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Diss Factsheets

Administrative data

Description of key information

Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test (according to OECD TG 422 and GLP) (BASF 96R0466/09052): 
NOAEL males = 4000 ppm (approx 270 mg nerolidol/kg bw/d )
NOAEL females = 1500 ppm (approx 105, 120 or 193 mg nerolidol/kg bw/d)

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
100 mg/kg bw/day
Study duration:

Additional information

In the key study, i.e. a Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test according to OECD TG 422 and GLP, nerolidol was administered via the diet to Wistar rats at 0, 1500, 4000, 12000 ppm for 37 days (males) and 58 days (females), (BASF 96R0466/09052). General systemic toxicity was noted in males at 12000 ppm and in females at 12000 and 4000 ppm. Salient findings were distinct decreases in food consumption and body weights/ body weight gain, which were most severe in females during gestation and lactation. Clinical pathological findings, i.e. increased GGT values (both sexes), reduced prothrombin time in females, decreased glucose levels in males or increased calcium levels in females were observed in the 12000 ppm dose group. Pathology revealed the liver to be the target organ of toxicity, showing increased weights in both sexes, starting from 4000 ppm in females, and at 12000 ppm in males. Accordingly, histopathological findings related to treatment were central hepatocellular hypertrophy and central fatty change in females at 12000 ppm. Further information on reproductive and developmental toxicity parameters are given in the chapter "Toxicity to reproduction".

Taken together, the NOAEL for males has been set to 4000 ppm (corresponding to about 270 mg/kg bw/d.) and the NOAEL for females has been set to 1500 ppm (corresponding to about 105, 120 or 193 mg/kg bw/d in non-pregnant, pregnant or lactating females, respectively) on the basis the reduced food consumption and body weights, clinical pathological changes and adverse liver changes.

Justification for classification or non-classification

The present data on repeated dose toxicity do not fulfill the criteria laid down in 67/548/EEC and 1272/2008/EEC, and therefore, a non-classification is warranted.