Registration Dossier

Administrative data

Description of key information

Acute oral toxicity: pre- GLP, similar to OECD 401, single dose by gavage, male Wistar rat, LD50> 5000 mg/kg bw.

Acute dermal toxicity: pre- GLP, similar to OECD 402, single dose by gavage, female New Zeland white rabbit, LD50> 5000 mg/kg bw.

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:
July 1973
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
- Principle of test: A single 5000 mg/kg bw dose of Cedarwood Virginia was administered by oral gavage to 10 male Wistar rats. The animals were observed for 14 days.
GLP compliance:
no
Remarks:
pre-glp
Test type:
standard acute method
Limit test:
yes
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- h No.of test material: Sample marking: 73-9
Species:
rat
Strain:
Wistar
Sex:
not specified
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
10
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: Daily
- Necropsy of survivors performed: not specified
- Other examinations performed: general symptomatology
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
None
Clinical signs:
slight lethargy
Body weight:
not specified
Gross pathology:
not specified
Other findings:
not specified
Interpretation of results:
other: not classified
Remarks:
based on CLP criteria
Conclusions:
The oral LD50 of Cedarwood Virginia was determined to be higher than 5000 mg/kg bw. Based on the available information, the test substance does not need to be classified for acute oral toxicity, according to the classification criteria outlined in Annex I of 1272/2008/EC (CLP).
Executive summary:

A single 5000 mg/kg bw dose of Cedarwood Virginia was administered by oral gavage to 10 male Wistar rats. The animals were observed for 14 days. Mortality was not noted. Slight lethargy was seen in animals dosed with the test material. The oral LD50 value of Cedarwood Virginia in rats was established as exceeding 5000 mg/kg body weight, under the conditions of this study. Based on the available information, the test substance does not need to be classified for acute oral toxicity, according to the classification criteria outlined in Annex I of 1272/2008/EC (CLP).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
5 000 mg/kg bw
Quality of whole database:
The study available in this dossier adressing this endpoint, is an older pre- GLP, and pre-OECD study, conducted according to methods similar to OECD guideline 401 (limit test) and it is considered appropriate to be used as the basis for the chemical safety assessment.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
July 1973
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Principles of method if other than guideline:
- Principle of test: In this limit test, a high dose of 5000 mg.kg bw Cedarwood Virginia was applied dermally to the skin of 9 rabbits. The rabbits were observed for 14 days.
GLP compliance:
no
Remarks:
pre GLP
Test type:
standard acute method
Limit test:
yes
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- No.of test material: Sample marking: 73-9
Species:
rabbit
Strain:
New Zealand White
Sex:
not specified
Type of coverage:
not specified
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5000 mg/kg bw
- Concentration (if solution): undiluted
Duration of exposure:
not specified
Doses:
Limit dose: 5000 mg/kg bw
No. of animals per sex per dose:
9
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations : daily
- Necropsy of survivors performed: not specified
- Other examinations performed: Skin irritation, others not specified
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
None
Clinical signs:
Slight redness - 7/9
Moderate redness - 1/9
Slight edema - 3/9
Moderate edema - 6/9



Body weight:
not specified
Gross pathology:
not specified
Other findings:
not specified
Interpretation of results:
other: not classified
Remarks:
based on CLP criteria
Conclusions:
The dermal LD50 of Cedarwood Virginia were determined to be higher than 5000 mg/kg bw. Based on the available information, the test substance does not need to be classified for acute dermal toxicity, according to the classification criteria outlined in Annex I of 1272/2008/EC (CLP).
Executive summary:

In this limit test, a high dose of 5000 mg.kg bw Cedarwood Virginia was applied dermally to the skin of 9 rabbits. The rabbits were observed for 14 days. No mortality was observed, and the LD50 was established to be higher than 5000 mg/kg bw. Based on the available information, the test substance does not need to be classified for acute dermal toxicity, according to the classification criteria outlined in Annex I of 1272/2008/EC (CLP)

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
5 000 mg/kg bw
Quality of whole database:
The study available in this dossier adressing this endpoint, is an older pre- GLP, and pre-OECD study, conducted according to methods similar to OECD guideline 402 and it is considered appropriate to be used as the basis for the chemical safety assessment.

Additional information

Acute oral toxicity

A single 5000 mg/kg bw dose of Cedarwood Virginia was administered by oral gavage to 10 male Wistar rats. The animals were observed for 14 days. Mortality was not noted. Slight lethargy was seen in animals dosed with the test material. The oral LD50 value of Cedarwood Virginia in rats was established as exceeding 5000 mg/kg body weight, under the conditions of this study.

Acute dermal toxicity

In this limit test, a high dose of 5000 mg.kg bw Cedarwood Virginia was applied dermally to the skin of 9 rabbits. The rabbits were observed for 14 days. No mortality was observed, and the LD50 was established to be higher than 5000 mg/kg bw.

Justification for classification or non-classification

The oral and dermal LD50 of Cedarwood Virginia were determined to be higher than 5000 mg/kg bw. Based on the available information, the test substance does not need to be classified for acute oral and dermal toxicity, according to the classification criteria outlined in Annex I of 1272/2008/EC (CLP).