p-anisylamine

Endpoint summary

Description of key information

Acute oral toxicity:

Data available for the structurally similar read across chemicals has been reviewed to determine the acute oral toxicity of the test chemical 4-Methoxybenzylamine (2393-23-9).The studies are as mentioned below:

1.Acute oral toxicity study was performed in male and female Sprague Dawley rats[Crj: CD (SD) ]

using test material test chemical.Distilled water was used as vehicle.Preliminary test was also done.No mortality was observed at dose 300 mg/kg bw.Animals were examined for clinical signs,histopathology, changes in body weight and organ weights.In clinical signs observation,No abnormal symptoms were observed in any of the control groups.In the 200 mg / kg group, a staggering walking, salivation, lacrimation and the like were observed from about 15 minutes after the administration, but in 2 hours after the administration, there was only a decrease in locomotor activity in one males, and other symptoms It disappeared. On the first day after the administration, contamination of the lower abdomen was observed in 2 females, but no abnormal symptoms were observed in any of the males and females after 2 days from the administration.In the 300 mg / kg group, immediately after administration, prone and breathing slowed, salivation from about 5 to 20 minutes after the administration, staggering walking and the like were observed, but disappeared at 2 hours after administration. Spontaneous exercise reduction and epidermal decline were observed after 2 hours from the administration, and the locomotor activity reduction continued even 6 hours after the administration. On the first day after administration, females showed dirt on the lower abdomen and brown urine, but no abnormal symptoms were observed in any of the males and females after 2 days from the administration.In body weight examination,each group of male and female rats showed almost the same trend as the control group, and no significant difference was observed. In the surviving cases, there was no remarkable change in gross pathological examination.Hence, Thelethal concentration (LD50) valuefor acute oral toxicity test was considered to be >300mg/kg bw,when male and female Sprague Dawley rats were treated with test chemical orally via gavage.The lethal concentration (LD50) value for acute oral toxicity test was considered to be >300mg/kg bw,when male and female Sprague Dawley rats [Crj: CD (SD)]were treated with test chemical orally via gavage.

2.Acute oral toxicity study was performed in male and female Sprague Dawley rats[Crj: CD (SD)]

using test material test chemical.Preliminary test was also done.Dead cases were observed in the group of 500 mg / kg or more when using corn oil as a medium. The death occurred about 6 hours after administration in one each sex of the 2000 mg / kg group. On the other hand, in other cases in the 2000 mg / kg group, sexes in the 1300 and 800 mg / kg group and 1 female in the 500 mg / kg group were one day after administration. Only one male in the 500 mg / kg group was dead on 2 days after administration.There was almost no weight gain on the first day after administration. In death cases, symptoms such as wiggle walking, salivation, rare lacrimation after death, then abdomen, epidermal warming,respiratory depression, cyanosis were observed. At autopsy, it was thought that the cause of death was due to circulatory disorder, as dark reddening of lung was observed in almost all cases. At necropsy, there were many cases of pleural effusion in 800 and 1300 mg / kg group, but in 2000 mg /kg group it was less, but the death time in 2000 mg / kg group was lower than that in other group.Hence,LD50 value was considered to be 526 mg/kg bw(95% confidence limit:385 - 686),when

male and female Sprague Dawley rats[Crj: CD (SD)] were treated with test chemical orally via gavage.

3.Acute oral toxicity study was performed in mouse using test material test chemical.50% mortality was observed at dose 500 mg/kg bw. Hence,LD50 value was considered to be 500 mg/kg bw,when mouse were treated with test chemical orally.

Thus, based on the above summarised studies,4-Methoxybenzylamine (2393-23-9) and it’s structurally similar read across substance, it can be concluded that LD50 value is between 300-2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation,4-Methoxybenzylamine (2393-23-9) can be classified as “Category IV” for acute oral toxicity.Hence,based on the data available for the structurally similar read across, test chemical 4-Methoxybenzylamine (2393-23-9)is likely to be toxic in the dose range of >300-526 mg/kg bw.

Acute inhalation toxicity:

(4-methoxyphenyl)methanamine has very low vapor pressure of 0.2 mm Hg at 50°C, so the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore this end point for acute inhalation toxicity by inhalation route is considered for waiver.

Acute dermal toxicity:

The substance 4-methoxyphenyl)methanamine is considered to be corrosive to skin. No acute dermal toxicity studies for the target chemical are available based on the corrosive nature of the test chemical. Based on these considerations, the end point for acute dermal toxicity is considered as waiver.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Remarks:

experimental data of read across substances

Justification for type of information:

Data for the target chemical is summarized based on the structurally similar read across chemicals

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

WoE report is based on two acute oral toxicity studies as-
1., 2. and 3. Acute Oral toxicity test was carried out to study the effects of the test chemicals on rodents

GLP compliance:

not specified

Test type:

other: no data available

Limit test:

no

Species:

other: 1. rat 2. rat 3.mouse

Strain:

other: 1.Sprague-Dawley[Crj: CD (SD)] 2.Sprague-Dawley[Crj: CD (SD)] 3.not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

1.Details on test animal
TEST ANIMALS
- Source: Charles River Japan Co., Ltd.
- Age at study initiation: 4 weeks
- Weight at study initiation: The body weight range on the 2nd day after acquisition was 84 to 106 g for males and 78 to 95 g for females.
- Fasting period before study:19 hours
- Housing: stainless steel suspended cage (W: 240 × D: 380 × H: 200 mm) to keep up to 5 animals per cage, They were bred individually using a continuous cage (W: 755 × D: 210 × H: 170 mm). Replacement of the cage dish and water bottle was done more than twice a week, and the cage and feeder was changed more than once every 2 weeks.
- Diet (e.g. ad libitum): solid feed
- Water (e.g. ad libitum): Drinking water freely consumed tap water using a water supply bottle.
- Acclimation period:2-day

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 24 °C.
- Humidity (%):40 to 70 %
- Air changes (per hr): 12 times / hour.
- Photoperiod (hrs dark / hrs light): 12 hours


2.Details on test animal
TEST ANIMALS
- Source: Charles River Japan Co., Ltd.
- Age at study initiation: 4 weeks
- Weight at study initiation: The body weight range on the 2nd day after acquisition was 84 to 106 g for males and 78 to 95 g for females.
- Fasting period before study:19 hours
- Housing: stainless steel suspended cage (W: 240 × D: 380 × H: 200 mm) to keep up to 5 animals per cage, They were bred individually using a continuous cage (W: 755 × D: 210 × H: 170 mm). Replacement of the cage dish and water bottle was done more than twice a week, and the cage and feeder was changed more than once every 2 weeks.
- Diet (e.g. ad libitum): solid feed
- Water (e.g. ad libitum): Drinking water freely consumed tap water using a water supply bottle.
- Acclimation period:2-day

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 24 °C.
- Humidity (%):40 to 70 %
- Air changes (per hr): 12 times / hour.
- Photoperiod (hrs dark / hrs light): 12 hours


3.No data available

Route of administration:

oral: gavage

Vehicle:

other: 1.distilled water 2.corn oil 3.not specified

Details on oral exposure:

1.Details on exposure:
VEHICLE
- Concentration in vehicle: 200 and 300 mg / kg in distilled water
- Amount of vehicle (if gavage): distilled water:20 ml/kg

MAXIMUM DOSE VOLUME APPLIED:300 mg/kg bw


2.details on exposure:
VEHICLE
- Concentration in vehicle:
200, 300, 500, 800,1300 and 2000 mg / kg
- Amount of vehicle (if gavage):10ml/kg
- Justification for choice of vehicle: Corn oil was used as a medium, Since the test substance is slightly soluble in water.

MAXIMUM DOSE VOLUME APPLIED:2000 mg/kg bw

DOSAGE PREPARATION (if unusual): The test substance was weighed and dissolved in corn oil or distilled water to prepare the required concentration of administration sample solution at the time of use.


3.no data available

Doses:

1.0,200, 300 mg / kg bw
2.0,200, 300, 500, 800,1300 and 2000 mg / kg bw
3.500 mg/kg bw

No. of animals per sex per dose:

1.Groups of 5 male and 5 females (per sex/dose) were used
2.Groups of 5 male and 5 females (per sex/dose) were used
3.No data available

Control animals:

yes

Details on study design:

1.Details on study design
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
General condition:
The general condition and the presence or absence of death were observed once a day until the administration day and 6 hours after administration (30 minutes after administration, 2, 4 and 6 hours after administration) before administration and during the observation period from the day after administration .

Weight measurement:
Measurement was made on the administration day (immediately before administration) and 1, 3, 7, 10 and 14 days after administration in the morning.

Autopsy:
The dead animals were necropsied promptly after discovery. At the end of the observation period, the surviving animals were sacrificed by exsanguination from the abdominal aorta under ether anesthesia and then necropsied, and findings were recorded. A control group of lung abnormalities is accepted lung and its comparison with autopsy, after taking a picture for a representative example, and fixed and stored in 10% neutral buffered formalin.

Histopathological examination:
Of the animals that survived for more than 24 hours after administration, the lungs of the representative examples of the male example and control group 500 mg / kg group abnormalities of the lung were observed at necropsy, Hematoxylin-Eosin staining after paraffin embedding according to a conventional method Samples were prepared and histopathologically examined.

- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology

2.Details on study design
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
General condition:
The general condition and the presence or absence of death were observed once a day until the administration day and 6 hours after administration (30 minutes after administration, 2, 4 and 6 hours after administration) before administration and during the observation period from the day after administration .

Weight measurement:
Measurement was made on the administration day (immediately before administration) and 1, 3, 7, 10 and 14 days after administration in the morning.

Autopsy:
The dead animals were necropsied promptly after discovery. At the end of the observation period, the surviving animals were sacrificed by exsanguination from the abdominal aorta under ether anesthesia and then necropsied, and findings were recorded. A control group of lung abnormalities is accepted lung and its comparison with autopsy, after taking a picture for a representative example, and fixed and stored in 10% neutral buffered formalin.

Histopathological examination:
Of the animals that survived for more than 24 hours after administration, the lungs of the representative examples of the male example and control group 500 mg / kg group abnormalities of the lung were observed at necropsy, Hematoxylin-Eosin staining after paraffin embedding according to a conventional method Samples were prepared and histopathologically examined.

- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology


3.No data available

Statistics:

1. and 2.

(1)LD 50 value:
The LD50 value and its 95% confidence limit value were calculated by the Behrens- Ker method.

(2) Body weight:
For each group, the average value and the standard deviation were calculated. Significant difference test was carried out using a multiple
comparison test between the control group and the test substance administered each group, and a significant risk rate of less than 5%, less than 5% and (p <0.05) less than 1% and (p <0.01) Respectively.
That performs equal variances assay by Bartlett method, in the case of equal variance was dispersed analysis by one-way layout method, Dunnett
method between groups compared with the control group if significant (if the number of cases is equal to) or Scheff Method (when the number of cases are not equal). On the other hand, when the observed and equal variance was analyzed by one-way method using rank (Kruskal-Wallis tests),Dunnett method or Scheff between groups compared with the control group if significant using a ranking method .


3.No data available

Preliminary study:

1.As a result of preliminary test,groups of 300 and 200 mg / kg were set using distilled water as a medium. As a control, a group to administer the same liquid volume of each medium was provided.


2.As a result of preliminary test (administration stage: 20, 200 and 2000 mg / kg when using corn oil as a medium, 20 and 200 mg / kg when distilled water is used as a medium), 2000 mg / Three out of three died in the kg group, but no death occurred in any of the media in the group of 200 mg / kg or less. Therefore, the dose of this test was 2000 mg / kg as the highest dose using corn oil as a medium, and the group
was set to 1300, 800, 500, 300 and 200 mg / kg group by the common ratio of about 1.6. In addition, groups of 300 and 200 mg / kg were set using distilled water as a medium. As a control, a group to administer the same liquid volume of each medium was provided.



3.No data available

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 300 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no mortality was observed

Sex:

male/female

Dose descriptor:

LD50

Effect level:

526 mg/kg bw

Based on:

test mat.

Remarks on result:

other: 50% mortality was observed

Sex:

not specified

Dose descriptor:

LD50

Effect level:

500 mg/kg bw

Based on:

test mat.

Remarks on result:

other: 50% mortality was observed

Mortality:

1.No death occurred in the highest dose group in both males and females, and the LD50 value was 300 mg / kg or more

2.In death cases, dark reddening of the lung was observed in almost all cases. Pale yellow pleural effusion was found in one female in the 500 mg / kg
group, in the 800 mg / kg and 1300 mg / kg groups, in 3 to 5 cases in males and females, and in 1 case in the 2000 mg / kg group.
In the surviving cases, there was no remarkable change.


3.No data available

Clinical signs:

other: 1.No abnormal symptoms were observed in any of the control groups.In the 200 mg / kg group, a staggering walking, salivation, lacrimation and the like were observed from about 15 minutes after the administration,but in 2 hours after the administration, th

Gross pathology:

1.In the surviving cases, there was no remarkable change.

2.Very mild edema was observed in the male lungs of the 500 mg / kg group who died 2 days after administration.


3.No data available

Other findings:

2.No abnormal symptoms were observed in the control group.In the 200mg/kg group,contamination of the lower abdomen was observed on 1 day after administration in one female,but no abnormal symptoms were observed in any of the sexes after 2 days from the administration.In the 300 mg/kg group,salivation was observed in 3 males and 3 females approximately 30 minutes after administration,but disappeared 2 hrs after administration.On the 1st day after administration,dirt on the lower abdomen and brown urine were observed in all females,but no abnormal symptoms were observed in any of the males and females after 2 days from the administration.In the 500 mg/kg group,salivation(disappearance at 2 hrs after administration) was observed in one female about 25 min. after administration and spontaneous locomotor activity was observed about 4 hrs after administration(at 6 hrs after administration Has disappeared).1 female died 1 day after administration,and other cases showed a decrease in locomotor activity,cyanosis,brown urine,staining on the lower abdomen.Even in males,cyanosis,brown urine and the like were observed.1 animal with spontaneous locomotor reduction,ankylosing convulsions,cyanosis,brown urine at the time of observation on 1 day after administration died 2 days after administration.Brown urine continued from 2 to 3 days after administration and cyanosis lasted 5 days after administration,but no abnormal symptoms were observed in any of the cases after 6 days after administration.In the group of 800 mg/kg or more,rough walking,salivation,lacrimation,spontaneous locomotor reduction, etc. were observed from about 5 to 30 min. after administration,but after about 2 hrs from the administration,it was abdomen,epidermal decline,respiratory depression,cyanosis,Symptoms such as tingling were seen.Approximately 6 hrs after administration,one each sex of the 2000 mg/kg group died. All other cases died one day after administration.

3.No data available

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

The test chemical 4-Methoxybenzylamine (2393-23-9) is likely to be toxic in the dose range of >300-526 mg/kg bw.

Executive summary:

Data available for the structurally similar read across chemicals has been reviewed to determine the acute oral toxicity of the test chemical 4-Methoxybenzylamine (2393-23-9).The studies are as mentioned below:

1.Acute oral toxicity study was performed in male and female Sprague Dawley rats[Crj: CD (SD) ]

using test material test chemical.Distilled water was used as vehicle.Preliminary test was also done.No mortality was observed at dose 300 mg/kg bw.Animals were examined for clinical signs,histopathology, changes in body weight and organ weights.In clinical signs observation,No abnormal symptoms were observed in any of the control groups.In the 200 mg / kg group, a staggering walking, salivation, lacrimation and the like were observed from about 15 minutes after the administration, but in 2 hours after the administration, there was only a decrease in locomotor activity in one males, and other symptoms It disappeared. On the first day after the administration, contamination of the lower abdomen was observed in 2 females, but no abnormal symptoms were observed in any of the males and females after 2 days from the administration.In the 300 mg / kg group, immediately after administration, prone and breathing slowed, salivation from about 5 to 20 minutes after the administration, staggering walking and the like were observed, but disappeared at 2 hours after administration. Spontaneous exercise reduction and epidermal decline were observed after 2 hours from the administration, and the locomotor activity reduction continued even 6 hours after the administration. On the first day after administration, females showed dirt on the lower abdomen and brown urine, but no abnormal symptoms were observed in any of the males and females after 2 days from the administration.In body weight examination,each group of male and female rats showed almost the same trend as the control group, and no significant difference was observed. In the surviving cases, there was no remarkable change in gross pathological examination.Hence, Thelethal concentration (LD50) valuefor acute oral toxicity testwas considered to be>300mg/kg bw,when male and female Sprague Dawley rats were treated with test chemical orally via gavage.Thelethal concentration (LD50) valuefor acute oral toxicity testwas considered to be>300mg/kg bw,when male and female Sprague Dawley rats [Crj: CD (SD)]were treated with test chemical orally via gavage.

2.Acute oral toxicity study was performed in male and female Sprague Dawley rats[Crj: CD (SD)]

using test material test chemical.Preliminary test was also done.Dead cases were observed in the group of 500 mg / kg or more when using corn oil as a medium. The death occurred about 6 hours after administration in one each sex of the 2000 mg / kg group. On the other hand, in other cases in the 2000 mg / kg group, sexes in the 1300 and 800 mg / kg group and 1 female in the 500 mg / kg group were one day after administration. Only one male in the 500 mg / kg group was dead on 2 days after administration.There was almost no weight gain on the first day after administration. In death cases, symptoms such as wiggle walking, salivation, rare lacrimation after death, then abdomen, epidermal warming,respiratory depression, cyanosis were observed. At autopsy, it was thought that the cause of death was due to circulatory disorder, as dark reddening of lung was observed in almost all cases. At necropsy, there were many cases of pleural effusion in 800 and 1300 mg / kg group, but in 2000 mg /kg group it was less, but the death time in 2000 mg / kg group was lower than that in other group.Hence,LD50 value was considered to be 526 mg/kg bw(95% confidence limit:385 - 686),when

male and female Sprague Dawley rats[Crj: CD (SD)] were treated with test chemical orally via gavage.

3.Acute oral toxicity study was performed in mouse using test material test chemical.50% mortality was observed at dose 500 mg/kg bw. Hence,LD50 value was considered to be 500 mg/kg bw,when mouse were treated with test chemical orally.

Thus, based on the above summarised studies,4-Methoxybenzylamine (2393-23-9) and it’s structurally similar read across substance, it can be concluded that LD50 value is between 300-2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation,4-Methoxybenzylamine (2393-23-9) can be classified as “Category IV” for acute oral toxicity.Hence,based on the data available for the structurally similar read across, test chemical 4-Methoxybenzylamine (2393-23-9)is likely to be toxic in the dose range of >300-526 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

526 mg/kg bw

Quality of whole database:

Data is Klimisch 2 and from authoritative database

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

other justification

Justification for data waiving:

other:

Endpoint conclusion

Quality of whole database:

Waiver

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Data waiving:

other justification

Justification for data waiving:

the study does not need to be conducted because the substance is classified as corrosive to the skin

Endpoint conclusion

Quality of whole database:

Waiver

Additional information

Acute oral toxicity:

Data available for the structurally similar read across chemicals has been reviewed to determine the acute oral toxicity of the test chemical 4-Methoxybenzylamine (2393-23-9).The studies are as mentioned below:

1.Acute oral toxicity study was performed in male and female Sprague Dawley rats[Crj: CD (SD) ]

using test material test chemical.Distilled water was used as vehicle.Preliminary test was also done.No mortality was observed at dose 300 mg/kg bw.Animals were examined for clinical signs,histopathology, changes in body weight and organ weights.In clinical signs observation,No abnormal symptoms were observed in any of the control groups.In the 200 mg / kg group, a staggering walking, salivation, lacrimation and the like were observed from about 15 minutes after the administration, but in 2 hours after the administration, there was only a decrease in locomotor activity in one males, and other symptoms It disappeared. On the first day after the administration, contamination of the lower abdomen was observed in 2 females, but no abnormal symptoms were observed in any of the males and females after 2 days from the administration.In the 300 mg / kg group, immediately after administration, prone and breathing slowed, salivation from about 5 to 20 minutes after the administration, staggering walking and the like were observed, but disappeared at 2 hours after administration. Spontaneous exercise reduction and epidermal decline were observed after 2 hours from the administration, and the locomotor activity reduction continued even 6 hours after the administration. On the first day after administration, females showed dirt on the lower abdomen and brown urine, but no abnormal symptoms were observed in any of the males and females after 2 days from the administration.In body weight examination,each group of male and female rats showed almost the same trend as the control group, and no significant difference was observed. In the surviving cases, there was no remarkable change in gross pathological examination.Hence, Thelethal concentration (LD50) valuefor acute oral toxicity testwas considered to be>300mg/kg bw,when male and female Sprague Dawley rats were treated with test material orally via gavage.Thelethal concentration (LD50) valuefor acute oral toxicity testwas considered to be>300mg/kg bw,when male and female Sprague Dawley rats [Crj: CD (SD)]were treated with test chemical orally via gavage.

2.Acute oral toxicity study was performed in male and female Sprague Dawley rats[Crj: CD (SD)]

using test material test chemical.Preliminary test was also done.Dead cases were observed in the group of 500 mg / kg or more when using corn oil as a medium. The death occurred about 6 hours after administration in one each sex of the 2000 mg / kg group. On the other hand, in other cases in the 2000 mg / kg group, sexes in the 1300 and 800 mg / kg group and 1 female in the 500 mg / kg group were one day after administration. Only one male in the 500 mg / kg group was dead on 2 days after administration.There was almost no weight gain on the first day after administration. In death cases, symptoms such as wiggle walking, salivation, rare lacrimation after death, then abdomen, epidermal warming,respiratory depression, cyanosis were observed. At autopsy, it was thought that the cause of death was due to circulatory disorder, as dark reddening of lung was observed in almost all cases. At necropsy, there were many cases of pleural effusion in 800 and 1300 mg / kg group, but in 2000 mg /kg group it was less, but the death time in 2000 mg / kg group was lower than that in other group.Hence,LD50 value was considered to be 526 mg/kg bw(95% confidence limit:385 - 686),when

male and female Sprague Dawley rats[Crj: CD (SD)] were treated with test chemical orally via gavage.

3.Acute oral toxicity study was performed in mouse using test material test chemical.50% mortality was observed at dose 500 mg/kg bw. Hence,LD50 value was considered to be 500 mg/kg bw,when mouse were treated with test chemical orally.

Thus, based on the above summarised studies,4-Methoxybenzylamine (2393-23-9) and it’s structurally similar read across substance, it can be concluded that LD50 value is between 300-2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation,4-Methoxybenzylamine (2393-23-9) can be classified as “Category IV” for acute oral toxicity.Hence,based on the data available for the structurally similar read across, test chemical 4-Methoxybenzylamine (2393-23-9)is likely to be toxic in the dose range of >300-526 mg/kg bw.

Acute inhalation toxicity:

(4-methoxyphenyl)methanamine has very low vapor pressure of 0.2 mm Hg at 50?C, so the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore this end point for acute inhalation toxicity by inhalation route is considered for waiver.

Acute dermal toxicity:

The substance 4-methoxyphenyl)methanamine is considered to be corrosive to skin. No acute dermal toxicity studies for the target chemical are available based on the corrosive nature of the test chemical. Based on these considerations, the end point for acute dermal toxicity is considered as waiver.

Justification for classification or non-classification

Based on the above experimental studies on 4-Methoxybenzylamine (2393-23-9) and it’s structurally similar read across substances, it can be concluded that LD50 value is between 300-2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation,4-Methoxybenzylamine (2393-23-9) can be classified as “Category IV” for acute oral toxicity. For Acute dermal and inhalation toxicity wavier was added so, not possible to classify.