Methyltrioctylammonium chloride

Endpoint summary

Description of key information

Skin Irritation:

Severe erythema and edema of the intact skin and the skin surrounding an abrasion after 24 and 72 hours was observed.

Hence, Methyl(trioctyl)azanium chloride can be considered to be irritating to rabbit skin.

Eye Irritation:

24 hour observation showed slight corneal opacity, slight iritis and severe conjunctival irritation for 0.1%w/v solution.

Observation on the seventh day showed 4 out of 5 rabbit eyes to be normal.

24 hour observation showed no corneal opacity or iritis for 0.01% w/v. One rabbit at 24 hours had slight irritation of the conjunctiva and slight discharge, but was normal on day 7.

It was concluded that if test chemical was used above 0.1% w/v solution in water, it causes irritation to eyes; but below 0.1%w/v solution in water no signs of irritation were reported.

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)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation:

In different studies,Methyl(trioctyl)azanium chloridehas been investigated for potential for dermal irritation to a greater or lesser extent. The studies are based on in vivo experiments in rabbits for the target chemical as well its structurally similar chemicals.

A study was performed to evaluate the skin irritation potential of Methyl(trioctyl)azanium chloride on rabbit skin. 0.5 ml technical grade compound was applied to the intact and abraded skin of 6 rabbits for 24 hours. The test sites were observed for erythema and edema at 24, 72 hours after exposure and scored according to Draize method.

Severe erythema and edema of the intact skin and the skin surrounding an abrasion after 24 and 72 hours was observed.

Hence, Methyl(trioctyl)azanium chloride can be considered to be irritating to rabbit skin.

Another study was performed in rabbits to determine the non-irritating concentration of Methyl(trioctyl)azanium chloride. 0.01 ml of the test chemical was applied to the skin of 5 rabbits and observed for effects. The dermal reactions were observed and scored according to method of Draize.

Severe edema and necrosis was observed. Individual irritation scores ranged from 6 to 10 with a mean of 8.3. Hence, Methyl(trioctyl)azanium chloride can be considered to be irritating to skin.

These results are further supported by similar study performed to determine the highest non-irritating concentration of Methyl(trioctyl)azanium chloride. 0.01 ml suspensions of 10%,1%,0.1%,0.01% (w/v) of the test chemical was applied to skin of 5 rabbits. Along with the test chemical 0.01 ml of water was also applied to the skin of rabbits. The rabbits were observed and scored for erythema, edema according the method of Draize. No signs of irritation were observed with water, whereas severe erythema, edema and slight necrosis was observed with 10% w/v suspension Individual irritation scores ranged from 4 to 8 with a mean of 5.7. Strong capillary injection, erythema and slight edema was observed with 1% w/v suspension. Individual irritation scores ranged from 0 to 5 with a mean of 1.7. Strong to slight capillary injection was observed with 0.1% w/v suspension. lndividual scores ranged from 0 to 2 with a mean of 0.3. Slight capillary injection was observed with 0.01% w/v suspension. Individual scores ranged from 0 to 1 with a mean of 0.1. Based on these observations, Methyl(trioctyl)azanium chloride was considered to be skin irritant.

The results of these 3 studies indicate a strong possibility of Methyl(trioctyl)azanium chloride to cause irritation to skin.

These results are also supported by the experimental performed on Sprague –Dawley rats to evaluate the skin irritation potential of the structurally similar chemical.

0.1, 0.3 and 0.6% (w/w) of the test material [which was equivalent to 0, 2, 6 and 12 mg/kg in water] was applied to the clipped backs of male and female Sprague Dawley rats for 6 hours under occlusion, 5 days/week, for 13 weeks. Skin irritant effects, such as epidermitis and dermatitis were observed in males at 12 mg/kg/day and in females at >6 mg/kg/day. Females at 12 mg/kg/day also experienced focal hemorrhages, vacuolar degeneration and ulceration of the skin. Both sexes at >6 mg/kg/day showed erythema and edema at the site of application during certain time periods of the study.

Hence, repeated exposure of the test chemical to rats was considered to cause irritation to skin.

The above results are supported by the experimental study conducted according to Draize method to evaluate the primary dermal irritation potential of the structurally similar chemical. Adult rabbits were used for the study. 0.5 ml of 25%, 2.5%, and 1.25% solutions of the test chemical was applied to clipped areas of intact and abraded rabbit skin. The treated areas were covered with gauze and wrapped to keep the test material in contact with the skin and to decrease the rate of vaporization. The wrapping and test material were removed 24 hours following application. The sites were examined and scored separately for erythema and edema at 24 and 72 hours. Primary dermal irritation indices were calculated according to the Draize procedure for 25%, 2.5%, and 1.25% concentrations of the material.

The mean scores for 24- and 72-hour readings were averaged to determine the irritation index. Primary irritation indices were calculated to be 6.0, 2.4, and 1.0 for the 25%, 1.25%, and 2.5% solutions, respectively.

Based on the primary irritation indices, the test chemical can be considered as mild irritant to skin.

Based on the results obtained from the above studies for the target as well as structurally similar read across chemicals, Methyl(trioctyl)azanium chloride can be considered to be irritating to skin.Comparing the above annotations with the criteria of CLP regulation,Methyl(trioctyl)azanium chloridecan be classified under the category “Category 2”.

Eye Irritation:

In different studies,Methyl(trioctyl)azanium chloridehas been investigated for potential for dermal irritation to a greater or lesser extent. The studies are based on in vivo experiments in rabbits for the target chemical as well its structurally similar chemicals.

 

The ocular irritation potential of Methyl(trioctyl)azanium chloride was evaluated in rabbits.

Single 24 hour application of 0.2 ml of 0.1%, 0.01% w/v solution in water was applied to one eye of each of 5 rabbits and observed for signs of irritation. The treated eyes were observed 24 hours after instillation till 7 days. 24 hour observation showed slight corneal opacity, slight iritis and severe conjunctival irritation for 0.1%w/v solution. Observation on the seventh day showed 4 out of 5 rabbit eyes to be normal.

24 hour observation showed no corneal opacity or iritis for 0.01% w/v. One rabbit at 24 hours had slight irritation of the conjunctiva and slight discharge, but was normal on day 7.

It was concluded that if test chemical was used above 0.1% w/v solution in water, it causes irritation to eyes; but below 0.1%w/v solution in water no signs of irritation were reported.

This is supported by the results of Draize tests conducted according to the OECD guidelines for the structurally similar chemical.

In the first validation, 100 ml aqueous solution or a suspension of 10% test chemical was applied to the right eyes of male New Zealand white rabbits (2.30±2.98 kg, 13 wk of age). Left eyes remained untreated as a control. Eyes were observed at 1 hr, 4 hr, and every 24 hr thereafter for 7 days. Three rabbits were used for test. MAS [Maximum average scores] and scores at 24 hr after application calculated for cornea, iris, conjunctivae and the sum of these scores (total average score) were used for comparison with in vitro data. According to the classification by Kay and Calandra (1962), chemicals can be classified as follows based on their MAS scores:

non-irritants = (0≤MAS <0.5), slight irritants = (0.5≤MAS< 15), mild irritants = (15≤MAS< 25), moderate irritants = (25≤MAS <50) and severe irritants  = (50≤MAS)

The Maximum Average Score[MAS] obtained for 10% test chemical was 91.3 after 7 days and the average scores after 24 hours was 56.3. According to the classification based on the MAS scores, the test chemical can be considered to be an eye irritant.

The above results are further supported by a study performed to determine the highest non irritating concentration of the other structurally similar chemical in rabbit.

0.06%, 0.125%, 0.25%,0.5% concentration of the test chemical were instilled into rabbit eyes and observed for signs of irritation(volume of dose, duration of exposure, observation period). Mild irritation was observed for 0.06%, moderate irritation and severe irritation were observed for 0.125%, 0.5 or 0.25% respectively.

Based on these observations, the test chemical was considered to be an eye irritant.

Based on the results obtained from the above studies for the target as well as structurally similar read across chemicals, Methyl(trioctyl)azanium chloride can be considered to be irritating to eyes.Comparing the above annotations with the criteria of CLP regulation,Methyl(trioctyl)azanium chloridecan be classified under the category “Category 2”.

Justification for classification or non-classification

Available results for Methyl(trioctyl)azanium chloride indicate that it is likely to cause irritation to eyes and skin.

Hence, Methyl(trioctyl)azanium chloride can be classified under the category “Category 2” as per CLP regulation.