, taken information from other TEA-Esterquat eye irritation studies into account.

 

In the study with a test substance dilution of 28 %, only slight reactions of the conjuctiva (grade 2 and in most cases grade1) below the cut-off values for classification & labelling with decreasing intensity were observed at the 24, 48 and 72 hour readings. No effects were observed on the cornea or iris. Conjunctival redness and chemosis were fully reversible within 7 days. 

 

In conclusion, oleic acid-based TEA-Esterquat is considered to be irritating to the rabbit eye. In the study with a concentration of 28 %, only slight effects of the conjunctiva below the cut – off values for classification & labelling were observed. These data are reliable to establish under CLP a specific concentration limit (SCL) of 28 % for the oleic acid-based TEA-Esterquat.

Respiratory irritation:

No data on the respiratory irritation of oleic acid-based TEA-Esterquat are available.

 

There are no data gaps for the endpoint irritation/corrosion. No human information is available for this endpoint. However, there is no reason to believe that these results would not be applicable to humans.

 

 

The source substances MDEA-Esterquat C16-18 and C18 unsatd. as well as partially unsaturated TEA-Esterquats are not classified for skin or eye irritation. These data are included into the dossier to complete the toxicological profiles of the source substances.

Justification for classification or non-classification

Based on the available data, the substance is classified as Skin Irritation Cat 2 (H315: Causes skin irritation) and Eye Irritation Category 2 (H319: Causes serious eye irritation) according to regulation (EC) 1272/2008.