Registration Dossier
Registration Dossier
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EC number: 281-679-2 | CAS number: 84012-35-1 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Pinus sylvestris, Pinaceae.
Endpoint summary
Administrative data
Description of key information
Acute toxicity, oral: LD50 > 5000 mg/kg bw (K, Rel.2).
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1975
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given, but considered sufficiently reliable for the purpose of hazard assessment
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Standard acute method (limit test)
- GLP compliance:
- no
- Remarks:
- (pre-GLP)
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- No data
- Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Details on oral exposure:
- No data
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- Total: 10 animals
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: Observations for mortality and toxic effects were made daily for 14 days
- Necropsy of survivors performed: No data - Statistics:
- None
- Preliminary study:
- Not applicable
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No mortality was observed
- Mortality:
- No mortality was observed.
- Clinical signs:
- No clinical signs were observed.
- Body weight:
- No data
- Gross pathology:
- No data
- Other findings:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, oral LD50 of Pinus Oil Sylvestris is higher than 5000 mg/kg bw in rats therefore it must not be classified according to the CLP Regulation (EC) No. 1272/2008 and Globally Harmonized System (GHS).
- Executive summary:
In an acute oral toxicity study (limit test), ten rats were given a single oral dose of Pinus Oil Sylvestris at 5000 mg/kg bw. Animals were then observed for mortality and clinical signs for 14 days.
No mortality and clinical signs were observed. In this study, the oral LD50 of Pinus Oil Sylvestris was higher than 5000 mg/kg bw in rats.
Under the test conditions, oral LD50 of Pinus Oil Sylvestris is higher than 5000 mg/kg bw in rats therefore it must not be classified according to the CLP Regulation (EC) No. 1272/2008 and Globally Harmonized System (GHS).
This study is considered as acceptable and satisfies the requirement for acute oral toxicity endpoint.
Reference
None
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
- Quality of whole database:
- Only basic data given in the available study. However, no death out of ten animals was observed at the dose level of 5000 mg/kg bw, which is 2.5 times more than the limit dose of the OECD 401/423/425. A repeat study is unlikely to show worse effects, therefore this study was considered sufficiently robust to cover this endpoint.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Acute toxicity: via oral route:
A key study was identified (Levenstein, 1975, Rel. 2). In this limit acute oral toxicity study, 10 rats (5/sex) were administered a single oral dose of test material of 5000 mg/kg bw. The animals were observed for mortality for 14 days.
No mortality and no clinical signs was observed.
Oral LD50 of Pine scotch oil was higher than 5000 mg/kg bw in rats.
Justification for classification or non-classification
Harmonized classification:
Pine scotch oil has no harmonized classification according to the Regulation (EC) No. 1272/2008.
Self classification:
Acute toxicity (Oral):
Based on the available information, the substance is:
-not classified according to the CLP as the oral LD50 is higher than 2000 mg/kg bw
-not classified according to the GHS since there is no reliable evidence that indicates the LD50 to be in the range of Category 5 values (GHS criteria not met).
Acute toxicity via Dermal route: This information is not available and not required for this tonnage band.
Acute toxicity via Inhalation: This information is not available and not required for this tonnage band.
Specific target organ toxicity: single exposure (Oral):
The classification criteria according to the Annex VI of the Regulation (EC) No. 1272/2008 as specific target organ toxicant (STOT) – single exposure, oral are not met since no reversible or irreversible adverse health effects were observed immediately or delayed after exposure and no effects were observed at the guidance value (oral) for a Category 1 classification (C ≤ 300 mg/kg bw) and at the guidance value (oral) for a Category 2 classification (2000 mg/kg bw ≥ C > 300 mg/kg bw). Therefore no classification is required.
Specific target organ toxicity: single exposure (Dermal): This information is not available.
Specific target organ toxicity: single exposure (Inhalation): This information is not available.
According to the Regulation (EC) No. 1272/2008, Substances in Category 1 for aspiration hasard include but are not limited to certain hydrocarbons, turpentine and pine oil. Based on its composition (> 10% of aspiration toxicants, i.e. pinene, carene-3 -delta), Pine scotch oil should be classified for aspiration hazard:
- H304, May be fatal if swallowed and enters airways according to the regulation (EC) No. 1272/2008 and to the GHS.
Source: ECHA disseminated dossiers
-Pinene alpha:
http://apps.echa.europa.eu/registered/data/dossiers/DISS-9d952924-c8ed-4614-e044-00144f67d249/DISS-9d952924-c8ed-4614-e044-00144f67d249_DISS-9d952924-c8ed-4614-e044-00144f67d249.html
- Pinene beta:
http://apps.echa.europa.eu/registered/data/dossiers/DISS-9d85bc06-0d47-6e67-e044-00144f67d249/DISS-9d85bc06-0d47-6e67-e044-00144f67d249_DISS-9d85bc06-0d47-6e67-e044-00144f67d249.html
- Carene delta 3:
http://apps.echa.europa.eu/registered/data/dossiers/DISS-9ead810f-31dc-543d-e044-00144f67d031/DISS-9ead810f-31dc-543d-e044-00144f67d031_DISS-9ead810f-31dc-543d-e044-00144f67d031.html
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