Registration Dossier

Administrative data

Description of key information

Acute toxicity, oral: LD50 = 5100 mg/kg bw (K, Rel.2).

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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:
reference to same study
Reason / purpose:
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 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:
- Toxic signs observed were bloody crust eyes and nose, dyspnea, depression and ataxia.
Body weight:
No data
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:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
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 Annex VI to the Directive 67/548/EEC and the Regulation (EC) No. 1272/2008 (CLP).
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 Camphor oil is 5100 mg/kg bw (C.I. 2730 -7470) in rats therefore it is not classified according to the Annex VI to the Directive 67/548/EEC and the Regulation (EC) No. 1272/2008 (CLP).
Endpoint conclusion
Endpoint conclusion:
no 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 selection of acute toxicity – oral endpoint
Only one study available

Justification for classification or non-classification

Harmonized classification:

Camphor white oil has no harmonized classification according to the Regulation (EC) No. 1272/2008.

Self-classification:

Acute toxicity via Oral route:

Based on the available information, Camphor white oil is:

- not classified according to the Regulation (EC) No. 1272/2008 as the LD50 is greater than 2000 mg/kg bw

- not classified according to the Directive 67/548/EEC as the LD50 is greater than 2000 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. limonene, pinene, myrcene, cymene-para), Camphor white oil should be classified for aspiration hazard:

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

- Xn, R65, Harmful: may cause lung damage if swallowed according to the Directive 67/548/EEC.

Source: ECHA disseminated dossiers:

-Pinene:

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

- Limonene:

http://apps.echa.europa.eu/registered/data/dossiers/DISS-9eb16d5d-b83e-2831-e044-00144f67d031/DISS-9eb16d5d-b83e-2831-e044-00144f67d031_DISS-9eb16d5d-b83e-2831-e044-00144f67d031.html

-Myrcene:

http://apps.echa.europa.eu/registered/data/dossiers/DISS-9d82fafa-8716-3e64-e044-00144f67d249/DISS-9d82fafa-8716-3e64-e044-00144f67d249_DISS-9d82fafa-8716-3e64-e044-00144f67d249.html

- Cymene-para:

http://apps.echa.europa.eu/registered/data/dossiers/DISS-d7f35eaa-981f-389d-e044-00144f67d031/DISS-d7f35eaa-981f-389d-e044-00144f67d031_DISS-d7f35eaa-981f-389d-e044-00144f67d031.html