Reaction mass of N, N'-hexane-1,6-diylbis [12-hydroxyoctadecanamide] and 12-hydroxy-N-[6-[1-oxoalkyl)amino] hexyl ] octadecanamide

Endpoint summary

Description of key information

The acute oral, dermal and inhalation toxicity of AD-1000 were determined, according to current guidelines, to be >2000 mg/kg bw, >2000 mg/kg bw and >5.2 mg/l, respectively.

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 inhalation route

Endpoint conclusion

Dose descriptor:

LC50

Value:

5 000 mg/m³

Acute toxicity: via dermal route

Endpoint conclusion

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Additional information

Oral toxicity

In a study performed according to OECD 423, EC B.1 tris, EPA and JMAFF guidelines, AD-1000 was administered by oral gavage to rats at 2000 mg/kg bw. The observation period was 14 days. No mortality and clinical signs occurred. The body weight gain shown by the animals over the study period was considered to be normal, and no macroscopic abnormalities were found. Therefore, the LD50 was determined to be >2000 mg/kg bw. According to the OECD 423 test guideline the LD50 cut off value was considered to exceed the 5000 mg/kg bw.

Dermal toxicity

In a study performed according to OECD 402, EC B.3, EPA and JMAFF guidelines, AD-1000 was administered by a single dermal application (occlusive) to rats at 2000 mg/kg bw for 24 hours. The observation period was 14 days. No mortality occurred. Hunched posture was observed in one male, and chromodacryorrhoea in one male and one female. These animals had recovered from the symptoms between days 2 and 3. The body weight gain shown by the animals over the study period was considered to be normal, and no macroscopic abnormalities were found. Erythema, scales and scabs were seen in the treated skin-area of 5/10 animals during the observation period. Therefore, the LD50 was determined to be >2000 mg/kg bw.

Inhalation toxicity

In a study performed according to OECD 403, EC B.2, EPA and JMAFF guidelines, AD-1000 was administered by inhalation for 4 hours to rats (5/sexe), nose only. The observation period was 14 days. The mean actual concentration was 5.2 +/- 0.4 mg/l, the nominal concentration was 14.6 mg/l with a generation efficiency (ratio of actual and nominal concentration) of 35.6%. The mean mass aerodynamic diameter (MMAD) was determined twice, being 1.8 microm. on both occasions. One female was found dead 3 hours post-treatment, no further mortality occurred. No clinical signs were noted during exposure. After exposure, hunched posture, piloerection, ptosis and slow breathing were noted among the majority of the animals. Laboured respiration was noted among the majority of the males and rales were noted in one female. The surviving animals had recovered from the symptoms between days 2 and 3. The body weight gain shown by the surviving animals over the study period was considered to be normal and no macroscopic abnormalities were found. Macroscopic post mortem examination of the animal that died during the study showed granular, gray-white contents in the trachea, gray-white discolouration of the tongue and many, dark red foci on the lungs. Therefore, the LC50 was determined to be >5 mg/l.

Justification for classification or non-classification

Based on the studies present, AD-1000 does not have to be classified according to 67/548/EEC and the CLP Regulation (EC) No 1272/2008 for acute oral, dermal or inhalation toxicity.