Registration Dossier

Administrative data

Description of key information

Acute toxicity, oral in rats: LD50 > 2000 mg/kg bw (read-across substance: Cistus concrete; OECD 420, GLP, W, Rel. 1)

Acute toxicity, oral in rats: LD50 > 2000 mg/kg bw (read-across substance: Pinus pinaster oil; OECD 420, GLP, W, Rel. 1)

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Justification for type of information:
The source substance represents a worse case towards acute oral toxicity for the target substance because it contains more constituents classified for acute oral toxicity than the registered substance.
Reason / purpose:
read-across source
Reason / purpose:
read-across: supporting information
Preliminary study:
- No mortality and systemic toxicity were observed in the initial animal treated at 300 and 2000 mg/kg bw dose
- Animal showed expected gains in body weight over the observation period
- No abnormality was noted at necropsy
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality was observed
Mortality:
- No mortality was observed
Clinical signs:
- Hunched posture and increased salivation were observed in the additional four animals treated at 2000 mg/kg bw and one of these animals showed noisy respiration.
Body weight:
- All animals showed expected gains in body weight over the observation period
Gross pathology:
- No abnormalities were noted at necropsy.
Other findings:
None

None

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the test conditions, the oral LD50 for Pinus Pinaster oil is higher than 2000 mg/kg bw in rats therefore it is not classified according to the Directive 67/548/EEC and the Regulation (EC) N° 1272-2008. Therefore the registered substance is also not considered to require any classification for acute oral toxicity.
Executive summary:

In an acute oral toxicity study performed according to OECD Guideline 420 and in compliance with GLP, a group of five female Wistar (RccHan™:WIST) rats were given a single oral dose of the test item Pinus Pinaster oil at 2000 mg/kg bw. Animals were then observed for mortality, clinical signs and bodyweights for 14 days and were all sacrificed for macroscopic examination. Before the main test, a sighting test was also conducted on 1 female rat/dose at 300 and 2000 mg/kg bw and animals were observed for 14 days. As no mortality occurred, the test item was administered to four additional animals at the dose level of 2000 mg/kg bw (main test).

No mortality was observed. No sign of systemic toxicity was observed in the initial animal treated at 300 and 2000 mg/kg bw dose level (sighting study). Signs of systemic toxicity observed in animals of the main study treated at a dose level of 2000 mg/kg bw were hunched posture, increased salivation and noisy respiration. All animals showed expected gains in body weight. No abnormalities were noted at necropsy. In this study, the oral LD50 of Pinus Pinaster oil was considered to be higher than 2000 mg/kg bw in female rats.

Under the test conditions, the oral LD50 for Pinus Pinaster oil is higher than 2000 mg/kg bw in rats therefore it is not classified according to the Directive 67/548/EEC and the Regulation (EC) N° 1272-2008. Therefore the registered substance is also not considered to require any classification for acute oral toxicity.

Endpoint:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Justification for type of information:
The source substance and the target substance have the same botanical origin, Cistus ladaniferus (Cistaceae), and are extracts of the same parts of the plant.
Reason / purpose:
read-across source
Reason / purpose:
read-across: supporting information
Preliminary study:
- No mortality or clinical signs were observed at 300 mg/kg bw.
- The animal showed expected gains in body weight over the observation period.
- No abnormalities were noted at necropsy.
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed at 2000 mg/kg bw.
Clinical signs:
No signs of systemic toxicity were noted during the observation period.
Body weight:
All animals showed expected gains in body weight over the observation period.
Gross pathology:
No abnormalities were noted at necropsy.
Other findings:
None

None

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Rat Oral LD50 (females) > 2000 mg/kg bw
Under the test conditions, the test material is not classified according to the annex VI of the Regulation EC No. 1272/2008 (CLP) and of the Directive 67/548/EEC. Therefore the registered substance is also not considered to require any classification for acute oral toxicity.
Executive summary:

In an acute oral toxicity study performed according to OECD Guideline 420 and in compliance with GLP, groups (5 females/dose) of Wistar (RccHan™:WIST) rats were given a single oral (gavage) dose of test material at 2000 mg/kg bw. Animals were then observed for mortality, clinical signs and bodyweights for 14 days and at the end of the study the surviving animals were sacrificed for macroscopic examination. Sighting study was conducted at the dose levels of 300 and 2000 mg/kg bw (one female/dose) to determine the dose for main study.

 

In the sighting study, no mortality or clinical signs were observed at 300 mg/kg bw. The animal showed expected gains in body weight over the observation period. No abnormalities were noted at necropsy. In the main study, no mortality or clinical signs were observed at 2000 mg/kg bw. All animals showed expected gains in body weight over the observation period. No abnormalities were noted at necropsy.

 

Rat Oral LD50 (females) > 2000 mg/kg bw

 

Under the test conditions, the test material is not classified according to the annex VI of the Regulation EC No. 1272/2008 (CLP) and of the Directive 67/548/EEC. Therefore the registered substance is also not considered to require any classification of acute oral toxicity.

This study is considered as acceptable and satisfies the requirement for acute oral toxicity endpoint.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
2 000 mg/kg bw
Quality of whole database:
Recent GLP studies compliant with OECD guidelines

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

In an acute oral toxicity study performed according to OECD Guideline 420 and in compliance with GLP, groups (5 females/dose) of Wistar (RccHan™:WIST) rats were given a single oral (gavage) dose of test material at 2000 mg/kg bw. Animals were then observed for mortality, clinical signs and bodyweights for 14 days and at the end of the study the surviving animals were sacrificed for macroscopic examination. Sighting study was conducted at the dose levels of 300 and 2000 mg/kg bw (one female/dose) to determine the dose for main study.

 

In the sighting study, no mortality or clinical signs were observed at 300 mg/kg bw. The animal showed expected gains in body weight over the observation period. No abnormalities were noted at necropsy. In the main study, no mortality or clinical signs were observed at 2000 mg/kg bw. All animals showed expected gains in body weight over the observation period. No abnormalities were noted at necropsy.

 

Rat Oral LD50 (females) > 2000 mg/kg bw

 

Under the test conditions, the test material is not classified according to the annex VI of the Regulation EC No. 1272/2008 (CLP) and of the Directive 67/548/EEC.Therefore the registered substance is also not considered to require any classification of acute oral toxicity.

This study is considered as acceptable and satisfies the requirement for acute oral toxicity endpoint.

In an acute oral toxicity study performed according to OECD Guideline 420 and in compliance with GLP, a group of five female Wistar (RccHan™:WIST) rats were given a single oral dose of the test item Pinus Pinaster oil at 2000 mg/kg bw. Animals were then observed for mortality, clinical signs and bodyweights for 14 days and were all sacrificed for macroscopic examination. Before the main test, a sighting test was also conducted on 1 female rat/dose at 300 and 2000 mg/kg bw and animals were observed for 14 days. As no mortality occurred, the test item was administered to four additional animals at the dose level of 2000 mg/kg bw (main test).

No mortality was observed. No sign of systemic toxicity was observed in the initial animal treated at 300 and 2000 mg/kg bw dose level (sighting study). Signs of systemic toxicity observed in animals of the main study treated at a dose level of 2000 mg/kg bw were hunched posture, increased salivation and noisy respiration. All animals showed expected gains in body weight. No abnormalities were noted at necropsy. In this study, the oral LD50 of Pinus Pinaster oil was considered to be higher than 2000 mg/kg bw in female rats.

Under the test conditions, the oral LD50 for Pinus Pinaster oil is higher than 2000 mg/kg bw in rats therefore it is not classified according to the Directive 67/548/EEC and the Regulation (EC) N° 1272-2008.

Justification for classification or non-classification

Harmonized classification:

The registered substance has no harmonized classification according to the Regulation (EC) No. 1272/2008.

Self-classification:

Acute toxicity via Oral route:

Based on the available information, the registered substance is:

- not classified according to the Regulation (EC) No. 1272/2008 and GHS.

Acute toxicity via Dermal route:This information is not available

Acute toxicity via Inhalation:This information is not available.

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). 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.

Based on its composition, the registered substance is not classified for aspiration hazard acording to CLP Regulation and GHS.