Registration Dossier

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Diss Factsheets

Administrative data

Description of key information

Skin irritation
Not irritating to skin, OECD TG 404, in vivo, rabbit, RL1; GLP (4 h semiocclusive, intact skin; grade 1-2 edema + erythema; fully reversible within 14 d)


Eye irritation
Not irritating to eye, weight of evidence:
- OECD TG 405, in vivo, rabbit, RL1; GLP (slight to moderate ocular reactions, fully reversible within 7 d; not irritating to eyes)
- HET-CAM, in vitro, RL2; GLP (score: 0.67 of maximum 21; vascular injection on the CAM of 4 eggs 5 minutes post application; no other effect detected; not irritating)

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:
2010-04-12 to 2010-05-04
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:
2002
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
2008
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: The right flank remained untreated and served as a control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g undiluted
Duration of treatment / exposure:
4 hours
Observation period:
1 hour and 24, 48, 72 hours 7, 14 and 21 days after application of the test substance.
Number of animals:
3 animals, 1 male and 2 females
Details on study design:
TEST SITE
- Area of exposure: Samples of 0.5 g of the test substance have been put on a gauze pad and spread over an area of 2 cm x 3 cm; the gauze pad then was applied to the skin.
- % coverage: One gauze pad of 4 cm x 5 cm size (Askina® Brauncel, B. Braun Petzold GmbH, Melsungen, Germany) with test substance was applied to the left flank of one animal. It was held in place by strips of Micropore (3M company, St. Paul, USA). The semi-occlusive dressing was bandaged with Acrylastic (Beiersdorf AG, Hamburg, Germany) and fixed with Leukoplast (Beiersdorf AG, Hamburg, Germany).


REMOVAL OF TEST SUBSTANCE
- Washing (if done): after exposure skin was cleaned carefully with lukewarm water
- Time after start of exposure: 4 hours

SCORING SYSTEM: as stipulated by OECD guideline 404, 2002
Irritation parameter:
erythema score
Basis:
animal: #1, #2
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 14 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
Time point:
24/48/72 h
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
Symptoms of skin irritation (erythema and edema) were observed until 7 days after application. Well-defined erythema and slight edema formation
(grading 1 or 2 in each case) were observed within 72 hours after patch removal in two animals. In one animal only very slight, barely perceptible
erythema and edema occurred. 7 days after patch removal, very slight erythema and edema (grading 1) were still existent in two animals, which was
reversible after 14 days. In addition, slight desquamation was observed in all three animals at observations at 72 hours, 7 days and 14 days after
application. 21 days after application, all three animals were without any sign of skin irritation.

Other effects:
No symptoms of toxicity caused by the test substance or any unusual finding were observed.

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

Erythema

Edema

Max. score: 4

Max. score: 4

60 min

1/2/1

0/0/0

24 h

2/2/1

1/1/0

48 h

2/2/1

2/2/1

72 h

2/2/1

2/2/1

7 days

1/1/0

1/1/0

14 days

0/0/0

0/0/0

Average 24h, 48h, 72h

2/2/1

1.67/1.67/0.67

Reversibility*)

c/c/c

c/c/c

Average time (unit) for reversion

14 days

14 days

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

Desquamation persists at the 14 day observation, but was fully reversible at study day 21.

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 partially unsaturated TEA-Esterquat according to CLP, EU GHS (Regulation (EC) No 1272/2008).
Executive summary:

In a primary dermal irritation study performed according to OECD Guideline 404, three New Zealand White rabbits, were semi-occlusive dermally exposed to 0.5 g of the partially unsaturated TEA-Esterquat for 4 hours to approximately 6 cm² of body surface area. Irritation was scored by the method as stipulated by OECD Guideline 404. Animals were than observed for 21 days.

 

Symptoms of skin irritation (erythema and edema) were observed until 7 days after application. Well-defined erythema and slight edema formation (grading 1 or 2 in each case) were observed within 72 hours after patch removal in two animals. In one animal only very slight, barely perceptible erythema and edema occurred. 7 days after patch removal, very slight erythema and edema (grading 1) were still existent in two animals, which was reversible after 14 days. In addition, slight desquamation was observed in all three animals at observations at 72 hours, 7 days and 14 days after application. 21 days after application, all three animals were without any sign of skin irritation.

 

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2010-04-07 to 2010-04-19
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:
yes, concurrent no treatment
Amount / concentration applied:
0.1 mL test substance.
As the test substance is a firm solid paste it was melted in a water bath at 60 °C resulting in the formation of a smooth paste. Subsequently it was held at room temperature until it cooled down to 40 °C. Then 0.1 mL of the paste was applied by means of a syringe to the eye of one animal.
Observation period (in vivo):
1 hour and 24, 48, 72 hours and 7 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 #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal: #1, #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
animal: #2, #3
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 7 days
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 3 animals showed slight to moderate ocular reaction 1 hour after application of the test substance. After 24 hours slight to moderate ocular reactions were still observed in all three animals. Slight cornea opacity was observed in one animal at the 24 hour reading. The cornea damage was no longer observed 48 hours after treatment. Slight irritation of the conjunctivae persists until 72 hours but was fully reversible 7 days after application in all three animals.
Other effects:
No symptoms of systemic toxicity were observed during the whole study.
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 the partially unsaturated 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 partially unsaturated TEA-Esterquat 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.

All three animals showed slight to moderate 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 one animal 24 h after application. The cornea damage was not further observed 48 h after treatment. Slight irritation of the conjunctivae persists until 72 h but 7 days after application all three animals were without any sign of ocular irritation.

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2007-12-14
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Principles of method if other than guideline:
Hen's Egg Test on the Chorioallantoic Membrane (HET-CAM).
Test procedure based on publications by Prof. Dr. N.-P. Lüpke, Institute for Pharmacology and Toxicology, University of Münster (for example in H. Schöffl, Ersatz- und Ergänzungsmethoden zu Tierversuchen: Möglichkeiten und Grenzen der Reduktion von Tierversuchen, Springer Verlag, 1992) as laid down the Standard Operating Procedure (SOP) T 7 "Hühnerei-Test" of the test facility.
GLP compliance:
yes (incl. QA statement)
Species:
other: chicken eggs
Strain:
other: SPAFAS
Vehicle:
unchanged (no vehicle)
Controls:
other: refer to "details on study design"
Amount / concentration applied:
refer to "details on study design"
Duration of treatment / exposure:
refer to "details on study design"
Observation period (in vivo):
refer to "details on study design"
Number of animals or in vitro replicates:
refer to "details on study design"
Details on study design:
NUMBER OF EGGS
For the test substance 6 eggs were used.
For test validation 6 eggs each were inserted:
positive control: Texapon ASV 70 Spezial (as 5% active substance preparation)
negative control: tap water

INCUBATION OF EGGS
After delivery eggs were stored with blunt ends upwards at temperatures between 15°C and 22 °C to ensure that the air space is adjusted under the
blunt end.
The incubation of the eggs took place in an incubator with an automatic rotating device (Compact S 84, Firm Grumbach, 35614 Asslar, Germany) under continuous ventilation at a temperature of 37.5 °C (±0.5 °C) and a relative humidity of 62.5 % (±7.5 %). Temperature and humidity were recorded
every working day. The eggs were turned automatically every hour. No deviations from pre-set conditions were recorded during incubation period.
The whole incubation period amounted to 9 days. Up to this time point it can be expected that the embryo is insensitive to pain. From the 6th
incubation day on the eggs were illuminated every second day with a candeling lamp. Eggs, which were not fertilized or not developed, were rejected.

PREPARATION AND DOSAGE OF TEST SUBSTANCE
200 mg were detached from the test substance with a scalpel and an area of approximately 1 cm x 1 cm of the chorioallantoic membrane (CAM) was covered with it. To assure the evaluation of the treated CAM the test substance was detached with tweezers after 30 seconds, 2 minutes and 5 minutes, respectively, because the test substance hindered continuous observation of the CAM. After 30 seconds evaluation and 2 minutes evaluation the same area of the CAM was covered with the same test substance again.

STUDY CONDUCT
The test was carried out 9 days after insertion of the eggs into the incubator.
For testing the egg shell around the air space was peeled away and the now visible white egg membrane was wetted with physiological saline (not colder than room temperature).
After approximately 1 minute the saline was poured off and the membrane was carefully removed with forceps. Eggs which show small lesions or hemorrhages after preparation were not used for the test. To prevent cooling down of the eggs never more than two were removed from the incubator and were prepared.
Two prepared eggs were placed under a cold light lamp (KL 1500 LCD, Schott Glas, Wiesbaden, Germany) and immediately the test substance was
applied onto the CAM. After application of the test substance the blood vessels of the CAM were observed after 30 seconds, 2 minutes and 5 minutes. After application of the positive and negative control the blood vessels of the CAM were continuously observed over a period of 0.5, 2 respectively
5 minutes. Untreated areas served as control. After the end of the observation period the next two freshly prepared eggs were exposed to the test
substance in the same manner.

EVALUATION
Possible effects were scored in dependence on the time of the reaction. The first appearance of the effect was relevant for scoring and not the lasting of the effect. Every observed reaction was noted only once according to the scoring scheme presented below.

Reaction 30 seconds 2 minutes 5 minutes
Vascular
Injection 5 3 1

Haemorrhage 7 5 3

Coagulation 9 7 5

For every possible reaction the recorded scores were added up for each egg. The average of the determined scores of the tested eggs corresponds to the irritation index of the test substance. By means of the irritation index the test substance was classified in analogy to the Draize eye irritation test according to the evaluation scheme below:


Irritation index Classification
0 - 0.9 scores not irritating
1 - 4.9 scores slightly irritating
5 - 8.9 scores moderately irritating
9 - 21.0 scores strongly irritating





Irritation parameter:
in vitro irritation score
Remarks:
mean irritation score, mean of all eggs
Value:
0.67
Negative controls validity:
valid
Positive controls validity:
valid
Other effects / acceptance of results:
Treatment with the test substance resulted in the appearance of vascular injection on the CAM of 4 eggs 5 minutes post application. No other effect was detected after treatment (0.67 scores of total 21 possible scores).

Summary of the observed effects after application of the test substance partially unsaturated TEA-EQ onto the CAM

 

Egg-

Number

Vascular Injection appearance in min.

 

Haemorrhage

appearance in min.

 

Coagulation

appearance in min.

Sum

0.5

 

2

5

0.5

2

5

0.5

2

5

 

1

0

0

1

0

0

0

0

0

0

1

2

0

0

0

0

0

0

0

0

0

0

3

0

0

1

0

0

0

0

0

0

1

4

0

0

0

0

0

0

0

0

0

0

5

0

0

1

0

0

0

0

0

0

1

6

0

0

1

0

0

0

0

0

0

1

 

 

 

 

 

 

 

 

 

 

Mean: 0.67

 

 

 

Application of tap water onto the CAM showed no effects; the irritation index therefore was0 of 21 total possible scores.

Treatment with a 5 % active substance preparation of the reference substance Texapon ASV 70 Spezial resulted in an irritation index of 10.3 of 21 total possible scores.

For an anticipation of the irritation potentialin vivo,the results obtained with the TexaponASV 70 Spezial are taken into consideration. A 5% active substance preparation of TexaponASV 70 Spezial is known to be only slightly irritatingin vivo(INVITOX Protocol Number 96, 1994, p4). A 5 % active substance preparation of Texapon ASV 70 Spezial reached 10.3 of 21 total possible scores. From this it can be concluded test substance AE 425/03 will be not irritatingin vivoif the result obtained with the reference substance were taken into consideration.

Interpretation of results:
GHS criteria not met
Conclusions:
Treatment with the test substance resulted in the appearance of vascular injection on the CAM of 4 eggs 5 minutes post application. No other effect was detected after treatment (0.67 scores of total 21 possible scores). Thus, the test substance partially unsaturated TEA-EQ was graded as not irritating according to the evaluation scheme.
Executive summary:

In this hen's egg chorioallantoic membrane test (HET-CAM), an accepted alternative method to the Draize test, the potential to cause irritation upon first contact with eyes or mucous membranes was assessed by application of the test substance onto the chorioallantoic membrane (CAM). 200 mg of the test substance "partially unsaturated TEA-Esterquat" were applied to an area of approximately 1 cm x 1 cm of the chorioallantoic membrane (CAM) of six fertilized and incubated eggs, strain SPAFAS.

The occurrence of vascular injection, haemorrhage and coagulation was recorded 30 seconds, 2 minutes and 5 minutes after application.

 

To assure the evaluation of the treated CAM the test substance was detached with tweezers after 30 seconds, 2 minutes and 5 minutes, respectively, because the test substance hindered continuous observation of the CAM. After 30 seconds evaluation and 2 minutes evaluation the same area of the CAM was covered with the same test substance again.

 

Treatment with the test substance resulted in the appearance of vascular injection on the CAM of 4 eggs 5 minutes post application. No other effect was detected after treatment (0.67 scores of total 21 possible scores). Thus, the test substance "partially unsaturated TEA-Esterquat" was graded as not irritating according to the evaluation scheme.

 

Application of tap water onto the CAM showed no effects; the irritation index therefore was 0 of 21 total possible scores.

Treatment with a 5 % active substance preparation of the reference substance Texapon ASV 70 Spezial resulted in an irritation index of 10.3 of 21 total possible scores.

For an anticipation of the irritation potential in-vivo,the results obtained with the Texapon ASV 70 Spezial are taken into consideration. A 5% active substance preparation of Texapon ASV 70 Spezial is known to be only slightly irritating in-vivo (INVITOX Protocol Number 96, 1994, p4). A 5 % active substance preparation of Texapon ASV 70 Spezial reached 10.3 of 21 total possible scores. From this it can be concluded test substance "partially unsaturated TEA-Esterquat will be not irritating in-vivo if the result obtained with the reference substance were taken into consideration.

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 performed according to OECD Guideline 404, three New Zealand White rabbits, were semi-occlusive dermally exposed to 0.5 g of the partially unsaturated TEA-Esterquat for 4 hours to approximately 6 cm² of body surface area. Irritation was scored by the method as stipulated by OECD Guideline 404. Animals were than observed for 21 days.


Symptoms of skin irritation (erythema and edema) were observed until 7 days after application. Well-defined erythema and slight edema formation (grading 1 or 2 in each case) were observed within 72 hours after patch removal in two animals. In one animal only very slight, barely perceptible erythema and edema occurred. 7 days after patch removal, very slight erythema and edema (grading 1) were still existent in two animals, which was reversible after 14 days. In addition, slight desquamation was observed in all three animals at observations at 72 hours, 7 days and 14 days after application. 21 days after application, all three animals were without any sign of skin irritation.


 


 


 


Eye irritation


In a primary eye irritation study according to OECD Guideline 405, 2002 0.1 mL of partially unsaturated TEA-Esterquat 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.


All three animals showed slight to moderate 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 one animal 24 h after application. The cornea damage was not further observed 48 h after treatment. Slight irritation of the conjunctivae persists until 72 h but 7 days after application all three animals were without any sign of ocular irritation.


 


In a hen's egg chorioallantoic membrane test (HET-CAM), an accepted alternative method to the Draize test, the potential to cause irritation upon first contact with eyes or mucous membranes was assessed by application of the test substance onto the chorioallantoic membrane (CAM). 200 mg of partially unsaturated TEA-Esterquat were applied to an area of approximately 1 cm x 1 cm of the chorioallantoic membrane (CAM) of six fertilized and incubated eggs, strain SPAFAS.


The occurrence of vascular injection, haemorrhage and coagulation was recorded 30 seconds, 2 minutes and 5 minutes after application.


To assure the evaluation of the treated CAM the test substance was detached with tweezers after 30 seconds, 2 minutes and 5 minutes, respectively, because the test substance hindered continuous observation of the CAM. After 30 seconds evaluation and 2 minutes evaluation the same area of the CAM was covered with the same test substance again.


Treatment with the test substance resulted in the appearance of vascular injection on the CAM of 4 eggs 5 minutes post application. No other effect was detected after treatment (0.67 scores of total 21 possible scores). Thus, partially unsaturated TEA-Esterquat was graded as not irritating according to the evaluation scheme.


Application of tap water onto the CAM showed no effects; the irritation index therefore was 0 of 21 total possible scores.


Treatment with a 5 % active substance preparation of the reference substance Texapon ASV 70 Spezial resulted in an irritation index of 10.3 of 21 total possible scores.


For an anticipation of the irritation potential in-vivo,the results obtained with the Texapon ASV 70 Spezial are taken into consideration. A 5% active substance preparation of Texapon ASV 70 Spezial is known to be only slightly irritating in-vivo (INVITOX Protocol Number 96, 1994, p4). A 5 % active substance preparation of Texapon ASV 70 Spezial reached 10.3 of 21 total possible scores. From this it can be concluded that partially unsaturated TEA-Esterquat will be not irritating in vivo if the result obtained with the reference substance were taken into consideration.


 


 


 


 


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.