Registration Dossier

Administrative data

Description of key information

Acute oral toxicity (similar to OECD TG 401): LD50 >5000 mg/kg bw

Acute dermal toxicity (similar to OECD TG 402): 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:
no data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Test was conducted according to methods similar to OECD guideline 401 (limit test) and was performed pre-GLP.
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
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
- Batch No.of test material: EOA 75-12


TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: none

Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
Not Specified
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
Not Specified, sex not specified
Doses:
one limit dose of 5000 mg/kg bw
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: Daily
- Necropsy of survivors performed: yes
- Other examinations performed: symptomatology
Preliminary study:
Not relevant
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was noted
Clinical signs:
No effects observed
Body weight:
No data available
Gross pathology:
No effects mentioned
Other findings:
Not other effects were reported.
Interpretation of results:
other: not classified
Remarks:
based on CLP Regulation (1272/2008/EC).
Conclusions:
The oral LD50 value of Cedarwood Texas oilin rats was established as exceeding 5000 mg/kg body weight, under the conditions of this study. The substance therefore does not need to be classified in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).
Executive summary:

A single 5000 mg/kg bw dose of Cedarwood Texas oil was administered by oral gavage to 10 rats. The animals were observed for 14 days. No symptoms or mortality were noted. The oral LD50 value of

Cedarwood Texas oil in rats was established as exceeding 5000 mg/kg body weight, under the conditions of this study.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
Test was conducted according to methods similar to OECD guideline 401 (limit test) and was performed pre-GLP.

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:

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:
no data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Test was conducted according to methods similar to OECD guideline 402 (limit test) and was performed pre-GLP.
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
Limit test
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
- Batch No.of test material: EOA 75-12

Species:
rabbit
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
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

Duration of exposure:
24h
Doses:
5000 mg/kg
No. of animals per sex per dose:
10 animals per dose, sex not specified
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: daily
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
none
Clinical signs:
none
Body weight:
not specified
Gross pathology:
no effects reported
Other findings:
none
Interpretation of results:
other: Not classified
Remarks:
Based on the CLP Regulation (1272/2008/EC).
Conclusions:
The dermal LD50 value of Cedarwood Texas Oil in rabbits was established as exceeding 5000 mg/kg body weight, under the conditions of this study. The substance therefore does not need to be classified according to the classification criteria outlined in annex 1 of CLP Regulation 1272/2008/EC (CLP).
Executive summary:

10 Rabbits were dermally exposed to 5000 mg/kg bw dose of Cedarwood Texas Oil. The animals were observed for 14 days. No symptoms or mortality were noted. The dermal LD50 value of Cedarwood Texas Oil in rabbits was established as exceeding 5000 mg/kg body weight, under the conditions of this study.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
Test was conducted according to methods similar to OECD guideline 402 (limit test) and was performed pre-GLP.

Additional information

Acute oral toxicity

A single 5000 mg/kg bw dose of Cedarwood Texas oil was administered by oral gavage to 10 rats. The animals were observed for 14 days. No symptoms or mortality were noted. The oral LD50 value of Cedarwood Texas oil in rats was established as exceeding 5000 mg/kg body weight, under the conditions of this study.

Acute dermal toxicity

10 Rabbits were dermally exposed to 5000 mg/kg bw dose of Cedarwood Texas Oil. The animals were observed for 14 days. No symptoms or mortality were noted. The dermal LD50 value of Cedarwood Texas Oil in rabbits was established as exceeding 5000 mg/kg body weight, under the conditions of this study.

Justification for classification or non-classification

Based on the available information, the substance Cedarwood Texas oil does not need to be classified for acute toxicity according criteria outlined in annex 1 of CLP Regulation 1272/2008/EC (CLP).