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Toxicological information

Acute Toxicity: oral

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Administrative data

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
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1971
Report Date:
1971

Materials and methods

Principles of method if other than guideline:
Standard acute method
GLP compliance:
no
Remarks:
pre-GLP
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
- Name of test material (as cited in study report): Camphor oil
- Physical state: Clear yellow liquid
- Source: Research Institute for Fragrance Materials, Inc., USA
- Date of receipt: 05 May 1971

Test animals

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

Administration / exposure

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.

Results and discussion

Preliminary study:
at 5000 mg/kg bw, 2/2 rats died.
Effect levels
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

Any other information on results incl. tables

None

Applicant's summary and conclusion

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.