Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Additional information

No reproductive toxicity study is available. However, in a 90-day repeated toxicity study conducted with alpha-pinene, no effects were observed on reproductive organs (tissues examined microscopically: epididymidis, preputial gland, prostate, seminal vesicle and testes for males, clitoral gland, ovary and uterus for females). Moreover, in a GLP teratogenicity study conducted according to OECD guideline 414 with camphene and in a teratogenicity/postnatal development study using rowachol (terpene mixture of alpha/beta pinene (17%)), no teratogenic effects and no postnatal development effects (on pups observed for 4 weeks after birth) were identified. Thus, no reproductive toxicity is expected based on the results of these studies and a reproductive toxicity study is not deemed necessary.


Short description of key information:
No reproductive toxicity study is available. However, in a 90-day repeated toxicity study conducted with alpha-pinene, no effects were observed on reproductive organs (tissues examined microscopically: epididymidis, preputial gland, prostate, seminal vesicle and testes for males, clitoral gland, ovary and uterus for females). Moreover, in a GLP teratogenicity study conducted according to OECD guideline 414 with camphene and in a teratogenicity/postnatal development study using rowachol (terpene mixture of alpha/beta pinene (17%)), no teratogenic effects and no postnatal development effects (on pups observed for 4 weeks after birth) were identified.

Effects on developmental toxicity

Description of key information
In a GLP teratogenicity study conducted according to OECD guideline 414 with camphene and in a teratogenicity/postnatal development study using rowachol (terpene mixture of alpha/beta pinene (17%)), no teratogenic effects and no postnatal development effects (on pups observed for 4 weeks after birth) were identified.
Effect on developmental toxicity: via oral route
Dose descriptor:
NOAEL
250 mg/kg bw/day
Additional information
In a GLP teratogenicity study conducted according to OECD guideline 414 with camphene and in a teratogenicity/postnatal development study using rowachol (terpene mixture of alpha/beta pinene (17%)), no teratogenic effects and no postnatal development effects (on pups observed for 4 weeks after birth) were identified. A NOAEL for maternal toxicity was set at 250 mg/kg bw/day based on clinical signs (reduced motor activity and salivation) and transient impairment of food consumption observed at 1000 mg/kg bw/day. A NOAEL for developmental toxicity was set at 250 mg/kg bw/day based on the slight increase (statistically non-significant at p≤0.01) number of resorptions and consequently the post-implantation loss at 1000 mg/kg bw/day.

For further information on read-across justification, see section 13: point "read-across approach".

Justification for classification or non-classification

No reproductive toxicity study is available. However, in a 90-day repeated toxicity study conducted with alpha pinene, no effects were observed on reproductive organs (tissues examined microscopically: epididymidis, preputial gland, prostate, seminal vesicle and testes for males, clitoral gland, ovary and uterus for females). Moreover, in a GLP teratogenicity study conducted according to OECD guideline 414 with camphene and in a teratogenicity/postnatal development study using rowachol (terpene mixture of alpha/beta pinene (17%)), no teratogenic effects and no postnatal development effects (on pups observed for 4 weeks after birth) were identified. Thus, no reproductive toxicity is expected based on the results of these studies and (-)-beta pinene is not deemed to be classified for reproductive toxicity.

In a GLP teratogenicity study conducted according to OECD guideline 414 with camphene and in a teratogenicity/postnatal development study using rowachol (terpene mixture of alpha/beta pinene (17%)), no teratogenic effects and no postnatal development effects (on pups observed for 4 weeks after birth) were identified. Therefore, (-)-beta pinene is not classified according to Directive 67/548/CEE and CLP Regulation (EC) No 1272/2008.