N,N,N-tri-C8-C10-alkyl-N-methyl-1-aminium sulfate

Endpoint summary

Description of key information

Skin irritation:

OECD TG 439: irritant (Cat 1 or 2): mean relative tissue viability for the test item was below 50% after 15 ± 0.5 minutes treatment

OECD TG 431: not corrosive: mean viability 79.4% (after 3 min exposure) and 65.3% (after 60 min exposure)

Eye irritation:

ICE (OECD TG 438): irreversible damage:

moderate corneal swelling: mean = 23.6%; severe cornea opacity: severity 3 on one eye and severity 4 on two eyes; severe fluorescein retention: severity 3; slight loosening of epithelium in one eye at 240 minutes and severe loosening of epithelium in one eye at 120 minutes after the post-treatment rinse; the test item was stuck on all cornea surfaces after the post-treatment rinse; the cornea surfaces were not cleared at 240 minutes after the post-treatment rinse.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Reference 1

Endpoint:

skin corrosion: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

06.11.2019 - 11.04.2020

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)

GLP compliance:

yes (incl. QA statement)

Species:

other: EpiDerm™ (EPI-200-SCT, Lot no. 25899) MatTek In Vitro Life Science Laboratories, s.r.o, Mlynské Nivy 73, 821 05 Bratislava II, Slovak Republic.

Details on test animals or test system and environmental conditions:

EpiDerm™ is cultured from normal human keratinocytes.

Amount / concentration applied:

25 mg of test item were applied topically to the centre of the skin equivalent with a surface area of 0.63 cm2 by using a sharp spoon to uniformly cover the skin surface. The test item is a fine powder. For better contact of the test item to the skin, the skin surface was moistened with 25 μL sterile deionised water to ensure adequate contact with the skin.

Duration of treatment / exposure:

Quality control (Triton X-100, 1 % solution)
Positive control 3 min + 60 min (± 1 min) (8 N KOH)
Negative control 3 min + 60 min (± 1 min) (sterile deionised water)
Test substance 3 min + 60 min (± 1 min) undiluted

Number of animals:

The test was performed in duplicate.

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

Exposure: 3 min

Value:

ca. 79.4

Negative controls validity:

valid

Positive controls validity:

valid

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

exposure: 60 min

Value:

ca. 65.3

Negative controls validity:

valid

Positive controls validity:

valid

Exposure 3 min:

Test substance: mean viability 79.4 %

Negative control: mean viability 100 %

Positive control: mean viability 6.6 %

Exposure 60 min:

Test substance: mean viability 65.3 %

Negative control: mean viability 100 %

Positive control: mean viability 6.4 %

Interpretation of results:

GHS criteria not met

Conclusions:

Topical application of the test substance on top of the stratum corneum of the reconstructed human epidermis model EpiDerm™ (duplicate)
resulted in a mean cell viability of 79.4% (after 3 min exposure) and 65.3% (after 60 min exposure) when compared to the corresponding negative conrol. Under the present test conditions Quarternary ammonium compounds, tri-C8-C10-alkylmethyl, Me sulfates tested at two exposure periods of 3 minutes or 1 hour was non-cytotoxic and, hence, predicted to be non-corrosive to skin in an experiment employing an artificial three-dimensional model of human skin.

Executive summary:

The purpose of this study was to determine cytotoxic properties of Quarternary ammonium compounds, tri-C8-C10-alkylmethyl, Me sulfates to skin cells, which might lead to human skin corrosion, by using an artificial three-dimensional model of human skin. The EpiDermTM model was employed.

Duplicate tissues were used for each treatment and concurrent control groups. The optical density (OD) was determined by using the MTT (3-(4,5-Dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide, Thiazolyl blue) reduction assay and expressed

as relative percentage of viability of the negative control-treated tissues.

25 mg of test item were applied topically to the centre of the skin equivalent with a surface area of 0.63 cm2 by using a sharp spoon to uniformly cover the skin surface. The test item is a fine powder. For better contact of the test item to the skin, the skin surface was moistened with 25 μL sterile deionised water to ensure adequate contact with the skin. Sterile deionised water was used as the negative control. 8 N KOH was used as the positive reference item. An exposure time of 3 min and 60 minutes was employed.

The mean viability of cells exposed to Quarternary ammonium compounds, tri-C8-C10-alkylmethyl, Me sulfates was 79.4% (after 3 min exposure) and 65.3% (after 60 min exposure) of the negative controls and, hence, was above the cut-off percentage cell viability value that distinguishes corrosive from non-corrosive test items of > = 50%. Under the present test conditions Quarternary ammonium compounds, tri-C8-C10-alkylmethyl, Me sulfates tested at two exposure periods of 3 minutes or 1 hour was non-cytotoxic and, hence, predicted to be non-corrosive to skin in an experiment employing an artificial three-dimensional model of human skin.

Reference 2

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

04.03.2020 - 23.03.2020

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)

GLP compliance:

yes (incl. QA statement)

Species:

other: EPISKIN Small ModelTM (EPISKIN-SMTM, 0.38 cm2, Batch no.: 20 EKIN 012)

Details on test animals or test system and environmental conditions:

EpiSkin™ Small /Human Epidermis (SM/13) is cultured from normal human keratinocytes.

Amount / concentration applied:

an excessive amount of the test item was applied directly on top of the skin tissue using a filtration paper for 15 ± 0.5 minutes

Duration of treatment / exposure:

Positive control 15 min (± 0.5 min), 25 µL 5% SDS
Negative control 15 min (± 0.5 min), 25 µL PBS
Test substance 15 min (± 0.5 min), an excessive amount of the solid test item was added into 12-well plates on top of the skin tissues using a filtration paper

Observation period:

after washing process post incubation period of 42 h at 37°C

Number of animals:

The test was performed in triplicate

Irritation / corrosion parameter:

% tissue viability

Value:

ca. 7

Negative controls validity:

valid

Positive controls validity:

valid

Test substance: mean viability 7.0 %

Negative control: mean viability 100 %

Positive control: mean viability 8.4 %

Interpretation of results:

other: Irritant (I) (GHS Cat. I or Cat. II)

Conclusions:

In conclusion, the test item is an irritant in the in vitro skin irritation test under the experimental conditions described in this report and should be classified category 1 or category 2 according to the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) of the United Nations.

Executive summary:

The objective of this study was to evaluate PC-2019-853 for its ability to induce skin irritation on a human three dimensional epidermal model (EPISKIN Small model (EPISKIN-SM^TM)). The possible skin irritation potential of the test item was tested through topical application for 15 minutes.

The study procedures described in this report were based on the most recent OECD and EC guidelines.

Batch AE 153/19 of the test item was a light yellow solidified melt. Skin tissue was moistened with 5 µL of Milli-Q water and an excessive amount of the test item was applied directly on top of the skin tissue using a filtration paper for 15 ± 0.5 minutes. After a 42 hour post-incubation period, determination of the cytotoxic (irritancy) effect was performed. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT at the end of the treatment.

Skin irritation is expressed as the remaining cell viability after exposure to the test item. The relative mean tissue viability obtained after 15 ± 0.5 minutes treatment with the test item compared to the negative control tissues was 7%. Since the mean relative tissue viability for the test item was below 50% after 15 ± 0.5 minutes treatment it is considered to be irritant.

The positive control had a mean cell viability of 8.4% after 15 ± 0.5 minutes exposure. The absolute mean OD₅₇₀(optical density at 570 nm) of the negative control tissues was within the laboratory historical control data range. The standard deviation value of the percentage viability of three tissues treated identically was ≤ 16%, indicating that the test system functioned properly.

In conclusion, PC-2019-853 is irritant in the in vitro skin irritation test under the experimental conditions described in this report andshould be classified category 1 or category 2 according to the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) of the United Nations.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2020-03-24 to 2020-05-???

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 438 (Isolated Chicken Eye Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)

Version / remarks:

adopted 25 June 2018

Deviations:

no

GLP compliance:

yes

Specific details on test material used for the study:

The test item was applied in its original form, considered as 100% (UVCB).

Species:

chicken

Details on test animals or tissues and environmental conditions:

Strain of chicken: ROSS 308
Source: TARAVIS KFT. (Address: 9600 Sárvár, Rábasömjéni utca 129., Hungary)

Chicken heads were collected after slaughter in a commercial abattoir from chickens (approximately 7 weeks old) which are used for human consumption. Heads were collected by a slaughter house technician and heads transported to Charles River Laboratories Hungary Kft. at ambient temperature at the earliest convenience.

After collection, the heads were inspected for appropriate quality and wrapped with tissue paper moistened with saline, then placed in a plastic box which was closed (4-5 heads per box). The heads were received at Charles River Laboratories Hungary Kft. and processed within 2 hours of collection.

After removing the head from the plastic box, it was put on soft paper. The eyelids were carefully cut away with scissors, avoiding damaging the cornea. One small drop of 2% (w/v) fluorescein solution was applied onto the cornea surface for a few seconds and subsequently rinsed off with 20 mL physiological saline. Then the fluorescein-treated cornea was examined with a hand-held slit lamp or slit lamp microscope, with the eye in the head, to ensure that the cornea was not damaged (i.e. fluorescein retention and corneal opacity scores ≤ 0.5). If the cornea was in good condition, the eyeball was carefully removed from the orbit.

The eyeball was carefully removed from the orbit by holding the nictitating membrane with a surgical forceps, while cutting the eye muscles with bent scissors. Care was taken to remove the eyeball from the orbit without cutting off the optical nerve too short. The procedure avoided pressure on the eye while removing the eyeball from the orbit, in order to prevent distortion of the cornea and subsequent corneal opacity. Once removed from the orbit, the eye was placed onto damp paper and the nictitating membrane was cut away with other connective tissue. The prepared eyes were kept on the wet papers in a closed box so that the appropriate humidity was maintained.

Vehicle:

unchanged (no vehicle)

Remarks:

The test item was applied in its original form.

Controls:

yes, concurrent positive control

yes, concurrent negative control

Amount / concentration applied:

TEST MATERIAL
The test item was applied onto the centre of the cornea, taking care not to damage or touch the cornea. As the test item was sticky, an alternative treatment way was used: a thin even layer of test item (approximately 0.5 g) was spread on a disk of Parafilm and then placed onto the cornea surface to ensure a suitable exposure. The amount of the test item was enough to adequately expose the entire surface of the cornea.

Duration of treatment / exposure:

10 s

Observation period (in vivo):

eyes were examined at approximately 0, 30, 75, 120, 180 and 240 minutes after the post-treatment rinse

Number of animals or in vitro replicates:

Three test item treated eyes, three positive control treated eyes and one negative control eye were examined during the study.

Details on study design:

TEST PROCEDURE

Treatment:

After the zero reference measurements, the eye (in its retainer) was removed from the chamber, held in a horizontal position and the test item was applied onto the centre of the cornea, taking care not to damage or touch the cornea. As the test item was sticky, an alternative treatment way was used: a thin even layer of test item (approximately 0.5 g) was spread on a disk of Parafilm and then placed onto the cornea surface to ensure a suitable exposure. The amount of the test item was enough to adequately expose the entire surface of the cornea.

The positive control eyes were treated in a similar way with 30 mg powdered Imidazole. The negative control eye was treated with 30 µL of physiological saline (0.9% (w/v) NaCl solution).

Three test item treated eyes, three positive control treated eyes and one negative control eye were examined during the study.


Test item removal:

The time of application was noted, then after an exposure period of 10 seconds from the end of the application the cornea surface was rinsed thoroughly with 20 mL physiological saline solution at ambient temperature, taking care not to damage the cornea but attempting to remove all residual test material if possible.

Additional gentle rinsing with 3x20 mL saline was performed at each time point when the test material or the positive control material remaining on the cornea was observed.

Note: Physiological saline (Manufacturer: B. Braun Pharmaceuticals SA, Lot number: 194948162, Expiry date: 30 November 2022) was used for rinsing.
 

OBSERVATION

Observation and assessment of corneal effects:

The control eyes and test eyes were evaluated pre-treatment and at approximately 30, 75, 120, 180 and 240 minutes after the post-treatment rinse. Minor variations within approximately ±5 minutes were considered acceptable.

Corneal thickness and corneal opacity were measured at all time points. Fluorescein retention was measured on two occasions, at baseline (t=0) and approximately 30 minutes after the post-treatment rinse. Haag-Streit Bern 900 slit-lamp microscope was used for the measurements.

Morphological effects include “pitting” of corneal epithelial cells, “loosening” of epithelium, “roughening” of the corneal surface and “sticking” of the test substance to the cornea. These findings can vary in severity and may occur simultaneously. The classification of these findings is subjective according to the interpretation of the investigator.

Irritation parameter:

percent corneal swelling

Run / experiment:

100%, up to 75 min

Value:

8.8

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

positive indication of irritation

Irritation parameter:

cornea opacity score

Run / experiment:

100%

Value:

3.67

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

positive indication of irritation

Irritation parameter:

fluorescein retention score

Run / experiment:

100%

Value:

3

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

positive indication of irritation

Irritation parameter:

percent corneal swelling

Run / experiment:

100%, up to 240 min

Value:

23.6

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

positive indication of irritation

Other effects / acceptance of results:

TEST ITEM

Observation Value ICE Class
Mean maximum corneal swelling at up to 75 min 8.8 % II
Mean maximum corneal swelling at up to 240 min 23.6 % III
Mean maximum corneal opacity change 3.67 IV
Mean fluorescein retention change 3.00 IV
Other Observations Slight loosening of epithelium was observed in one eye at 240 minutes and severe loosening of epithelium was observed in one eye at 120 minutes after the post-treatment rinse. Test item was stuck on all cornea surfaces after the post-treatment rinse. The cornea surfaces were not cleared at 240 minutes after the post-treatment rinse.
Overall ICE Class 1xIII 2xIV

Based on this in vitro eye irritation study in isolated chicken eyes with PC-2019-853, the test item was classified as severe irritant according to the EU regulations. GHS Classification: Category 1.


POSITIVE CONTROL

Observation Value ICE Class
Mean maximum corneal swelling at up to 75 min 9.2% II
Mean maximum corneal swelling at up to 240 min 20.1% III
Mean maximum corneal opacity change 4.00 IV
Mean fluorescein retention change 3.00 IV
Other Observations Imidazole was stuck on all cornea surfaces after the post-treatment rinse. The cornea surfaces were not cleared at 240 minutes after the
post-treatment rinse.
Overall ICE Class 1xIII 2xIV

Based on these observations, the positive control substance Imidazole was classified as severe irritant according to the EU regulations. GHS Classification: Category 1.


NEGATIVE CONTROL

Observation Value ICE Class
Mean maximum corneal swelling at up to 75 min 0.0% I
Mean maximum corneal swelling at up to 240 min 0.0% I
Mean maximum corneal opacity change 0.00 I
Mean fluorescein retention change 0.00 I
Other Observations None
Overall ICE Class 3xI

The negative control Physiological saline was classified as non-irritating, according to the EU regulations. GHS Classification: No Category.


VALIDITY OF THE TEST

The results from all eyes used met the quality control standards. The negative control and positive control results were within the historical data range. This study was considered to be valid.

SUMMARY TABLE FOR UN GHS CLASSIFICATION

 

Criteria for “No category” (all true)
3 endpoints classed as I or 2 endpoints classed as I and 1 endpoint classed as II or 1 endpoint classed as I and 2 endpoints classed as II:	False
No severe corneal morphological changes:	False
Test item was not stuck to the cornea at 240 minutes after the post-treatment rinse:	False

 

Criteria for “Category 1” (one or more true)
2 or more endpoints classed as IV:	True
Corneal opacity ≥ 3 at 30 min (in at least 2 eyes):	False
Corneal opacity = 4 at any time point (in at least 2 eyes):	True
Severe loosening of epithelium (in at least 1 eye):	True

 

Criteria for “No prediction can be made” (one or two true)
Based on the endpoints not classifiable for No Category, or for Category 1:	False
Particles of test item were stuck to the cornea and could not be washed off during the study:	True

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Conclusions:

Based on this in vitro eye irritation assay in isolated chicken eyes with PC-2019-853, the test item was severely irritant, UN GHS classification: Category 1.

Executive summary:

An in vitro eye irritation study of the test item was performed in isolated chicken’s eyes. The irritation effects of the test item were evaluated according to the OECD
No. 438 guideline (25 June 2018).

 

After the zero reference measurements, the eye was held in horizontal position and 0.5 g oftest itemwas applied onto the centre of the cornea such that the entire surface of the cornea was covered (due to the physical nature of the test item an alternative treatment way was used). After 10 seconds exposure time, the surface of the eyes was rinsed with physiological saline solution. Three eyes were treated with test item. The three positive control eyes were treated with 30 mg powdered Imidazole. The negative control eye was treated with 30 µL of physiological saline (0.9% (w/v) NaCl solution). Corneal thickness, corneal opacity and fluorescein retention were measured and any morphological effects (e.g. pitting or loosening of the epithelium) were evaluated.

 

The results from all eyes used in the study met the quality control standards. The negative control and positive control results were within the historical control data range in experiment. Thus, the study was considered to be valid.

Moderate corneal swelling change (mean = 23.6%) was observed during the four-hour observation period on test item treated eyes. Severe cornea opacity change (severity 3 on one eye and severity 4 on two eyes) was observed. Severe fluorescein retention change (severity 3) was noted on three eyes.Slight loosening of epithelium was observed in one eye at 240 minutes and severe loosening of epithelium was observed in one eye at 120 minutes after the post-treatment rinse.Test item was stuck on all cornea surfacesafter the post-treatment rinse. The cornea surfaces were not cleared at 240 minutes after the post-treatment rinse.

Based on this in vitro eye irritation assay in isolated chicken eyes with PC-2019-853, the test item was severely irritant,UN GHSclassification: Category 1.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation

The objective of this study was to evaluate Quaternary ammonium compounds, tri-C8-C10-alkylmethyl, Me sulfates for its ability to induce skin irritation on a human three dimensional epidermal model (EPISKIN Small model (EPISKIN-SMTM)). The possible skin irritation potential of the test item was tested through topical application for 15 minutes.

The study procedures described in this report were based on the most recent OECD and EC guidelines.

Skin tissue was moistened with 5 µL of Milli-Q water and an excessive amount of the test item was applied directly on top of the skin tissue using a filtration paper for 15 ± 0.5 minutes. After a 42 hour post-incubation period, determination of the cytotoxic (irritancy) effect was performed. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT at the end of the treatment.

Skin irritation is expressed as the remaining cell viability after exposure to the test item. The relative mean tissue viability obtained after 15 ± 0.5 minutes treatment with the test item compared to the negative control tissues was 7%. Since the mean relative tissue viability for the test item was below 50% after 15 ± 0.5 minutes treatment it is considered to be irritant.

The positive control had a mean cell viability of 8.4% after 15 ± 0.5 minutes exposure. The absolute mean OD570(optical density at 570 nm) of the negative control tissues was within the laboratory historical control data range. The standard deviation value of the percentage viability of three tissues treated identically was ≤ 16%, indicating that the test system functioned properly.

In conclusion, the test item is irritant in the in vitro skin irritation test under the experimental conditions described in this report and should be classified category 1 or category 2 according to the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) of the United Nations.

 

The purpose of this study was to determine cytotoxic properties of Quaternary ammonium compounds, tri-C8-C10-alkylmethyl, Me sulfates to skin cells, which might lead to human skin corrosion, by using an artificial three-dimensional model of human skin. The EpiDermTM model was employed.

Duplicate tissues were used for each treatment and concurrent control groups. The optical density (OD) was determined by using the MTT (3-(4,5-Dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide, Thiazolyl blue) reduction assay and expressed as relative percentage of viability of the negative control-treated tissues.

25 mg of test item were applied topically to the centre of the skin equivalent with a surface area of 0.63 cm2 by using a sharp spoon to uniformly cover the skin surface. The test item is a fine powder. For better contact of the test item to the skin, the skin surface was moistened with 25 μL sterile deionised water to ensure adequate contact with the skin. Sterile deionised water was used as the negative control. 8 N KOH was used as the positive reference item. An exposure time of 3 min and 60 minutes was employed.

The mean viability of cells exposed to Quaternary ammonium compounds, tri-C8-C10-alkylmethyl, Me sulfates was 79.4% (after 3 min exposure) and 65.3% (after 60 min exposure) of the negative controls and, hence, was above the cut-off percentage cell viability value that distinguishes corrosive from non-corrosive test items of > = 50%. Under the present test conditions Quaternary ammonium compounds, tri-C8-C10-alkylmethyl, Me sulfates tested at two exposure periods of 3 minutes or 1 hour was non-cytotoxic and, hence, predicted to be non-corrosive to skin in an experiment employing an artificial three-dimensional model of human skin.

 

Overall, Quaternary ammonium compounds, tri-C8-C10-alkylmethyl, Me sulfates is classified as Category 2 (irritant).

 

Eye irritation

An in vitro eye irritation study of the test item was performed in isolated chicken’s eyes. The irritation effects of the test item were evaluated according to the OECD No. 438 guideline (25 June 2018).

After the zero reference measurements, the eye was held in horizontal position and 0.5 g of the test item was applied onto the centre of the cornea such that the entire surface of the cornea was covered (due to the physical nature of the test item an alternative treatment way was used). After 10 seconds exposure time, the surface of the eyes was rinsed with physiological saline solution. Three eyes were treated with test item. The three positive control eyes were treated with 30 mg powdered Imidazole. The negative control eye was treated with 30 µL of physiological saline (0.9% (w/v) NaCl solution). Corneal thickness, corneal opacity and fluorescein retention were measured and any morphological effects (e.g. pitting or loosening of the epithelium) were evaluated.

 

The results from all eyes used in the study met the quality control standards. The negative control and positive control results were within the historical control data range in experiment. Thus, the study was considered to be valid.

Moderate corneal swelling change (mean = 23.6%) was observed during the four-hour observation period on test item treated eyes. Severe cornea opacity change (severity 3 on one eye and severity 4 on two eyes) was observed. Severe fluorescein retention change (severity 3) was noted on three eyes. Slight loosening of epithelium was observed in one eye at 240 minutes and severe loosening of epithelium was observed in one eye at 120 minutes after the post-treatment rinse. The test item was stuck on all cornea surfaces after the post-treatment rinse. The cornea surfaces were not cleared at 240 minutes after the post-treatment rinse.

Based on this in vitro eye irritation assay in isolated chicken eyes with Quaternary ammonium compounds, tri-C8-C10-alkylmethyl, Me sulfates, the test item was severely irritant, UN GHS classification: Category 1.

 

Respiratory irritation

No data on the respiratory irritation of Stearic acid 3-(dimethylaminopropyl)amide 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.

Justification for classification or non-classification

Skin irritation

Based on reliable, adequate and relevant data, Quaternary ammonium compounds, tri-C8-C10-alkylmethyl, Me sulfates is classified as Category 2 (irritant) according to teh criteria outlined in regulation (EC) 1272/2008 and assigned the hazard statement H315 and the signal word "warning" .

 

Eye irritation

Based on reliable, adequate and relevant data, Quaternary ammonium compounds, tri-C8-C10-alkylmethyl, Me sulfates has to be classified in Category 1, irreversible effects on the eye according to CLP, EU GHS (Regulation (EC) No 1272/2008) and is assigned the hazard statement H318 and the signal word “Danger”.