Essential oil of Cinnamomum camphora (Lauraceae) obtained from leaves by steam distillation

Endpoint summary

Description of key information

Acute toxicity, oral: LD50 = 5100 mg/kg bw (read-across with Camphor white oil, K, Rel.2).

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Reference 1

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1971

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

Principles of method if other than guideline:

Standard acute method

GLP compliance:

no

Remarks:

pre-GLP

Test type:

standard acute method

Limit test:

no

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 150-300 g
- Housing: Animals were individually housed
- Diet: Commercial diets, ad libitum
- Water: Water, ad libitum
- Fasting period before study: Overnight fasting

Route of administration:

oral: gavage

Vehicle:

corn oil

Remarks:

50 % (w/v or v/v)

Doses:

1 to 6.81 mL/kg bw

No. of animals per sex per dose:

2 animals for the preliminary study
5 animals for the main study (LD50 determination)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: Animals were observed for toxic signs and mortality at 1 and 4 h and once daily thereafter for for 14 days.
- Necropsy performed: Yes; gross necropsy was performed on any animal that died during the study and on survivors which were killed by cervical dislocation at termination and macroscopic examination was performed.

Statistics:

- LD50 value was calculated according to Horn's method.

Preliminary study:

at 5000 mg/kg bw, 2/2 rats died.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

5 100 mg/kg bw

Based on:

test mat.

95% CL:

2 730 - 7 470

Mortality:

No detail on the mortality in the main test

Clinical signs:

other: - Toxic signs observed were bloody crust eyes and nose, dyspnea, depression and ataxia.

Gross pathology:

- At ≥2.15 mL/kg bw, the dead rats had darkened lungs and gas and fluid in gastrointestinal tract.
- No gross lesions were observed in animals killed at termination.

Other findings:

None

None

Interpretation of results:

GHS criteria not met

Conclusions:

Under the test conditions, the oral LD50 for Camphor oil is 5100 mg/kg bw (C.I. 2730-7470) in rats therefore it is not classified according to the Regulation (EC) No.1272/2008 (CLP) and GHS.

Executive summary:

In an acute oral toxicity study, a preliminary test was performed on two rats with a single dose of Camphor oil at 5000 mg/kg bw. Mortality was observed in 2/2 animals. Therefore the LD50 was determined in further animals (6 groups of 5 rats/dose). The rats were given a single oral dose of Camphor oil at 1 to 6.81 mL/kg bw. Animals were then observed for mortality and clinical signs for 14 days and were all sacrificed for macroscopic examination.

Toxic signs observed were bloody crust eyes and nose, dyspnea, depression and ataxia. At ≥2.15 mL/kg bw, the dead rats had darkened lungs and gas and fluid in gastrointestinal tract. No gross lesions were observed in animals killed at termination. In this study, the oral LD50 of test item was calculated to be 5100 mg/kg bw (C.I. 2730 -7470) in rats by the Horn's method.  

Under the test conditions, the oral LD50 for the registered substance is 5100 mg/kg bw (C.I. 2730 -7470) in rats therefore it is not classified according to the Regulation (EC) No. 1272/2008 (CLP) and GHS.

Reference 2

Endpoint:

acute toxicity: oral

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

Source substance and target substance have the same botanical origin and have many constituents in common (see read-across justification in section 13)

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across: supporting information

Preliminary study:

at 5000 mg/kg bw, 2/2 rats died.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

5 100 mg/kg bw

Based on:

test mat.

95% CL:

>= 2 730 - <= 7 470

Mortality:

No detail on the mortality in the main test

Clinical signs:

other: - Toxic signs observed were bloody crust eyes and nose, dyspnea, depression and ataxia.

Gross pathology:

- At ≥2.15 mL/kg bw, the dead rats had darkened lungs and gas and fluid in gastrointestinal tract.
- No gross lesions were observed in animals killed at termination.

Other findings:

None

None

Interpretation of results:

GHS criteria not met

Conclusions:

Under the test conditions, the oral LD50 for Camphor oil is 5100 mg/kg bw (C.I. 2730-7470) in rats therefore it is not classified according to the Regulation (EC) No.1272/2008 (CLP) and according to GHS. As the source substance represents a worse case for acute oral toxicity of the target substance, it is considered that the registered substance also does not require classification according to CLP and GHS.

Executive summary:

In an acute oral toxicity study, a preliminary test was performed on two rats with a single dose of Camphor oil at 5000 mg/kg bw. Mortality was observed in 2/2 animals. Therefore the LD50 was determined in further animals (6 groups of 5 rats/dose). The rats were given a single oral dose of Camphor oil at 1 to 6.81 mL/kg bw. Animals were then observed for mortality and clinical signs for 14 days and were all sacrificed for macroscopic examination.

Toxic signs observed were bloody crust eyes and nose, dyspnea, depression and ataxia. At ≥2.15 mL/kg bw, the dead rats had darkened lungs and gas and fluid in gastrointestinal tract. No gross lesions were observed in animals killed at termination. In this study, the oral LD50 of test item was calculated to be 5100 mg/kg bw (C.I. 2730 -7470) in rats by the Horn's method.  

Under the test conditions, the oral LD50 for the registered substance is 5100 mg/kg bw (C.I. 2730 -7470) in rats therefore it is not classified according to the Regulation (EC) No. 1272/2008 (CLP) and GHS. As the source substance represents a worse case for acute oral toxicity of the target substance, it is considered that the registered substance also does not require classification according to CLP and GHS.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

5 100 mg/kg bw

Quality of whole database:

Basic data given, but considered sufficiently reliable for the purpose of 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:

A key study was identified (Wong, 1971, Rel. 2). In this acute oral toxicity study, a preliminary test was performed on two rats with a single dose of Camphor oil at 5000 mg/kg bw. Mortality was observed in 2/2 animals. Therefore the LD50 was determined in further animals (6 groups of 5 rats/dose). The rats were given a single oral dose of Camphor oil at 1 to 6.81 mL/kg bw. Animals were then observed for mortality and clinical signs for 14 days and were all sacrificed for macroscopic examination.

Toxic signs observed were bloody crust eyes and nose, dyspnea, depression and ataxia. At ≥2.15 mL/kg bw, the dead rats had darkened lungs and gas and fluid in gastrointestinal tract. No gross lesions were observed in animals killed at termination. In this study, the oral LD50 of test item was calculated to be 5100 mg/kg bw (C.I. 2730 -7470) in rats by the Horn's method.

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 as the LD50 is greater than 5000 mg/kg bw

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 the typical composition provided by the Lead Registrant (> 10% of aspiration toxicants, i.e. alpha/beta-pinene, myrcene), the registered substance should be classified for aspiration hazard:

- H304, May be fatal if swallowed and enters airways according to the regulation (EC) No. 1272/2008