p-anisylamine

Endpoint summary

Description of key information

Repeated dose toxicity: Oral

Repeated dose oral toxicity was predicted for 4-Methoxybenzylamine using data from structurally and functionally similar read across chemicals. The studies are as mentioned below:

Chronic toxicity oral study for the 70 -80% structurally and functionally similar test compound was studied in male and female Osborne-Mendel rats. The test compound was fed through the diet at a concentration of 0 or 1000 ppm (0 or 50 mg/Kg bw) for 15 weeks. The animals were observed weekly for weight, food intake and general condition. Haematological examinations were made at termination. These examinations included white cell counts, red cell counts, haemoglobins and haematocrits. No effects were noted in the treated animals at the mentioned dose level. Based on the observations made, the no observed Adverse Effect Level (NOAEL) for the test compound in Osborne-Mendel rats is found to be 50 mg/Kg bw.

Combined repeated dose- carcinogenicity study was also conducted for 60 -70% structurally and functionally similar read across chemical using male and female mice of strain B6C3F1 for 18 months. The chemical was used at dose levels of 0 or 215 mg/Kg and given daily for 18 months. Oral administration by stomach tube was initiated from 7th day of age to 28th weanling day following which the compound was mixed with the ground feed. Animals were observed daily for any abnormalities and palpated weekly at time of weighing for enlargement of liver and spleen. Animals which appeared moribund were killed for necropsy. One mice of each sex died during the 18 months experimental study period. Significant weight gain was observed with the increase in duration from 4, 26, 52 weeks to 18 months. Incidence of Type A Reticulum cell carcinoma and Hepatic carcinoma with kidney metastasis was observed in 1 male animal each and Pulmonary adenoma was noted in 2 female mice. Based on the observations made, No Observed Adverse Effect Level (NOAEL) for the test chemical is considered to be <215 mg/Kg.

Based on the data summarized for the structurally and functionally similar read across chemicals, 4-Methoxybenzylamine is not likely to be toxic as per the criteria mentioned in CLP regulation.

Repeated dose toxcity: Inhalation

(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 repeated dose toxicity by inhalation route is considered for waiver.

Repeated dose toxicity: Dermal

The substance 4-methoxyphenyl)methanamine is considered to be corrosive to skin. No repeated dose 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 repeated dermal toxicity is considered as waiver.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

NOAEL

Quality of whole database:

Data is from K2 prediction database

Repeated dose toxicity: inhalation - systemic effects

Link to relevant study records

Reference

Endpoint:

repeated dose toxicity: inhalation, other

Data waiving:

other justification

Justification for data waiving:

other:

Endpoint conclusion

Quality of whole database:

Waiver

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion

Quality of whole database:

Waiver

Repeated dose toxicity: dermal - local effects

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Repeated dose toxicity: Oral

Repeated dose oral toxicity was predicted for 4-Methoxybenzylamine using data from structurally and functionally similar read across chemicals. The studies are as mentioned below:

Chronic toxicity oral study for the 70 -80% structurally and functionally similar test compound was studied in male and female Osborne-Mendel rats. The test compound was fed through the diet at a concentration of 0 or 1000 ppm (0 or 50 mg/Kg bw) for 15 weeks. The animals were observed weekly for weight, food intake and general condition. Haematological examinations were made at termination. These examinations included white cell counts, red cell counts, haemoglobins and haematocrits. No effects were noted in the treated animals at the mentioned dose level. Based on the observations made, the no observed Adverse Effect Level (NOAEL) for the test compound in Osborne-Mendel rats is found to be 50 mg/Kg bw.

Combined repeated dose- carcinogenicity study was also conducted for 60 -70% structurally and functionally similar read across chemical using male and female mice of strain B6C3F1 for 18 months. The chemical was used at dose levels of 0 or 215 mg/Kg and given daily for 18 months. Oral administration by stomach tube was initiated from 7th day of age to 28th weanling day following which the compound was mixed with the ground feed. Animals were observed daily for any abnormalities and palpated weekly at time of weighing for enlargement of liver and spleen. Animals which appeared moribund were killed for necropsy. One mice of each sex died during the 18 months experimental study period. Significant weight gain was observed with the increase in duration from 4, 26, 52 weeks to 18 months. Incidence of Type A Reticulum cell carcinoma and Hepatic carcinoma with kidney metastasis was observed in 1 male animal each and Pulmonary adenoma was noted in 2 female mice. Based on the observations made, No Observed Adverse Effect Level (NOAEL) for the test chemical is considered to be <215 mg/Kg.

Based on the data summarized for the structurally and functionally similar read across chemicals, 4-Methoxybenzylamine is not likely to be toxic as per the criteria mentioned in CLP regulation.

Repeated dose toxcity: Inhalation

(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 repeated dose toxicity by inhalation route is considered for waiver.

Repeated dose toxicity: Dermal

The substance 4-methoxyphenyl)methanamine is considered to be corrosive to skin. No repeated dose 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 repeated dermal toxicity is considered as waiver.

Based on the data available for thetarget chemical and its read across, (4-methoxyphenyl)methanamine (CAS no 2393 -23 -9) is not likely to be toxic upon repeated exposure by oral route as per the criteria mentioned in CLP regulation.

Justification for classification or non-classification

Based on the data available for thetarget chemical and its read across, (4-methoxyphenyl)methanamine (CAS no 2393 -23 -9) is not likely to be toxic upon repeated exposure by oral route as per the criteria mentioned in CLP regulation.