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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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.

Additional information