9-Octadecenoic acid (Z)-, zinc salt, basic

Endpoint summary

Description of key information

In a study similar to US EPA OPP 81 -1 the test chemical was subjected to oral toxicity testing in rats of both sexes by oral gavage dosing at 5000mg/kg bw.
OECD Guideline 402 and EU Method B.3 (Acute Toxicity (Dermal)) A group of Wistar (RccHanTM:WIST) rats (5/sex/dose) were given a single dermal application of test item at 2000 mg/kg bw. 

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

GLP study Klimisch 1.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

GLP study Klimisch 1.

Additional information

Oral

In a study similar to US EPA OPP 81 -1 the test chemical was subjected to oral toxicity testing in rats of both sexes by oral gavage dosing. All animals appeared normal throughout the 14 -day observation period. No gross abnormalities were observed for the animals necropised at the conclusion of the study. The LD50 for this study is >5000 mg/kg. The test material is not classified in accordance with Regulation (EC) No. 1272/2008 based on studies in rats.

Inhalation

According to REACH Annex VIII Section 8.5 information on acute toxicity will be provided for at least one other route in addition to the oral route. The choice for the second route will depend on the nature of the substance and the likely route of human exposure. The substance is a waxy solid with a vapour pressure of 0.001 Pa at 25°C. Based on evaluation of the life cycle of the substance it is concluded that inhalation exposure will be low and that the most likely route of exposure for workers and consumers is the dermal route. Testing for acute toxicity via the inhalation route is, therefore, not required.

Dermal

OECD Guideline 402 and EU Method B.3 (Acute Toxicity (Dermal)) A group of Wistar (RccHan^TM:WIST) rats (5/sex/dose) were given a single dermal application of test item at 2000 mg/kg bw. The test item was moistened with Arachis oil BP and placed directly on back and flanks of the skin representing approximately 10 % of the total body surface of the animals. The test site was then covered by a semi-occlusive dressing for 24 h. Animals were then observed for mortality, clinical signs and bodyweights for 14 days.

No mortality and no clinical signs were observed during the study. There were no signs of dermal irritation. One female showed no gain in body weight during the first week with expected gain in body weight during the second week. One other female showed an expected gain in body weight during the first week but weight loss during the second week. The remaining animals showed expected gains in body weight over the study period. Patchy pallor of the liver, which may have been due to the time interval between termination and necropsy and not test item related, was noted at necropsy of all animals. Hydronephrosis and a cavity in the right kidney, both considered to be a genetic defect and not test item related, were also noted at necropsy of one female. The combined dermal LD50 was considered to be higher than 2000 mg/kg bw in rats. Under the test conditions, the acute dermal LD50 is higher than 2000 mg/kg bw in rats therefore the test item is not classified according to CLP Regulation (EC) No. 1272/2008.

Justification for selection of acute toxicity – oral endpoint
Key study

Justification for selection of acute toxicity – dermal endpoint
Key study

Justification for classification or non-classification

The test material does not meet EU CLP (Regulation (EC) No. 1272/2008) criteria for classification as acutely toxic via the oral or dermal routes based on studies involving rats.