Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
1.004 µg/L
Assessment factor:
500
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
5.02

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.1 µg/L
Assessment factor:
5 000
Extrapolation method:
assessment factor

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
3.26 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
0.337 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.034 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
0.067 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
13.1 mg/kg food
Assessment factor:
90

Additional information

PNEC Water (freshwater, marine water, intermittent)

The proposed approach to derive PNEC values is the assessment factor method where a toxicity value is divided by an assessment factor. The size of the assessment factor accounts for a number of uncertainties:

-intra- and inter-laboratory variation of toxicity data

-intra- and inter-species variations (biological variance)

-short-term to long-term toxicity extrapolation

-laboratory data to field impact extrapolation.

When acute data are available for three trophic levels, the standard approach to PNEC determination is to apply an assessment factor of 1000 to the lowest lethal or effect concentration (E(L)C50). However, the assessment factor presented in Table R.10 -4 from ECHA Guidance R.10 should be considered as general factors that under certain circumstances may be changed according to justification including one or more of the following:

-evidence from structurally similar compounds (evidence established by read across from closely related compounds may demonstrate that a higher or lower factor may be appropriate);

-knowledge of the mode of action including endocrine disrupting effects (some substances, by virtue of their structure, may be known to act in a non-specific manner);

-the availability of test data from a wide selection of species covering additional taxonomic groups other than those represented by the base-set species;

-the availability of test data from a variety of species covering the taxonomic groups of the base-set species across at least three trophic levels.

In such a case the assessment factors may only be lowered if these multiple data points are available for the most sensitive taxonomic group.

The assessment factor used for determination of the PNEC water is based on the following rationale.

Measured acute data

Reliable short-term toxicity data are provided for (-)-beta-pinene covering three trophic levels (fish, invertebrates, algae). The relevant values are: Fish:

96h-LC50= 0.502 mg/L (Pimephales promelas, measured concentrations)

96h-LC50= 0.557 mg/L (Cyprinus carpio, measured concentrations)

Daphnia magna:

48h-EC50= 1.250 mg/L (measured concentrations)

48h-EC50= 1.248 mg/L (measured concentrations)

Algae:

48h-EC50 = 0.826 mg/L (Pseudokirchneriella subcapitata, measured concentrations)

The ratio between the lowest acute and the highest acute is 2.7, suggesting a low inter-species variation for aquatic toxicity.

Mode of action

(-)-beta-Pinene is a bicyclic monoterpene and is structurally similar to alpha-pinene, delta-3-carene. These substances exhibit aquatic toxicity data in the same range as (-)-beta-pinene. According to toxtree v.2.5.1, when applying Verhaar et al. (1992) schedule or Enoch et al. (2008) modifying Verhaar's schedule, alpha-pinene, delta-3-carene, and (-)-beta-pinene have all a narcotic MoA, Mode of Action 1, which is considered to be the baseline toxicity MoA, the least toxic MoA.

Predicted acute data

Fish: 96h-LC50= 0.68 mg/L

Daphnia: 48h-EC50= 1.09 mg/L

Algae: 72h-EC50= 0.70 mg/L

The predictions are obtained with QSAR for the Mode of Action 1, based on validated data derived from standard toxicity test, for which the concentrations of the test item had been determined by chemical analyses over the test period. The predictions are sufficiently robust, and are appropriate for the purposes of chemical safety assessment required for REACH.

Acute to Chronic ratios

It is generally assumed that for MoA 1 the Acute to Chronic Ratio (ACR) is below 100 and ranges from 5 to 10. In the case of substance (-)-beta-pinene, algae-NOEC is not available. Instead of a NOEC, an EC10 is available. Considering the EC50 (0.826 mg/L) and the EC10 (0.378 mg/L) from the algae study, ACR for (-)-beta-pinene is therefore 2.19. This is below the expected ACR for MoA 1. Therefore, even without any other chronic data, it is assumed that the interspecies uncertainty is lower than whether we had other MoA.

The standard AF of 1000 for the freshwater PNEC derivation enables to cover all types substances, the narcotic mode of action and the other modes considered more toxic. According to the MoA and the ACR value for algae, it is assumed that AF for determination of PNEC water can be lowered from 1000 to 500.

The selected value for PNEC freshwater is based on experimental short-term data of 0.502 mg/L.

PNEC freshwater (mg/L) value = 1E-03 (AF = 500)

PNEC marine water (mg/L) value = 0.1E-03 (AF = 5000, an additional assessment factor of 10 is applicable for extrapolation from freshwater to marine species)

PNEC aqua (intermittent releases) (mg/L) value = 1E-02 (AF = 50, the assessment factor for PNEC freshwater is reduced by a factor of 10, when releases are intermittent)

PNEC stp

One respiration inhibition test carried according to OECD Guideline No 209 is available. The 3h-EC50 was considered to be 326 mg/L. The 3h-EC10 was considered as 38 mg/L. The standard approach is to apply an assessment factor of 100 on the EC50 value.

PNEC STP value (mg/L) = 3.26 (AF = 100)

PNEC sediment

In the absence of ecotoxicological data, a provisional PNEC sediment (freshwater) is calculated using the equilibrium partitioning method.

The calculation is the following: PNEC sediment = (Ksusp-water*PNECaqua*1000)/RHOsusp

with: Ksusp-water = 83.8 m3/m3 (with a Koc of 3317 L/kg) and RHOsusp = 1150 kg/m3.

PNEC sediment (freshwater) value = 73.2 µg/kg wwt (337 µg/kg dwt)

PNEC sediment (marine water) value = 7.32 µg/kg wwt (33.7 µg/kg dwt)

PNEC soil

In the absence of ecotoxicological data, a provisional PNEC soil is calculated using the equilibrium partitioning method.

The calculation is the following: PNECsoil = (Ksoil-water*PNECaqua*1000)/RHOsoil

with: Ksoil-water = 100 m3/m3 (with a Koc of 3317 L/kg) and RHOsoil = 1700 kg/m3.

PNEC soil = 59.2 µg/kg wwt (67.1 µg/kg dwt)

Secondary poisoning

Two 90-day inhalation toxicity studies were conducted in rats and mice with alpha-pinene. The NOAEL was 82.14 mg/kg bw/d for an exposure of 6h/day and 5 days/week. Taking into account the exposure during a repeated oral study, the NOAEL can be estimated to 14.66 mg/kg bw/d (exposure during 24h; see the endpoint summary of the point 7). A NOAEL was determined to be 14.66 mg/kg bw/d. The NOAEC is converted from this NOAEL by using the conversion factor 8.3. The NOAEC is estimated to be 121.7 mg/kg food.

Conclusion on classification

The substance is an organic substance. It is slightly soluble in water (ca. 6.95 mg/L according to standard methods) and stable to hydrolysis.

The following toxicity values are available for the substance:

Fish Acute:

Pimephales promelas: 96h-LC50 = 0.502 mg/L (measured concentrations)

Cyprinus carpio: 96h-LC50 = 0.557 mg/L (measured concentrations)

QSAR estimation based on Mode of Action 1: 96h-LC50= 0.68 mg/L

Aquatic invertebrates:

Daphnia magna: 48h-EC50 = 1.250 mg/L (measured concentrations)

Daphnia magna: 48h-EC50 = 1.345 mg/L (measured concentrations)

QSAR estimation based on Mode of Action 1: 48h-EC50= 0.86 mg/L

Geometric mean of the three values: 1.13 mg/L

Algae:

Pseudokirchneriella subcapitata: 48h-EC50= 0.826 mg/L (measured concentrations)

QSAR estimation based on Mode of Action 1: 72h-EC50= 0.70 mg/L

Based on available data, the lowest acute aquatic toxicity values range between 0.1 and 1.0 mg/L. The long-term toxicity of the substance to aquatic organisms was not investigated. Thus, there are no adequate chronic toxicity data available.

Biodegradation:

(-)-beta-Pinene was found to be readily biodegradable (biodegradation by activated sludge > 60% ThOD) in an OECD 301D closed bottle test (van Ginkel, 2010).

Information on bioaccumulation potential:

The estimated fish BCF of (-)-beta-pinene is 838.0 L/kg (geometric mean of results of three QSAR models: 1140.2 L/kg, 1125.0 L/kg, 383.1 L/kg).

Therefore, no bioaccumulation potential is expected.

CLP self-classification for environment

Based on the results above, (-)-beta-pinene has to be classified as follows:

Acute aquatic hazard: Category 1. M-Factor: 1.

Reasoning: lowest E(L) C50 between 0.1 and 1.0 mg/L.

Chronic aquatic hazard: Category 1. M-Factor: 1.

Reasoning: adequate chronic toxicity data are not available, lowest acute E(L)C50 value range between 0.1 and 1.0 mg/L, readily degradable substance with log Kow > 4.

DSD self-classification for environment

Based on the results above, (-)-beta-pinene has to be classified as follows:

N; R50/53. Reasoning: lowest acute E(L)C50 value range between 0.1 and 1.0 mg/L, readily biodegradable substance with log Kow > 3.