[3R-(3α,3aβ,6α,7β,8aα)]-octahydro-6-methoxy-3,6,8,8-tetramethyl-1H-3a,7-methanoazulene

Endpoint summary

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

Acute inhalation toxicity: route to route extrapolation from oral: > 13000 mg/m3.

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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

not specified

Sex:

not specified

Route of administration:

oral: unspecified

Vehicle:

not specified

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

10 animals per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality observed

Clinical signs:

No clinical signs observed

Interpretation of results:

other: not orally acutely toxic

Remarks:

EU CLP criteria

Conclusions:

The acute oral toxicity test showed an LD50 of > 5000 mg/kg bw

Executive summary:

In a pre-GLP acute toxicity study similar to OECD 401, 10 rats were orally exposed to 5000 mg/kg bw test substance. All animals survived the 14 -day observation period. Under the conditions of the test the acute oral LD50 was determined to be >5000 mg/kg bw in rats.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

The study is considered to be a reliability 2 study since it predates GLP but is similar to OECD TG 401.

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

other justification

Justification for data waiving:

the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size

other:

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Species:

rabbit

Strain:

not specified

Sex:

not specified

Type of coverage:

not specified

Vehicle:

unchanged (no vehicle)

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

10 animals per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality observed

Other findings:

Skin irritation: Slight redness 5 out of 10; Moderate redness 5 out of 10; Slight edema 4 out of 10; Moderate edema 6 out of 10

Interpretation of results:

other: not dermally acutely toxic

Remarks:

EU CLP criteria

Conclusions:

The acute dermal toxicity test showed an LD50 > 5000 mg/kg bw

Executive summary:

In a pre-GLP acute toxicity study similar to OECD 402, 10 rabbits were dermally exposed to 5000 mg/kg bw test substance. All animals survived the 14 -day observation period. Under the conditions of the test the dermal LD50 was determined to be >5000 mg/kg bw in rabbits.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

The study is considered to be a reliability 2 study since it predates GLP but is similar to OECD TG 402.

Additional information

Acute oral toxicity:

In a pre-GLP acute toxicity study similar to OECD 401, 10 rats were orally exposed to 5000 mg/kg bw test substance. All animals survived the 14 -day observation period. Under the conditions of the test the acute oral LD50 was determined to be >5000 mg/kg bw in rats.

Acute dermal toxicity:

In a pre-GLP acute toxicity study similar to OECD 402, 10 rabbits were dermally exposed to 5000 mg/kg bw test substance. All animals survived the 14 -day observation period. Under the conditions of the test the dermal LD50 was determined to be >5000 mg/kg bw in rabbits.

Acute inhalation toxicity:

The acute inhalation toxicity for the substance can be derived using data on the acute oral toxicity using the following methodology:CLP guidance (2015 3.1.6.1.8. Example 8, page 268):using the extrapolation formula 1 mg/kg bw = 0.0052 mg/l/4h. 

The LD50 of the substance for acute oral toxicity is > 5000 mg/kg bw. This 5000 mg/kg bw can be converted to > 26 mg/l = 26 gram/m3. Taking into account the inhalation absorption as 100% and oral absorption 50%, the acute inhalation toxicity would become =>13000 mg/kg bw.

The saturated vapour pressure of the substance is: 48.5 mg/m3 (MW*VapPres/ (8.3*293). This means that the acute inhalation LC50 > 13000 mg/m3 cannot be reached because it exceeds the saturated vapour pressure by more than a factor of 200 (268).

Justification for classification or non-classification

Based on the experimental results of the acute oral and dermal toxicity tests and the derived value for inhalation toxicity the substance does not have to be classified for acute toxicity in accordance with CLP, Regulation (EC) No. 1272/2008 and its amendments.