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Description of key information

Acute oral toxicity: 

The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats for the test chemical. The LD50 value is 6160 mg/kg bw. The study concluded that LD50 is >2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity.

Acute Inhalation Toxicity:

The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to the low vapour pressure of the test chemical, which is reported to be 0.0412 mm Hg. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver. 

Acute Dermal toxicity:

The acute dermal toxicity dose (LD50) was considered based on different studies conducted on rats for the test chemical. The studies concluded that LD50 value is >5000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Remarks:
experimental data from various test chemicals
Justification for type of information:
Data is summarized based on the available information from various test chemicals.
Reason / purpose:
read-across source
Reason / purpose:
read-across source
Reason / purpose:
read-across source
Qualifier:
according to
Guideline:
other: As mentioned below
Principles of method if other than guideline:
WoE report is based on 3 acute oral toxicity studies as - WoE 2, WoE 3 and WoE 4.
Acute Oral toxicity test was carried out to study the effects of the test chemicals on rodents.
GLP compliance:
not specified
Test type:
other: not specified
Limit test:
no
Specific details on test material used for the study:
- Name of test material: Isolongifolene
- IUPAC name: (2S)-1,3,4,5,6,7-hexahydro-1,1,5,5-tetramethyl-2H-2,4a-methanonaphthalene
- Molecular formula: C15H24
- Molecular weight: 204.3546 g/mole
- Smiles :CC1(C)CCC=C2C(C)(C)[C@H]3CC[C@@]12C3
- Inchl: 1S/C15H24/c1-13(2)8-5-6-12-14(3,4)11-7-9-15(12,13)10-11/h6,11H,5,7-10H2,1-4H3/t11-,15-/m0/s1
- Substance type: Organic
- Physical state: Liquid (colorless)
Species:
rat
Strain:
other: 1. Osborne-Mendel 2. not specified 3. Osborne-Mendel
Sex:
male/female
Details on test animals and environmental conditions:
1. Details on test animal
TEST ANIMALS
- Age at study initiation: young and adult rats
- Fasting period before study: approximately 18 hr
- Diet (e.g. ad libitum):diet was provided ad libitum
- Water (e.g. ad libitum): water was provided ad libitum
2. not specified
3. Details on test animal
TEST ANIMALS
- Age at study initiation: young and adult rats
- Fasting period before study: approximately 18 hr
- Diet (e.g. ad libitum):diet was provided ad libitum
- Water (e.g. ad libitum): water was provided ad libitum
Route of administration:
other: 1. oral: gavage 2. oral: unspecified 3. oral: gavage
Vehicle:
other: 1. unchanged (no vehicle) 2. unchanged (no vehicle) 3. unchanged (no vehicle)
Details on oral exposure:
1. not specified
2. not specified
3. No data available
Doses:
1. 6160 mg/kg bw
2. 4400 mg/kg bw
3. 2480 mg/kg bw
No. of animals per sex per dose:
1. Groups of 10 males and 10 females
2. not specified
3. groups of 10 males and 10 females
Control animals:
not specified
Details on study design:
1. Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: All animals were maintained under close observation for recording toxic signs and time of death.
- Other examinations performed: clinical signs
2. not specified
3. Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: All animals were maintained under close observation for recording toxic signs and time of death.
- Other examinations performed: clinical signs
Statistics:
1. LD50'S were computed by the method of Litchfield & Wilcoxon (1949).
2. not specified
3. LD50'S were computed by the method of Litchfield & Wilcoxon (1949).
Preliminary study:
1. not specified
2. not specified
3. No data available
Sex:
male/female
Dose descriptor:
LD50
Effect level:
6 160 mg/kg bw
Based on:
test mat.
95% CL:
4 400 - 8 630
Remarks on result:
other: 50% mortality was observed
Sex:
not specified
Dose descriptor:
LD50
Effect level:
4 400 mg/kg bw
Based on:
test mat.
Remarks on result:
other: 50% mortality was observed
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 480 mg/kg bw
Based on:
test mat.
95% CL:
2 100 - 2 930
Remarks on result:
other: 50% mortality was observed
Mortality:
1. Death time was observed from 4 hours to 9 days
2. 50% mortality was observed at 4400 mg/kg bw
3. Death time was observed from 2 hours to 4 days.
Clinical signs:
1. Clinical signs like Depression, scrawny appearance, porphyrin-like deposit around eyes and nose for a week after treatment were observed.
2. not specified
3. Clinical signs like Depression, coma on high doses,scrawny appearance for 3-4 days. All animals recovered within 7 days.
Body weight:
1. not specified
2. not specified
3. No data available
Gross pathology:
1. not specified
2. not specified
3. No data available
Other findings:
1. not specified
2. not specified
3. No data available
Interpretation of results:
other: Not classified
Conclusions:
According to CLP regulation, the test chemical cannot be classified for acute oral toxicity, as the LD50 value is >2000 mg/kg bw.
Executive summary:

In different studies, the given test chemical has been investigated for acute oral toxicity to a greater or lesser extent. Often are the studies based on in-vivo experiments in rodents,

i.e. most commonly in rats for test chemical. The studies are summarized as below –

1. Acute oral toxicity study was performed in group of 10 male and female Osborne-Mendel rats using test chemical. Death time was observed from 4 hours to 9 days. Clinical signs like Depression, scrawny appearance, porphyrin-like deposit around eyes and nose for a week after treatment were observed. Hence, LD50 value was considered to be 6160 mg/kg bw (95% confidence limits: 4400-8630 mg/kg bw), when groups of 10 male and female Osborne-Mendel rats were treated with the given test chemical orally via gavage.

2. Acute oral toxicity study of the given test chemical was conducted in rats at the concentration of 4400 mg/kg bw. 50% mortality was observed at 4400 mg/kg bw. Therefore, LD50 value was considered to be 4400 mg/kg bw, when rats were treated with test chemical via oral route.

3. Acute oral toxicity study was performed in group of 10 male and female Osborne-Mendel rats using test chemical. Death time was observed from 2 hours to 4 days. Clinical signs like Depression, coma on high doses, scrawny appearance for 3-4 days. All animals recovered within 7 days. Hence, LD50 value was considered to be 2480 mg/kg bw (95% confidence limits: 2100-2930 mg/kg bw), when groups of 10 male and female Osborne-Mendel rats were treated with the given test chemical orally via gavage.

Thus, based on the above summarised studies on test chemical, it can be concluded that LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
6 160 mg/kg bw
Quality of whole database:
Data is Klimisch 2 and from peer-reviewed journal.

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
other justification
Justification for data waiving:
other:
Endpoint conclusion
Quality of whole database:
Waiver

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Remarks:
experimental data from various test chemicals
Justification for type of information:
Data is summarized based on the available information from various test chemicals.
Reason / purpose:
read-across source
Reason / purpose:
read-across source
Reason / purpose:
read-across source
Qualifier:
according to
Guideline:
other: As mentioned below
Principles of method if other than guideline:
WoE report is based on 3 acute dermal toxicity studies as- WoE 2, WoE 3 and WoE 4.
Acute dermal toxicity test was carried out to study the effects of the test chemicals on rodents.
GLP compliance:
not specified
Test type:
other: not specified
Limit test:
no
Specific details on test material used for the study:
- Name of test material: Isolongifolene
- IUPAC name: (2S)-1,3,4,5,6,7-hexahydro-1,1,5,5-tetramethyl-2H-2,4a-methanonaphthalene
- Molecular formula: C15H24
- Molecular weight: 204.3546 g/mole
- Smiles :CC1(C)CCC=C2C(C)(C)[C@H]3CC[C@@]12C3
- Inchl: 1S/C15H24/c1-13(2)8-5-6-12-14(3,4)11-7-9-15(12,13)10-11/h6,11H,5,7-10H2,1-4H3/t11-,15-/m0/s1
- Substance type: Organic
- Physical state: Liquid (colorless)
Species:
rabbit
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
1. not specified
2. not specified
3. not specified
Type of coverage:
other: Dermal
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
1. not specified
2. not specified
3. not specified
Duration of exposure:
1. not specified
2. not specified
3. not specified
Doses:
1. 5000 mg/kg bw
2. 5000 mg/kg
3. 5000 mg/kg bw
No. of animals per sex per dose:
1. not specified
2. not specified
3. not specified
Control animals:
not specified
Details on study design:
1. not specified
2. not specified
3. not specified
Statistics:
1. not specified
2. not specified
3. not specified
Preliminary study:
1. not specified
2. not specified
3. not specified
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality was observed
Mortality:
1. No mortality was observed at 5000 mg/kg bw.
2. No mortality was observed at 5000 mg/kg bw.
3. No mortality was observed at 5000 mg/kg bw.
Clinical signs:
1. not specified
2. not specified
3. not specified
Body weight:
1. not specified
2. not specified
3. not specified
Gross pathology:
1. not specified
2. not specified
3. not specified
Other findings:
1. not specified
2. not specified
3. not specified
Interpretation of results:
other: Not classified
Conclusions:
According to CLP regulation, the test chemical cannot be classified for acute dermal toxicity, as the LD50 value is >2000 mg/kg bw.
Executive summary:

In different studies, the given test chemical has been investigated for acute dermal toxicity to a greater or lesser extent. Often are the studies based on in-vivo experiments in rodents, i.e. most commonly in rats for test chemical. The studies are summarized as below –

1. Acute Dermal toxicity study of the given test chemical was conducted in rabbits at the concentration of 5000 mg/kg bw. No mortality was observed at 5000 mg/kg bw. Therefore, LD50 value was considered to be >5000 mg/kg bw, when rabbits were treated with test chemical by dermal application.

2. Acute Dermal toxicity study of the given test chemical was conducted in rabbits at the concentration of 5000 mg/kg bw. No mortality was observed in treated rabbits at 5000 mg/kg bw. Therefore, LD50 was considered to be >5000 mg/kg bw, when rabbits were treated with the given test chemical by dermal application.

3. Acute Dermal toxicity study of the given test chemical was conducted in rabbits at the concentration of 5000 mg/kg bw. No mortality was observed at 5000 mg/kg bw. Therefore, LD50 value was considered to be >5000 mg/kg bw, when rabbits were treated with test chemical by dermal application.

Thus, based on the above summarised studies on test chemical, it can be concluded that LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
5 000 mg/kg bw
Quality of whole database:
Data is Klimisch 2 and from publication.

Additional information

Acute oral toxicity:

In different studies, the given test chemical has been investigated for acute oral toxicity to a greater or lesser extent. Often are the studies based on in-vivo experiments in rodents,

i.e. most commonly in rats for test chemical. The studies are summarized as below –

1. Acute oral toxicity study was performed in group of 10 male and female Osborne-Mendel rats using test chemical. Death time was observed from 4 hours to 9 days. Clinical signs like Depression, scrawny appearance, porphyrin-like deposit around eyes and nose for a week after treatment were observed. Hence, LD50 value was considered to be 6160 mg/kg bw (95% confidence limits: 4400-8630 mg/kg bw), when groups of 10 male and female Osborne-Mendel rats were treated with the given test chemical orally via gavage.

2. Acute oral toxicity study of the given test chemical was conducted in rats at the concentration of 4400 mg/kg bw. 50% mortality was observed at 4400 mg/kg bw. Therefore, LD50 value was considered to be 4400 mg/kg bw, when rats were treated with test chemical via oral route.

3. Acute oral toxicity study was performed in group of 10 male and female Osborne-Mendel rats using test chemical. Death time was observed from 2 hours to 4 days. Clinical signs like Depression, coma on high doses, scrawny appearance for 3-4 days. All animals recovered within 7 days. Hence, LD50 value was considered to be 2480 mg/kg bw (95% confidence limits: 2100-2930 mg/kg bw), when groups of 10 male and female Osborne-Mendel rats were treated with the given test chemical orally via gavage.

Thus, based on the above summarised studies on test chemical, it can be concluded that LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity.

Acute Inhalation Toxicity:

The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to the low vapour pressure of the test chemical, which is reported to be 0.0412 mm Hg. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver. 

Acute Dermal Toxicity:

In different studies, the given test chemical has been investigated for acute dermal toxicity to a greater or lesser extent. Often are the studies based on in-vivo experiments in rodents, i.e. most commonly in rats for test chemical. The studies are summarized as below –

1. Acute Dermal toxicity study of the given test chemical was conducted in rabbits at the concentration of 5000 mg/kg bw. No mortality was observed at 5000 mg/kg bw. Therefore, LD50 value was considered to be >5000 mg/kg bw, when rabbits were treated with test chemical by dermal application.

2. Acute Dermal toxicity study of the given test chemical was conducted in rabbits at the concentration of 5000 mg/kg bw. No mortality was observed in treated rabbits at 5000 mg/kg bw. Therefore, LD50 was considered to be >5000 mg/kg bw, when rabbits were treated with the given test chemical by dermal application.

3. Acute Dermal toxicity study of the given test chemical was conducted in rabbits at the concentration of 5000 mg/kg bw. No mortality was observed at 5000 mg/kg bw. Therefore, LD50 value was considered to be >5000 mg/kg bw, when rabbits were treated with test chemical by dermal application.

Thus, based on the above summarised studies on test chemical, it can be concluded that LD50 value is >5000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity.

Justification for classification or non-classification

Based on the above studies on test chemical, it can be concluded that LD50 value is >2000 mg/kg bw, for acute oral and acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral and acute dermal toxicity. For acute inhalation toxicity wavier was added so, not possible to classify.