Registration Dossier

Administrative data

Description of key information

Acute toxicity, oral in rats: LD50 > 5000 mg/kg bw (read-across substance: olibanum gum;  equivalent or similar to OECD 401, non-GLP, W, Rel. 2)

Acute toxicity, oral in rats: LD50 > 2000 mg/kg bw (read-across substance: Resinoid of Boswellia Carterii (Burseraceae) obtained from exudate by hexane extraction; OECD 423, 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 and the target substance have the same botanical origin.
Reason / purpose:
read-across source
Preliminary study:
Not applicable
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred during the study.
Clinical signs:
An increase of salivation was noted in the first hours of the test in one animal (1/6). Then a decrease of spontaneous activity, muscles tones and righting reflex was noted 24 hours post dose associated with a noisy breathing. The animal recovered normal activity on day 3. No other signs of systemic toxicity were noted.
Body weight:
The body weight evolution of the animals remained normal throughout the study.
Gross pathology:
The macroscopic examination of the animals at the end of the study did not reveal treatment related changes.
Other findings:
None

None

Interpretation of results:
GHS criteria not met
Conclusions:
Under the test conditions, the oral LD50 of the test substance is >2000 mg/kg bw in rats. In accordance with OECD Guideline 423, the LD50 cut-off of the test substance may be considered to be >5000 mg/kg bw by oral route in the rat. Therefore it is not classified according to the Regulation (EC) N° 1272-2008 and according to the Globally Harmonised System of classification and labelling of chemicals (GHS). No signal word or hazard statement is required. Therefore, it is considered that the registered substance does not require classification according to these results.
Executive summary:

In an acute oral toxicity study performed according to the OECD Guideline 423 and in compliance with GLP, a single dose of 2000 mg/kg bw of the test substance in DMSO was given by oral gavage to a group of 6 female Wistar rats. Animals were then observed for mortality and clinical signs of toxicity for 14 days.

No mortality occurred during the study. An increase of salivation was noted in the first hours of the test in one animal (1/6). Then a decrease of spontaneous activity, muscles tones and righting reflex was noted 24 hours post dose associated with a noisy breathing. The animal recovered normal activity on day 3. No other signs of systemic toxicity were noted. The body weight evolution of the animals remained normal during the study. The macroscopic examination of the animals at the end of the study did not reveal any treatment related changes.

Rat Oral LD50 >2000 mg/kg bw.

Under the test conditions, the oral LD50 of the test substance is >2000 mg/kg bw in rats. In accordance with OECD Guideline 423, the LD50 cut-off of the test substance may be considered to be >5000 mg/kg bw by oral route in the rat. Therefore it is not classified according to the Regulation (EC) N° 1272-2008 and according to the Globally Harmonised System of classification and labelling of chemicals (GHS). No signal word or hazard statement is required. Therefore, it is considered that the registered substance does not require classification according to these results.

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.
Reason / purpose:
read-across source
Preliminary study:
Not applicable
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
one autolyzed rat was found
Clinical signs:
No toxic signs were observed.
Body weight:
No data
Gross pathology:
No effect
Other findings:
None

None

Interpretation of results:
GHS criteria not met
Conclusions:
Under the test conditions, oral LD50 of test substance is higher than 5000 mg/kg bw in rats therefore it is not classified according to the Regulation (EC) N° 1272 -2008 and GHS. Therefore it is considered that the registered substance also does not require classification.
Executive summary:

In an acute oral toxicity study (limit test), 2 Sprague Dawley rats (male/female) were given a single oral dose of olibanum gum diluted at 50% in corn oil at 5000 mg/kg bw. Animals were then observed for mortality and clinical signs 1 and 4 h after administration then daily for 14 days. As no deaths occurred, 8 additional rats were given the same dose via the same route.

One autolyzed animal was found. No toxic signs were noted and no effect was recorded at necropsy. In this study, the oral LD50 of test substance was higher than 5000 mg/kg bw in rats.

 

Under the test conditions, oral LD50 of test substance is higher than 5000 mg/kg bw in rats therefore it is not classified according the Regulation (EC) N° 1272 -2008 and GHS. Therefore it is considered that the registered substance also does not require classification.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
2 000 mg/kg bw
Quality of whole database:
Adequate for hazard assessment

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 the OECD Guideline 423 and in compliance with GLP, a single dose of 2000 mg/kg bw of the test substance Resinoid of Boswellia Carterii (Burseraceae) obtained from exudate by hexane extraction

in DMSO was given by oral gavage to a group of 6 female Wistar rats. Animals were then observed for mortality and clinical signs of toxicity for 14 days.

No mortality occurred during the study. An increase of salivation was noted in the first hours of the test in one animal (1/6). Then a decrease of spontaneous activity, muscles tones and righting reflex was noted 24 hours post dose associated with a noisy breathing. The animal recovered normal activity on day 3. No other signs of systemic toxicity were noted. The body weight evolution of the animals remained normal during the study. The macroscopic examination of the animals at the end of the study did not reveal any treatment related changes. Rat Oral LD50 >2000 mg/kg bw.

Under the test conditions, the oral LD50 of the test substance is >2000 mg/kg bw in rats. In accordance with OECD Guideline 423, the LD50 cut-off of the test substance may be considered to be >5000 mg/kg bw by oral route in the rat. Therefore it is not classified according to the Regulation (EC) N° 1272-2008 and according to the Globally Harmonised System of classification and labelling of chemicals (GHS). No signal word or hazard statement is required. Therefore, it is considered that the registered substance does not require classification according to these results.

In an acute oral toxicity study (limit test), 2 Sprague Dawley rats (male/female) were given a single oral dose of olibanum gum diluted at 50% in corn oil at 5000 mg/kg bw. Animals were then observed for mortality and clinical signs 1 and 4 h after administration then daily for 14 days. Asno deaths occurred, 8 additional rats were given the same dose via the same route.

One autolyzed animal was found. No toxic signs were noted and no effect was recorded at necropsy. In this study, the oral LD50 of test substance was higher than 5000 mg/kg bw in rats.

 Under the test conditions, oral LD50 of test substance is higher than 5000 mg/kg bw in rats therefore it is not classified according the Regulation (EC) N° 1272 -2008 and GHS.Therefore it is considered that the registered substance also does not require classification.

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 and its physical state, the registered substance is not classified for aspiration hazard acording to CLP Regulation and GHS.