Fatty acids, C8-18 (even numbered) and C18 unsatd., reaction products with triethanolamine, di-Me sulfate-quaternized

Endpoint summary

Description of key information

No studies on skin irritation are available for the target substance, but studies are available performed with the partially unsaturated TEA-Esterquat. The results of these evaluated studies draw a picture of slight to moderate skin irritation with scores scattered around the threshold values for classification. In addition, human studies with the partially unsaturated TEA-Esterquat revealed no evidence of a skin irritation response in humans.

For eye irritation no studies are available with the target substance, but from studies with the partially unsaturated TEA-Esterquat it can be concluded that the target substance will be not irritating in vivo.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation

Animal data

A total of 22 in vivo skin irritation studies applying the partially unsaturated TEA-Esterquat have been evaluated, including 3 studies with diluted test substances. 21 studies were of good quality performed according to OECD guideline 404. One study was evaluated 'not reliable´ (Klimisch 3) due to methodological deficiencies. Observation was not extended beyond 72 hours. The majority of the evaluated studies indicate slight to moderate skin irritation with max. scores scattered around the threshold values for classification. In a minority of three studies increased scores were observed, up to an erythema score of 3. There was no possibility to link these positive findings to specific chemical factors. To obtain the most adequate basis for decision with respect to classification and labeling, a sample of a partially unsaturated TEA-Esterquat - representative of current production practices - was tested.

In this primary dermal irritation study performed according to OECD Guideline 404, three New Zealand White rabbits were exposed to 0.5 g of the partially unsaturated TEA-Esterquat for 4 hours to approximately 6 cm² of body surface area under semi-occlusive conditions. Irritation was scored by the method as stipulated in the OECD Guideline 404. Animals were then 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. One animal showed only very slight, barely perceptible erythema and edema. 7 days after patch removal, very slight erythema and edema (grading 1) were still existent in two animals, which were reversible after 14 days. In addition, slight desquamation was observed in all three animals at observation time points 72 hours, 7 days and 14 days after application. 21 days after application, all three animals were without any sign of skin irritation.

Human data

In three studies, a total of 60 panelists were exposed to 1 to 10 % solutions of the partially unsaturated TEA-Esterquat for 24 hours under occlusive conditions. Slight and transient irritation indicated by the occurrence of erythema was observed in 5 of 60 panelists. In one of the studies, applying a 5 % test substance dilution, a skin irritation comparable to the water control was observed. Most likely this is the result of the extended 24-hour exposure and occlusive conditions. Two 30-minute open application studies conducted with a total of 40 volunteers, which were exposed to 10 % aqueous solutions of the partially unsaturated TEA-Esterquat, revealed no evidence of a skin irritation response in humans. (However, a quickly disappearing slight erythema was observed in two panelists.)

 

Conclusion

In conclusion, the results of the evaluated studies draw a picture of slight to moderate skin irritation with scores scattered around the threshold values for classification. A new study was conducted on the basis of a detailed described test substance. The results of this study confirm the observed effects of the other studies. The partially unsaturated TEA-Esterquat has not to be classified according to Regulation EC No 1272/2008. Human open application tests, reflecting more realistically the type of exposure humans are experiencing when using the partially unsaturated TEA-Esterquat, showed a very favorable skin compatibility profile indicated by an absence of a skin irritation response. Even under more severe exposure conditions such as 24-hrs occluded patch tests, the exposure to the partially unsaturated TEA-Esterquats in concentrations up to 10 % resulted in only mild and transient skin irritation, in some of the panelists.

Eye irritation

Animal data

A total of 23 in vivo eye irritation studies and one in vitro eye irritation study have been evaluated with the partially unsaturated TEA-Esterquat, including 3 studies with diluted test substances. 21 in vivo studies were of good quality performed according to OECD guideline 405. One study was performed according to US-guideline 16 CRF 1500.42, therefore these study was terminated after 72 hours. One study was evaluated ´not reliable´ (Klimisch 3) due to inconsistent results. The majority of the evaluated in vivo studies indicate slight to moderate eye irritation with scores clearly below the cut-off values for classification. In five of 18 guideline studies applying the undiluted test substance the observed scores were above the cut-off value and classification and labeling according to Regulation EC No 1272/2008 would be required. There was no possibility to link these positive findings to specific chemical factors.

To obtain the most adequate basis for decision with respect to classification and labeling, a sample of a partially unsaturated TEA-Esterquat - representative of current production practices - was tested.

In a primary eye irritation study conducted according to OECD Guideline 405, 0.1 mL of the test substance was instilled into the conjunctival sac eye of 3 young adult New Zealand White rabbits. Irritation was scored by the method stipulated in the OECD guideline 405. Animals were observed for 21 days. 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 persisted until 72 hours but was fully reversible 7 days after application in all three animals. In conclusion, the results of this newly conducted study reflect the outcome of the majority of the other studies. Whereas slight effects involving cornea and iris were observed only in some studies, slight effects on the conjunctiva were observed in most studies. Evaluation of 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.

In addition, there was no evidence for an eye irritating potential of the partially unsaturated TEA-Esterquat from a Hen´s egg Chorioallantoic Membrane Test (HET-CAM) in vitro eye irritation study.In this HET-CAM study, 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. 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.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008 

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. As a result the substance is not considered to be classified for skin/eye irritation under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/ 776.