Registration Dossier

Administrative data

Description of key information

Four primary dermal irritation studies and four eye irritation studies for the oleic acid-based TEA-Esterquat are available.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Skin irritation:

Four reliable primary dermal irritation studies (Klimisch 1) for the 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, the 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 the 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, the 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.


Effects on skin irritation/corrosion: irritating

Effects on eye irritation: irritating

Justification for classification or non-classification

Skin irritation:

The oleic acid-based TEA-Esterquat is considered to be irritating to rabbit skin at higher concentrations. According to Directive 67/548 EEC as well as GHS Regulation EC No 1272/2008, the oleicacid-based TEA-Esterquat has to be classified as irritating to skin and needs to be labelled accordingly.

According to article 10 of GHS Regulation EC No 1272/2008, a specific concentration limit (SCL) is established, which is above the default concentration limit set for irritation in Part 2 of Annex I of this regulation. Reliable results (Klimisch 1) from a rabbit study according to OECD guideline 404 with a 28 % dilution of the oleic acid-based TEA-Esterquat show only a slight irritating potential (mean scores at 24, 48 and 72 hours were 0.67/1.33/1 for erythema; no edema was observed). According to Directive 67/548 EEC as well as GHS Regulation EC No 1272/2008, these values are well below the cut-off values for classification. Therefore, according to article 10 of GHS Regulation EC No 1272/2008, a specific concentration limit (SCL) for skin irritation of > 28 % is established for mixtures containing the oleic acid-based TEA-Esterquat. This implies, mixtures containing ≤ 28 % of the oleic acid-based TEA-Esterquat need not to be classified for skin irritation.

 

Eye irritation:

The oleic acid-based TEA-Esterquat is considered to be irritating to the rabbit eye at higher concentrations. According to Directive 67/548 EEC as well as GHS Regulation EC No 1272/2008, the oleic acid-based TEA-Esterquat has to be classified as irritating to eye and needs to be labelled accordingly.

According to article 10 of GHS Regulation EC No 1272/2008, a specific concentration limit (SCL) is established, which is above the default concentration limit set for irritation in Part 2 of Annex I of this regulation. Reliable results (Klimisch 1) from a rabbit eye irritation study according to OECD guideline 405 with a 28 % dilution of the oleic acid-based TEA-Esterquat show only a slight irritating potential of the conjunctiva (mean scores at 24, 48 and 72 hours for conjunctival redness 1.33/1.33/1.33 and for chemosis 0.33/0.33/0.33 were observed; no effects on cornea and iris). According to Directive 67/548 EEC as well as GHS Regulation EC No 1272/2008, these values are well below the cut-off values for classification. Therefore, according to article 10 of GHS Regulation EC No 1272/2008, a specific concentration limit (SCL) for eye irritation of > 28 % is established for mixtures containing the oleic acid-based TEA-Esterquat. This implies, mixtures containing ≤ 28 % of the oleic acid-based TEA-Esterquat need not to be classified for eye irritation.