Reaction product of Aminoguanidine bicarbonate and Tall Oil fatty acid

Endpoint summary

Description of key information

One oral and two dermal studies were performed to examine the acute toxicity of H7134. According to the results the test material is not acutely toxic after either oral ingestion or contact with the skin.

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

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Additional information

One acute oral study and two acute dermal studies are available with HiTEC 7134, which fully satisfy the requirements of REACH Regulation for this endpoint. An inhalation study was not performed taking into consideration the very low vapour pressure of the substance, as well as its very high viscosity.

In the oral assessment (Johnson IR (2011a)), a group of five male and five female Alpk: APfSD (Wistar derived) rats received a single oral dose of 2000 mg HiTEC 7134/kg bw and were observed daily for the following 14 days for any signs of toxicity. There were no signs of evident toxicity, and most of the animals showed an overall weight gain during the study. No compound-related abnormalities were detected at post mortem examination. The highest fixed dose of H7134 administered in this test did not cause any lethality, and thus, the oral LD50 is higher than 2000 mg/kg bw.

In one of the dermal toxicity assessments, which was considered to be the key study, five male and five female Alpk: AP_fSD rats were dermally exposed to 2000 mg/kg bw of HiTEC 7134 for 24h (Johnson IR (2001b)). The study was performed according to the OECD Guideline 402. No signs of toxicity were detected, besides slight skin irritation, which totally resolved by the end of the study. No mortality was seen, and hence, the dermal LD50 is higher than 2000 mg H7134/kg bw.

In the second acute dermal toxicity study, one group of ten New Zealand White rabbits (five males and five females) was used. One dermal semi-occluded patch of HiTEC 7134 at 2000 mg/kg, was applied to the clipped dorsal skin of each animal (Mallory VT (1995)). The patches were removed after 24 hours, and the animals were observed for 14 days. No signs of toxicity were detected, besides skin irritation (erythema, edema, fissuring and sloughing) at the application site. None of the animals died during the study; the estimated acute dermal LD50 was determined to be greater than 2000 mg/kg bw.

Justification for selection of acute toxicity – inhalation endpoint
There is no available acute toxicity study using the inhalation route. Due to the physical-chemical properties of the substance, generation of vapors or aerosols is unfeasible; thus, no inhalation studies (acute or repeated-dose) were performed. The log Kow is above 6.4, indicating that the substance is highly lipophilic and viscous, and the vapor pressure is very low, 0.00002 Pa. The test substance is clearly not volatile.

Justification for classification or non-classification

Both oral and dermal LD50s are higher than 2000 mg/kg bw, on the basis of the aforementioned results. HiTEC 7134 did not exert any toxic effects in all three studies, besides skin irritation in the dermal studies. It shall not be classified as acutely toxic after oral ingestion or skin contact, according to the criteria laid down in Regulation (EC) 1272/2008.