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REACH

3,4-dihydro-2,5,7,8-tetramethyl-2-(4,8,12-trimethyltridecyl)-2H-benzopyran-6-yl acetate

EC number: 231-710-0 | CAS number: 7695-91-2

Life Cycle description
Uses advised against

Toxicological information

Toxicological Summary

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure

Hazard assessment conclusion:: DNEL (Derived No Effect Level)
Value:: 73.5 mg/m³
Most sensitive endpoint:: repeated dose toxicity

DNEL related information

Overall assessment factor (AF):: 6
Modified dose descriptor starting point:: NOAEC

Acute/short term exposure

Hazard assessment conclusion:: no-threshold effect and/or no dose-response information available

DNEL related information

Local effects

Long term exposure

Hazard assessment conclusion:: no-threshold effect and/or no dose-response information available

Acute/short term exposure

Hazard assessment conclusion:: no-threshold effect and/or no dose-response information available

DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure

Hazard assessment conclusion:: DNEL (Derived No Effect Level)
Value:: 416.6 mg/kg bw/day
Most sensitive endpoint:: repeated dose toxicity

DNEL related information

Overall assessment factor (AF):: 24
Modified dose descriptor starting point:: NOAEL

Acute/short term exposure

Hazard assessment conclusion:: no-threshold effect and/or no dose-response information available

DNEL related information

Local effects

Long term exposure

Hazard assessment conclusion:: no-threshold effect and/or no dose-response information available

Acute/short term exposure

Hazard assessment conclusion:: no-threshold effect and/or no dose-response information available

Workers - Hazard for the eyes

Additional information - workers

DNEL acute

A DNEL_acuteshould be established for substances if an acute hazard toxicity (leading to C&L) has been identified and a potential for high peak exposures exists.

DL-Alpha-Tocopheryl acetate does not have to be labelled for acute toxicity and therefore, a derivation of a DNEL_acute is not necessary.

DNEL long-term systemic

DL-Alpha-Tocopheryl acetate is not classified for any toxicological endpoint. For the DNEL-derivation a NOAEL of 500 mg/kg bw was used derived from the 90-day repeated dose oral, based on hemorrhagic diathesis in males and females (an increase in APTT, PT and fibrinogen at 2000 mg/kg).

The dermal DNEL for long-term exposure - systemic effects for workers is derived as follows:

Description	Value	Remark
Step 1) Relevant dose-descriptor	NOAEL: 500 mg/kg bw/day	Based on hemorrhagic diathesis in males and females
Step 2) Modification of starting point	x100/5	100% for oral absorption, and 5% absorption is assumed for dermal absorption
Modified dose-descriptor	500 x 100/5 = 10000 mg/kg bw/day
Step 3) Assessment factors
Interspecies	4	Allometric scaling for the rat, the additional factor of 2.5 is omitted.
Intraspecies	3*	Default assessment factor
Exposure duration	2	A correction for duration from sub-chronic to chronic is required
Dose response	1
Quality of database	1
DNEL	Value
*DNEL using ECETOC AF	10000/ (4 x 3 x 2 x 1 x 1)= 416.6 mg/kg bw/day

The inhalation DNEL for long-term exposure - systemic effects for workers is derived as follows:

Description	Value	Remark
Step 1) Relevant dose-descriptor	NOAEL: 500 mg/kg bw/day	Based on hemorrhagic diathesis in males and females
Step 2) Modification of starting point	/0.38 m³/kg bw x 6.7 m³/10 m³ x50/100	8 h respiratory volume for rat. Correction for activity driven differences of respiratory volumes in workers compared to workers in rest. Default 50% for oral absorption, and 100% absorption is assumed for inhalation.
Modified dose-descriptor	500 x 0.67 x 0.5 / 0.38 = 440 mg/m³
Step 3) Assessment factors
Interspecies	1.0	No allometric scaling has to be applied in case of oral to inhalation route to route extrapolation. The additional factor of 2.5 is omitted.
Intraspecies	3*	Default assessment factor
Exposure duration	2	A correction for duration from sub-chronic to chronic is required
Dose response	1
Quality of database	1
DNEL	Value
*DNEL using ECETOC AF	440/ (1.0 x 3 x 2 x 1 x 1)= 73.5 mg/m³

General Population - Hazard via inhalation route

Systemic effects

Long term exposure

Hazard assessment conclusion:: DNEL (Derived No Effect Level)
Value:: 21.7 mg/m³
Most sensitive endpoint:: repeated dose toxicity

DNEL related information

Overall assessment factor (AF):: 10

Acute/short term exposure

Hazard assessment conclusion:: no-threshold effect and/or no dose-response information available

DNEL related information

Local effects

Long term exposure

Hazard assessment conclusion:: no-threshold effect and/or no dose-response information available

Acute/short term exposure

Hazard assessment conclusion:: no-threshold effect and/or no dose-response information available

DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure

Hazard assessment conclusion:: DNEL (Derived No Effect Level)
Value:: 250 mg/kg bw/day
Most sensitive endpoint:: repeated dose toxicity

DNEL related information

Overall assessment factor (AF):: 40
Modified dose descriptor starting point:: NOAEL

Acute/short term exposure

Hazard assessment conclusion:: no-threshold effect and/or no dose-response information available

DNEL related information

Local effects

Long term exposure

Hazard assessment conclusion:: no-threshold effect and/or no dose-response information available

Acute/short term exposure

Hazard assessment conclusion:: no-threshold effect and/or no dose-response information available

General Population - Hazard via oral route

Systemic effects

Long term exposure

Hazard assessment conclusion:: DNEL (Derived No Effect Level)
Value:: 12.5 mg/kg bw/day
Most sensitive endpoint:: repeated dose toxicity

DNEL related information

Overall assessment factor (AF):: 40
Modified dose descriptor starting point:: NOAEL

Acute/short term exposure

Hazard assessment conclusion:: no-threshold effect and/or no dose-response information available

DNEL related information

General Population - Hazard for the eyes

Additional information - General Population

DNEL acute

A DNEL_acuteshould be established for substances if an acute hazard toxicity (leading to C&L) has been identified and a potential for high peak exposures exists.

DL-Alpha-Tocopheryl acetate

does not have to be labelled for acute toxicity and therefore, a derivation of a DNEL_acuteis not necessary.

DNEL long-term systemic

Vitamin acetate (isomer) is not classified for any toxicological endpoint.

For the DNEL-derivation a NOAEL of 500 mg/kg bw was used derived from the 90-day repeated dose oral, based on hemorrhagic diathesis in males and females (an increase in APTT, PT and fibrinogen at 2000 mg/kg).

The dermal DNEL for long-term exposure - systemic effects for general population is derived as follows:

Description	Value	Remark
Step 1) Relevant dose-descriptor	NOAEL: 500 mg/kg bw/day	Based on hemorrhagic diathesis
Step 2) Modification of starting point	x100/5	100% for oral absorption and 5% absorption is assumed for dermal absorption.
Modified dose-descriptor	500 x 100/5 = 10000 mg/kg bw/day
Step 3) Assessment factors
Interspecies	4	Allometric scaling for the rat, the additional factor of 2.5 is omitted.
Intraspecies	5*	Default assessment factor
Exposure duration	2	A correction for duration from sub-chronic to chronic is required
Dose response	1
Quality of database	1
DNEL	Value
*DNEL using ECETOC AF	10000/ (4 x 5 x 2 x 1 x 1)= 250 mg/kg bw/day

The inhalation DNEL for long-term exposure - systemic effects for general population is derived as follows:

Description	Value	Remark
Step 1) Relevant dose-descriptor	NOAEL: 500 mg/kg bw/day	Based on hemorrhagic diathesis
Step 2) Modification of starting point	/ 1.15 m³/kg bw x 50/100	24 h respiratory volume for rats. 50% for oral absorption and 100% absorption is assumed for inhalation.
Modified dose-descriptor	500 / 1.15 x 0.5 = 217 mg/m³
Step 3) Assessment factors
Interspecies	1.0	No allometric scaling has to be applied in case of oral to inhalation route to route extrapolation. The additional factor of 2.5 is omitted.
Intraspecies	5*	Default assessment factor
Exposure duration	2	A correction for duration from sub-chronic to chronic is required.
Dose response	1
Quality of database	1
DNEL	Value
*DNEL using ECETOC AF	217/ (1.0 x 5 x 2 x 1 x 1)= 21.7 mg/m³

The oral DNEL for long-term exposure - systemic effects for general public is derived as follows:

Description	Value	Remark
Step 1) Relevant dose-descriptor	NOAEL: 500 mg/kg bw/day	Based on hemorrhagic diathesis
Step 2) Modification of starting point	Not required

Step 3) Assessment factors
Interspecies	4	Allometric scaling for the rat, the additional factor of 2.5 is omitted.
Intraspecies	5*	Default assessment factor
Exposure duration	2	A correction for duration from sub-chronic to chronic is required
Dose response	1
Quality of database	1
DNEL	Value
*DNEL using ECETOC AF	500/ (4 x 5 x 2 x 1 x 1)= 12.5 mg/kg bw/day

Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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