Fatty acids, C16-18, reaction products with triethanolamine, di-Me sulfate-quaternized

Endpoint summary

Description of key information

Skin irritation
Not irritating to skin, OECD TG 404, in vivo, rabbit, RL1; GLP (4 h semiocclusive, intact skin; no signs of irritationd)

Eye irritation
Not irritating to eye, OECD TG 405, in vivo, rabbit, RL1; GLP (slight to moderate ocular reactions, fully reversible within 21 d; not irritating to eyes)

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2002-01-29 to 2002-02-08

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

1992

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:

other: unchanged, moistened in 0.3 mL deionized water

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution):0.5 g fully saturated TEA-EQ, hardened moistened in 0.3 mL deionized water

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

Number of animals:

3 animals

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: the substance was evenly distributed over the whole surface of a 2.5 x 2.5 cm cellulose patch on a piece of surgical plaster, the plaster was fixed to the skin area and then covered with a semi-occlusive bandage.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with warm tap water
- Time after start of exposure:after the exposure period


SCORING SYSTEM: according to Draize

Irritation parameter:

erythema score

Basis:

animal: #1, #2, #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

edema score

Basis:

animal: #1, #2, #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

No signs of irrtations were observed during the study.

Other effects:

No clinical signs of systemic toxicity were observed.

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 fully saturated 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 g of the “fully saturated TEA-Esterquat” for 4 hours to approximately 6 cm² of body surface area. Animals then were observed for 72 hours. Irritation was scored by the method of Draize as stipulated by OECD Guideline 404.

No signs of irritation occurred during the whole observation period. No clinical signs of systemic toxicity were observed.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2010-05-04 to 2010-05-25

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 g test substance.
As the test substance is a solid it was crushed with a spatula to obtain small pieces and was furthermore finely ground in a mortar. The resulting fine white powder was then applied as such.

Duration of treatment / exposure:

1 hour after treatment the treated eye was rinsed with 0.9 % saline solution to remove remaining test substance from the eye.

Observation period (in vivo):

1 hour and 24, 48, 72 hours and 7, 14 and 21 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:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with 0.9 % % saline solution
- Time after start of exposure: 1 hour after exposure

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

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 21 days

Irritation parameter:

cornea opacity score

Basis:

animal: #2, #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 21 days

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Max. score:

2

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 21 days

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.67

Max. score:

3

Reversibility:

fully reversible within: 14 days

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 14 days

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 21 days

Irritation parameter:

chemosis score

Basis:

animal: #2, #3

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 14 days

Irritant / corrosive response data:

All 3 animals showed moderate ocular reaction 1 h after application of the test substance. 24 h after application slight to moderate ocular reactions
were observed in two animals while the third animal showed still strong ocular irritation. Only in this animal distinct cornea damage was observed
24 h after application. The cornea damage declined with time and was not further observed on day 21 after treatment. Slight irritation of the
conjunctivae persists until day 7 or day 14 after treatment but 21 days after application all three animals were without any sign of ocular irritation.

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	2/2/2	3/2/2
24 h	3/0/0	1/1/0	2/2/1	4/1/1
48 h	3/0/0	1/0/0	2/1/1	3/1/1
72 h	3/0/0	1/0/0	2/1/1	2/1/1
7 days	3/0/0	1/0/0	2/1/1	2/1/0
14 days	1/0/0	1/0/0	2/0/0	1/0/0
21 days	0/0/0	0/0/0	0/0/0	0/0/0
Average 24h, 48h, 72h	3/0/0	1/0.33/0	2/1.67/1	3/1/1
Reversibility*)	c/c/c	c/c/c	c/c/c	c/c/c
Average time (unit) for reversion	21 days	21 days	21 days	21 days

 

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

 

Interpretation of results:

GHS criteria not met

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 fully saturated TEA-EQ 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 g of the fully saturated TEA-EQ was instilled into the conjunctival sac of three New Zealand White rabbits. Animals then were observed for 21 days. Irritation was scored by the method stipulated by the OECD Guideline 405.

 

All 3 animals showed moderate ocular reaction 1 h after application of the test substance. 24 h after application slight to moderate ocular reactions were observed in two animals while the third animal showed still strong ocular irritation. Only in this animal distinct cornea damage was observed 24 h after application. The cornea damage declined with time and was not further observed on day 21 after treatment. Slight irritation of the conjunctivae persists until day 7 or day 14 after treatment but 21 days after application all three animals were without any sign of ocular irritation.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation

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 g of fully saturated TEA-Esterquat for 4 hours to approximately 6 cm² of body surface area. Animals then were observed for 72 hours. Irritation was scored by the method of Draize as stipulated by OECD Guideline 404. 

No signs of irritation occurred during the whole observation period. No clinical signs of systemic toxicity were observed.

 

 

Eye irritation

In a primary eye irritation study according to OECD Guideline 405, 2002 0.1 g of the fully saturated TEA-EQ was instilled into the conjunctival sac of three New Zealand White rabbits. Animals then were observed for 21 days. Irritation was scored by the method stipulated by the OECD Guideline 405.  

All 3 animals showed moderate ocular reaction 1 h after application of the test substance. 24 h after application slight to moderate ocular reactions were observed in two animals while the third animal showed still strong ocular irritation. Only in this animal distinct cornea damage was observed 24 h after application. The cornea damage declined with time and was not further observed on day 21 after treatment. Slight irritation of the conjunctivae persists until day 7 or day 14 after treatment but 21 days after application all three animals were without any sign of ocular irritation.

 

 

Respiratory irritation

No data on the respiratory irritation of partially unsaturated 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.

 

 

Similar results were obtained with the source substance MDEA-Esterquat C16-18 and C18 unsatd.: The substance is not classified for skin or eye irritation. These data are included into the dossier to demonstrate, that both substances have a similar toxicological profile.

 

Justification for classification or non-classification

Based on the available data, the substance does not need to be classified for skin and eye irritation according to regulation (EC) 1272/2008. Thus, no labelling is required.