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Description of key information

Acute oral toxicity (OECDTG401): >5000 mg/kg bw (read-across from Cedarwood Virginia oil)

Acute dermal toxicity (OECDTG402): >5000 mg/kg bw (read-across from Cedarwood Virginia oil)

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Referenceopen allclose all

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:
The full read across justification report is attached under "Attached justification".

20 December 2017 READ-ACROSS STUDY / CW TX TERPENES / ACUTE ORAL TOXICITY I&B9W8768R001F1.0

According to Annex VII, 8.5 of the REACh Regulation (EC) No 1907/2006, acute toxicity by the oral route is standard information required for the registration of substances manufactured or imported in quantities of one tonne per year or more. However, according to Annex XI, 1.5 of the REACH Regulation, Read-across and grouping approaches can be used to adapt the standard testing regime. This read-across study report follows notably the recommendations made by the European Chemicals Agency in its “Guidance on information requirements and chemical safety assessment Chapter R.6 – QSARs and grouping of chemicals” (ECHA, 2008) and in its document “Read-Across Assessment Framework (RAAF)” (ECHA, 2017).

A read-across approach appears appropriate to predict the endpoint “, Acute toxicity by the oral route” for the substance Cedarwood Texas oil distilled - Terpenes (Cedrene and Thujopsene) because:

An acute oral toxicity study, according to OECD test guideline 401, is available for the substance Cedarwood Virginia oil, (CW Virginia), which composition is very similar.

The concentrations of the main constituents cedrene α and β, for which a high toxic hazard is identified, but do not lead to acute oral toxicity classification, are similar in the source Cedarwood Virginia oil; and the concentration of a minor constituent, cuparene, which has been notified for acute hazard by a small number of notifiers in the C&L inventory, is also comparable in source and target UVCB substances.

This report follows the RAAF method and so presents:
1) The hypothesis: analogue read-across approach, based on the similarity of the structures and the absence of acute oral toxicity for these types of structures;
2) The scientific justifications (“Assessment Elements”) and their evaluation (“Assessment Options”); which demonstrate the confidence that can be put in this prediction.
3) The conclusions, usable for classification assessment or risk assessment, which are summarised hereafter.
Reason / purpose for cross-reference:
read-across source
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 acute toxicity of Cedarwood Texas oil distilled - Terpenes was evaluated by read across with the source study for Cedarwood Virginia oil. Based on the available information, the Cedarwood Texas oil distilled - Terpenes 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:

The acute toxicity of Cedarwood Texas oil distilled - Terpenes was evaluated by read across with the source study for Cedarwood Virginia oil. 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:
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:
The full read across justification report is attached under "Attached justification".

According to Annex VII, 8.5 of the REACh Regulation (EC) No 1907/2006, acute toxicity by the oral route is standard information required for the registration of substances manufactured or imported in quantities of one tonne per year or more. However, according to Annex XI, 1.5 of the REACH Regulation, Read-across and grouping approaches can be used to adapt the standard testing regime. This read-across study report follows notably the recommendations made by the European Chemicals Agency in its “Guidance on information requirements and chemical safety assessment Chapter R.6 – QSARs and grouping of chemicals” (ECHA, 2008) and in its document “Read-Across Assessment Framework (RAAF)” (ECHA, 2017).

A read-across approach appears appropriate to predict the endpoint “, Acute toxicity by the oral route” for the substance Cedarwood Texas oil distilled - Terpenes (Cedrene and Thujopsene) because:

An acute oral toxicity study, according to OECD test guideline 401, is available for the substance Cedarwood Virginia oil, (CW Virginia), which composition is very similar.

The concentrations of the main constituents cedrene α and β, for which a high toxic hazard is identified, but do not lead to acute oral toxicity classification, are similar in the source Cedarwood Virginia oil; and the concentration of a minor constituent, cuparene, which has been notified for acute hazard by a small number of notifiers in the C&L inventory, is also comparable in source and target UVCB substances.

This report follows the RAAF method and so presents:
1) The hypothesis: analogue read-across approach, based on the similarity of the structures and the absence of acute oral toxicity for these types of structures;
2) The scientific justifications (“Assessment Elements”) and their evaluation (“Assessment Options”); which demonstrate the confidence that can be put in this prediction.
3) The conclusions, usable for classification assessment or risk assessment, which are summarised hereafter.
Reason / purpose for cross-reference:
read-across source
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 acute toxicity of Cedarwood Texas oil distilled - Terpenes was evaluated by read across with the source study for Cedarwood Virginia oil. Based on the available information, the Cedarwood Texas oil distilled - Terpenes 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:

The acute toxicity of Cedarwood Texas oil distilled - Terpenes was evaluated by read across with the source study for Cedarwood Virginia oil. 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:
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
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 oil 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 oil 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 oil 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
Quality of whole database:
The justification document for read-across is attached to the target record

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

Referenceopen allclose all

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
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:
acute toxicity: dermal
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
The full read across justification report is attached under "Attached justification".

10 April 2018 READ-ACROSS STUDY / CW TX OIL TERPENES (1 & 2) / ACUTE DERMAL TOXICITY I&B9W8768R001F1.0

According to Annex VIII, 8.5 of the REACh Regulation (EC) No 1907/2006, Acute toxicity by the Dermal route is standard information required for the registration of substances manufactured or imported in quantities of 10 tonnes per year or more. However, according to Annex XI, 1.5 of the REACH Regulation, Read-across and grouping approaches can be used to adapt the standard testing regime. This read-across study report follows notably the recommendations made by the European Chemicals Agency in its “Guidance on information requirements and chemical safety assessment Chapter R.6 – QSARs and grouping of chemicals” (ECHA, 2008) and in its document “Read-Across Assessment Framework (RAAF)” (ECHA, 2017).

A read-across approach appears appropriate to predict the endpoint “Acute dermal toxicity” for the substance Cedarwood Texas oil distilled - Terpenes (Cedrene and Thujopsene) because:

An acute dermal toxicity study, according to OECD test guideline 402, is available for the substance Cedarwood Virginia oil, (CW Virginia), which composition is very similar.

The concentrations of the main constituents cedrene α and β, for which a high toxic hazard is identified, but do not lead to acute dermal toxicity classification, are similar in the source Cedarwood Virginia oil; and the concentration of a minor constituent, cuparene, which has been notified for acute hazard by a small number of notifiers in the C&L inventory, is also comparable in source and target UVCB substances.

This report follows the RAAF method and so presents:
1) The hypothesis: analogue read-across approach, based on the similarity of the structures and the absence of Acute dermal toxicity for these types of structures;
2) The scientific justifications (“Assessment Elements”) and their evaluation (“Assessment Options”); which demonstrate the confidence that can be put in this prediction.
3) The conclusions, usable for classification assessment or risk assessment, which are summarised hereafter.
Reason / purpose for cross-reference:
read-across source
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 acute dermal toxicity of Cedarwood Texas oil distilled - Terpenes was evaluated by read across with the source study for Cedarwood Virginia oil. Based on the available information, the Cedarwood Texas oil distilled - Terpenes 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:

The acute dermal toxicity of Cedarwood Texas oil distilled - Terpenes was evaluated by read across with the source study for Cedarwood Virginia oil.

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:
acute toxicity: dermal
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
The full read across justification report is attached under "Attached justification".

10 April 2018 READ-ACROSS STUDY / CW TX OIL TERPENES (1 & 2) / ACUTE DERMAL TOXICITY I&B9W8768R001F1.0


According to Annex VIII, 8.5 of the REACh Regulation (EC) No 1907/2006, Acute toxicity by the Dermal route is standard information required for the registration of substances manufactured or imported in quantities of 10 tonnes per year or more. However, according to Annex XI, 1.5 of the REACH Regulation, Read-across and grouping approaches can be used to adapt the standard testing regime. This read-across study report follows notably the recommendations made by the European Chemicals Agency in its “Guidance on information requirements and chemical safety assessment Chapter R.6 – QSARs and grouping of chemicals” (ECHA, 2008) and in its document “Read-Across Assessment Framework (RAAF)” (ECHA, 2017).

A read-across approach appears appropriate to predict the endpoint “Acute dermal toxicity” for the substance Cedarwood Texas oil distilled - Terpenes (Cedrene and Thujopsene) because:

An acute dermal toxicity study, according to OECD test guideline 402, is available for the substance Cedarwood Virginia oil, (CW Virginia), which composition is very similar.

The concentrations of the main constituents cedrene α and β, for which a high toxic hazard is identified, but do not lead to acute dermal toxicity classification, are similar in the source Cedarwood Virginia oil; and the concentration of a minor constituent, cuparene, which has been notified for acute hazard by a small number of notifiers in the C&L inventory, is also comparable in source and target UVCB substances.

This report follows the RAAF method and so presents:
1) The hypothesis: analogue read-across approach, based on the similarity of the structures and the absence of Acute dermal toxicity for these types of structures;
2) The scientific justifications (“Assessment Elements”) and their evaluation (“Assessment Options”); which demonstrate the confidence that can be put in this prediction.
3) The conclusions, usable for classification assessment or risk assessment, which are summarised hereafter.

Reason / purpose for cross-reference:
read-across source
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 acute dermal toxicity of Cedarwood Texas oil distilled - Terpenes was evaluated by read across with the source study for Cedarwood Virginia oil. Based on the available information, the Cedarwood Texas oil distilled - Terpenes 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:

The acute dermal toxicity of Cedarwood Texas oil distilled - Terpenes was evaluated by read across with the source study for Cedarwood Virginia oil.

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
Quality of whole database:
The justification document for read-across is attached to the target record

Additional information

The acute toxicity of Cedarwood Texas Terpenes was assessed by using read across from Cedarwood Virginia oil. The summary of the studie is presented below, and the read across justifications are attached to the acute toxicity target records.

Acute oral toxicity (OECDTG401, Cedarwood Virginia oil)

A single 5000 mg/kg bw dose of Cedarwood Virginia oil 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 oil 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).

Acute dermal toxicity (OECDTG402, Cedarwood Virginia oil)

The acute dermal toxicity of Cedarwood Texas oil distilled - Terpenes was evaluated by read across with the source study for Cedarwood Virginia oil.

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)

Justification for classification or non-classification

The acute toxicity of Cedarwood Texas oil distilled - Terpenes was evaluated by read across with the source study for Cedarwood Virginia oil.

Based on the available read across data, the substance does not need to be classified for acute toxicity in accordance to EU CLP (1272/2008 and its amendments).