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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
repeated dose toxicity
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
repeated dose toxicity
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - workers

Acute / short-term exposure - systemic effects

 

In acute toxicity studies, octahydro-4,7-methano-1H-indenedimethanol (TCD-Alcohol DM) has been shown to be of low toxicity.

LD50 oral: 2250 mg/kg bw (Hollander/Hoechst AG, 1975)

LD50 dermal: > 10,000 mg/kg bw (Collier/Safepharm, 1981)

Data on toxic effects by inhalation exposure have not been identified. Based on the low vapour pressure of TCD-Alcohol DM it is estimated that the saturated vapour concentration will be too low to cause acute toxic effects (see Sect. 7.2.2).

From studies available, reliable short-term dose response relations cannot be deduced. Acute toxicity data do not provide sufficient information on sublethal toxic effects to gather NOAELs as starting points. DNELs cannot be derived.

In accordance with ECHA Guidance on information requirements and chemical safety assessment - Chapter R.8, DN(M)EL need not be derived in case of low acute toxicity. Long-term DNELs are derived (see below), and these would be protective against short-term exposures.

 

Acute / short-term exposure - local effects

 

TCD-Alcohol DM is not irritating to the skin. However, it is irritating to eyes (Category 2). Data on inhalation exposure could not be located. From the data available, reliable dose descriptors cannot be obtained. A DNEL cannot be derived as there are no suitable starting points. For eye irritaing effects a qualitative risk assessment will be performed.

 

Long-term exposure - systemic effects

 

For TCD-Alcohol DM, initially only a screening study was available (OCED TG 422 combined repeated dose toxicity / reproduction/developmental toxicity screening test; NOTOX, 2010). No adverse effects were observed up to the highest dose tested (NOAEL of 600 mg/kg bw/day). Former DNELs were derived on basis of this study.

 

To date, results of the proposed tests are available as follows:

Repeated dose toxicity: NOAEL 1000 mg/kg bw/day in a OECD TG 408 study using rats (90-day, oral gavage; Huntingdon, 2013)

Developmental toxicity: NOAEL 1000 mg/kg bw/day in an OECD TG 414 (rats, oral gavage; Huntingdon, 2013). The NOEL of 500 mg/kg bw and day for maternal toxicity was based on statistically significantly decreases of food intake and bodyweight. This high dose effect was small and attributable to bad taste rather than toxicity and, therefore, it was not considered to be an advere effect.

Due to the finding that no adverse effects were observed in all three tests up to the highest dose tested (i.e. up to the limit dose of the 90 -day toxicity and developmental toxicity study) no hazard after repeated exposure to the substance could be identified and therefore, no DNEL values were derived.

 

Long-term exposure - local effects

 The skin irritating potential of TCD-Alcohol DM is low as demonstrated in an acute skin irritation test. Dose descriptors for long term exposure local effects are not available, hence no DNEL for long-term-exposure local effects is derived. No local effects were seen in the 28 -day screening study or in the 90 -day study. Local effects in the developmental study were attributed to reflux, but not to TCD alcohol DM itself.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
repeated dose toxicity
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
repeated dose toxicity
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
repeated dose toxicity
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - General Population

Acute / short-term exposure - systemic effects

 

In acute toxicity studies, octahydro-4,7-methano-1H-indenedimethanol (TCD-Alcohol DM) has been shown to be of low toxicity.

LD50 oral: 2250 mg/kg bw (Hollander/Hoechst AG, 1975)

LD50 dermal: > 10,000 mg/kg bw (Collier/Safepharm, 1981)

Data on toxic effects by inhalation exposure have not been identified. Based on the low vapour pressure,it is estimated that the saturated vapour concentration will be too low to cause acute toxic effects (see Sect. 7.2.2).

From studies available, reliable short-term dose response relations cannot be deduced. Acute toxicity data do not provide sufficient information on sublethal toxic effects to gather NOAELs as starting points. DNELs cannot be derived.

In accordance with ECHA Guidance on information requirements and chemical safety assessment - Chapter R.8, DN(M)EL need not be derived in case of low acute toxicity. Long-term DNELs are derived (see below), and these would be protective against short-term exposures.

 

Acute / short-term exposure - local effects

 

TCD-Alcohol DM is not irritating to skin. However it is irritating to eyes (Category 2). Data on inhalation exposure could not be located.

From the data available, reliable dose descriptors cannot be obtained. A DNEL cannot be derived as there are no suitable starting points. For eye irritaing effects a qualitative risk assessment will be performed.

 

Long-term exposure - systemic effects

For TCD-Alcohol DM, one study regarding repeated doses toxicity was initially available (OCED TG 422 combined repeated dose toxicity / reproduction/developmental toxicity screening test; NOTOX, 2010). No adverse effects were observed up to the highest dose tested (NOAEL of 600 mg/kg bw/day). Former DNELs were derived on basis of this study.

 

To date, results of the proposed tests are available as follows:

Repeated dose toxicity: NOAEL 1000 mg/kg bw/day in a OECD TG 408 study using rats (90-day, oral gavage; Huntingdon, 2013)

Developmental toxicity: NOAEL 1000 mg/kg bw/day in an OECD TG 414 (rats, oral gavage; Huntingdon, 2013). The NOEL of 500 mg/kg bw and day for maternal toxicity was based on statistically significantly decreases of food intake and bodyweight. This high dose effect was small and attributable to bad taste rather than toxicity and, therefore, it was not considered to be an advere effect.

Due to the finding that no adverse effects were observed in all three tests up to the highest dose tested (i.e. up to the limit dose of the 90 -day toxicity and developmental toxicity study) no hazard after repeated exposure to the substance could be identified and therefore, no DNEL values were derived.

 

 

Long-term exposure - local effects

In the repeated dose studies including the 90-day repeated dose toxicity study, no local effects were observed that were clearly attributable to the test substance up to the highest dose tested (1000 mg/kg bw/day).The skin irritating potential of TCD-Alcohol DM is low as demonstrated in an acute skin irritation test. Dose descriptors for long term exposure local effects are not available, hence no DNEL for long-term-exposure local effects is derived.