4-amino-m-cresol

Endpoint summary

Description of key information

Eye irritation :

According to the results of the key studies (one in vivo eye irritation study, two in vitro eye irritation studies), the registered substance 4-amino-m-Cresol did not induce irritation of corrosion of mucus membrane or eye after contact. Hence, it can be defined as Not classififed/Not irritating according to CLP regulation.

Skin irritation:

According to the results of the key studies (GLP compliant, Klimisch 1, OECD guideline method 439 and 431), the registered subtance 4 -amino-m-cresol did not induce skin irritation or corrosion on reconstructed human epidermis and was Not classiffied for Irritation and Corrosion.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Additional information

To assess the potential eye irritation or corrosion properties of the registered substance 4-amino-m-cresol, three key studies were available :

- One in vivo study (GLP-compliant, followed OECD 405 method, Klimisch 1) was performed. Female Pirbright White guinea pigs were used in the study. 0.1 ml of a 1.5 % dilution of 4-Amino-m-cresol in 50 % propylene glycol was applied into the conjunctival sac of the left eye of 5 female guinea pigs; the right eye served as control. The eyes were not rinsed and were evaluated and scored according to the Draize scoring system 0.5, 1, 2, 3, 4, 6, and 7 h after application. Further readings by means of fluorescein-instillation took place 24 h and 48 h after substance application. No ocular irritant effects were noted at any observation time point after 4-Amino-m-cresol as a 1.5 % dilution in 50 % propylene glycol was instilled into the eyes of guinea pigs without rinsing in 4 of the 5 tested animals. Conjunctival erythema was seen in one animal without any other macroscopic effect. 4-Amino-m-cresol at 1.5 % may have minimal ocular irritant potential.

- Two in vitro studies as Isolated Chicken Eye were performed, the two tests were GLP-compliant, followed OECD 438 method. The first is a Klimisch 2 due to absence of positive control in the test, the test item was used diluted at 1.5% in PEG. The second ICE test was quoted as Klimisch 1 and used pure test item. The most relevant of this two studies is the second according to REACh requirements :

4-Amino-M-Cresol (A074) was evaluated neat. A Skin irritation test using EpiSkinTM Reconstructed Human Epidermis model was performed (GLP compliant, OECD 439 method, Klimisch 1). Triplicate tissues were treated with the test item for an exposure period of 15 minutes. At the end of the exposure period each tissue was rinsed before incubating for 42 hours. At the end of the post-exposure incubation period each tissue was taken for MTT-loading. The relative mean viability of the test item treated tissues was 63.3% after the 15-Minute exposure period and 42-Hours post-exposure incubation period.

On in vitro studies was available to assess the potential skin corrosion of the test item :

- A Skin Corrosion potential test using EpiSkinTM Reconstructed Human Epidermis model was performed (GLP compliant, OECD 431 method, Klimisch 1). Duplicate tissues were treated with the test item for exposure periods of 3 and 60 minutes. Negative and positive control groups were treated for each exposure period. At the end of the exposure period the test item was rinsed from each tissue before each tissue was taken for MTT-loading. The optical density (OD) was measured at 562 nm. Under experimental conditions of the study, the registered substance did not induce decrease of the viability, 90.1% of viability after 3 minutes exposure and 80.8% of viability after 60 minutes exposure.

Justification for classification or non-classification

Eye irritation :

According to the results of the key studies (one in vivo eye irritation study, two in vitro eye irritation studies), the registered substance 4-amino-m-Cresol did not induce irritation of corrosion of mucus membrane or eye after contact. Hence, it can be defined as Not classififed/Not irritating according to CLP regulation. Non of the study with diluted substance showed irritation potential of the registered substance. Furthermore, the second in vitro key study showed no irritancy too with pure substance.

Skin Irritation/Corrsion

According to the results of the key studies (GLP compliant, Klimisch 1, OECD guideline method 439 and 431), the registered subtance 4 -amino-m-cresol did not induce skin irritation or corrosion on reconstructed human epidermis and was Not classiffied for Irritation and Corrosion.