Morpholinium, 4-[2-[2-[(2-hydroxyphenyl)methylene]hydrazinyl]-2-oxoethyl]-4-methyl-, chloride (1:1)

Endpoint summary

Description of key information

LD50 oral ca. 2000 mg/kg bw (BASF SE, 2011)
LD50 dermal > 2000 mg/kg bw (Bioassay, 2013)

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Additional information

Acute oral toxicity:

In an acute oral toxicity study performed according to the Acute Toxic Class method (OECD 423 guideline and GLP), doses of 2000 and 300 mg/kg bw of the test item Tinocat ES 96000 (preparations in doubly deionized water) were administered to four test groups of three fasted Wistar rats each (2000 mg/kg bw in 6 females, 300 mg/kg bw in 6 females) by gavage in a sequential manner. No death occured at 300 mg/kg bw, 3/6 animals died at 2000 mg/kg bw. The LD50 therefore was ca. 2000 mg/kg bw.

Acute dermal toxicity:

In a GLP-compliant acute dermal toxicity study (Limit Test) performed according to OECD guideline 402, young adult Wistar rats (5 males and 5 females) were dermally exposed to a single dose of 2000 mg/kg bw ofTinocat ES 96000(as suspension in deionized water) to the clipped skin (dorsal and dorso-lateral parts of the trunk) and covered by semi-occlusive dressing for 24 hours (Bioassay, 2013). The application area comprised at least 10% of the total body surface area. The animalswere observed for 14 days. Delayed mortality occurred in one male animal on day 6. The mortality was most likely incidental and not substance-related. No signs of systemic toxicity were observed.In the male test group very slight erythema (grade 1) was noted in one animal from study day 1 up to study day 3. Moderate to severe erythema (grade 3 to 4) and very slight edema (grade 1) was noted in 4 male animals at study day 1. Thereafter in three of the four animals welldefined erythema (grade 2) was observed at study day 2 and very slight erythema (grade 1) was observed at study day 3. In 1 male animal very slight erythema (grade 1) was observed at study day 2. In addition one male animal showed incrustations at study day 3. Very slight erythema (grade 1) was noted in all female animals at study day 1. In three female animals very slight erythema (grade 1) persisted until study day 2.

The mean body weight of the animals increased within the normal range throughout the study period. The following macroscopic pathologic findings were observed in the male animal that died: swollen kidneys and ascites with erythroid liquid. No macroscopic pathologic abnormalities were noted in the other animals (4 males and 5 females) examined on the last day of observation. Accordingly, the acute dermal median lethal dose (LD50) was determined to beLD50, dermal, rat > 2000 mg/kg bw.

Justification for classification or non-classification

The oral LD50 is ca. 2000 mg/kg bw for male and female rats. Therefore classification according to EU (67/548/EEC) - and CLP (1272/2008/EC) requirements is neccessary for this endpoint (EU: R22/ CLP: Cat. 4 acute oral). As the dermal LD50 is > 2000 mg/kg, no classification according to EU (67/548/EEC) - and CLP (1272/2008/EC) is required for acure dermal toxicity.