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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
DNEL (Derived No Effect Level)
Value:
12 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
150
Dose descriptor starting point:
NOAEC
Value:
1 800 mg/m³
Modified dose descriptor starting point:
NOAEC
Value:
900 mg/m³
Explanation for the modification of the dose descriptor starting point:

Description: Relevant dose-descriptor inhalation

Value: NOAEL: 1800 mg/m3

Remark: This is the concentration where no adverse effects were seen in an extended repeated dose inhalation study.

 

Description: Modification of starting point for exposure time (inhalation)

Value: 2

Remark: Workers are assumed to have 8 hours of exposure 6/8 hours.

 

Description: Modification of starting point for differences in respiratory volumes

Value: factored into the value 2 above

Remark: Respiratory rate is higher (6.7/10 m3) for worker doing light activity relative to the resting state for the rats in the study.

AF for dose response relationship:
1
Justification:
The robust database supports the confidence in the dose descriptor.
AF for differences in duration of exposure:
6
Justification:
Appropriate AF for 2-week inhalation study to chronic exposure. Value adopted per REACH guidance R.8.4.3.1.
AF for interspecies differences (allometric scaling):
2.5
Justification:
A default factor of 2.5 is appropriate per REACH guidance R.8.4.3.1 for inhalation.
AF for intraspecies differences:
5
Justification:
This is a default assessment factor for the general population per REACH Guidance R.8.4.3.1 for inhalation.
AF for the quality of the whole database:
1
Justification:
A high quality, robust toxicity database exists for this substance.
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
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:
DNEL (Derived No Effect Level)
Value:
200 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
5
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

This is a dose derived from the concentration where no adverse effects were seen in an extended oral study.

AF for dose response relationship:
1
Justification:
The robust database supports the confidence in the dose descriptor.
AF for differences in duration of exposure:
2
Justification:
A value of 2 was assigned for dermal based on oral subchronic (assumes 100% absorption dermally).
AF for interspecies differences (allometric scaling):
1
Justification:
A value of 1.0 was assigned for dermal because of low skin penetration potential and no differences in effect between rat and human, and mechanism and kinetics do not apply.
AF for intraspecies differences:
2.5
Justification:
A value of 2.5 was assigned for dermal because halving the default value is still conservative based on low variability among humans in skin patch test.
AF for the quality of the whole database:
1
Justification:
A high quality, robust toxicity database exists for this substance.
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

This is a colourless and odourless liquid and exposure is most likely via the dermal route for workers but can conceivably occur by the inhalation route if aerosolization occurs. Therefore, DNELs for the dermal and inhalation routes of exposure have been determined but not for the oral route of exposure.

No local effects are expected from any route of exposure and no DNELs were derived for local effects.

This substance is not classified for acute or repeated exposure toxicity.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
600
Dose descriptor starting point:
NOAEC
Value:
1 800 mg/m³
Modified dose descriptor starting point:
NOAEC
Value:
450 mg/m³
Explanation for the modification of the dose descriptor starting point:

Description: Relevant dose-descriptor inhalation

Value: NOAEL: 1800 mg/m3

Remark: This is the concentration where no adverse effects were seen in an extended repeated dose inhalation study.

 

Description: Modification of starting point for exposure time (inhalation)

Value: 4 general population (inhalation)

Remark: Exposure in the animal study was for 6 hours/day while the general population is assumed to be exposed as long as 24 hours/day (6/24 = 0.25 or an AF=4).

 

Description: Modification of starting point for differences in respiratory volumes (inhalation)

Value: 1

Remark: Respiratory rate is resting for rats on study and general population.

AF for dose response relationship:
1
Justification:
The robust database supports the confidence in the dose descriptor.
AF for differences in duration of exposure:
6
Justification:
Appropriate AF for 2-week inhalation study to chronic exposure.
AF for other interspecies differences:
2.5
Justification:
A default factor of 2.5 is appropriate per REACH guidance R.8.4.3.1.
AF for intraspecies differences:
10
Justification:
This is a default assessment factor for the general population per REACH Guidance R.8.4.3.1.
AF for the quality of the whole database:
1
Justification:
A high quality, robust toxicity database exists for this substance.
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
100 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
10
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Description: Relevant dose-descriptor dermal

Value: NOAEL: 1000 mg/kg-bw/day

Remark: This is a dose derived from the concentration where no adverse effects were seen in an extended oral study.

AF for dose response relationship:
1
Justification:
The robust database supports the confidence in the dose descriptor.
AF for differences in duration of exposure:
2
Justification:
Value adopted per REACH guidance R.8.4.3.1 the dermal default factor applies to an extrapolation from 90-day oral toxicity study to chronic no effect level.
AF for interspecies differences (allometric scaling):
1
Justification:
Effect by this route is not dependent on metabolic rate.
AF for other interspecies differences:
1
Justification:
For dermal exposure, no differences in susceptibility between rat and human were observed in dermal studies.
AF for intraspecies differences:
5
Justification:
This is a default assessment factor for the general population per REACH Guidance R.8.4.3.1. Human repair-insult patch test results suggest no systemic toxic absorption and intraspecies variability for up to 75% of the substance by this route of exposure; reducing the default assessment factor by half is still conservative.
AF for the quality of the whole database:
1
Justification:
A high quality, robust toxicity database exists for this substance.
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
5 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
200
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Description: Relevant dose-descriptor oral

Value: NOAEL: 1000 mg/kg-bw/day

Remark: This is a dose derived from the concentration where no adverse effects were seen in an extended oral study.

AF for dose response relationship:
1
Justification:
The robust database supports the confidence in the dose descriptor.
AF for differences in duration of exposure:
2
Justification:
Value adopted per REACH guidance R.8.4.3.1 the oral and dermal default factor applies to an extrapolation from 90-day oral toxicity study to chronic no effect level.
AF for interspecies differences (allometric scaling):
4
Justification:
Scaling factor for oral based on differences in default metabolic rates.
AF for other interspecies differences:
2.5
Justification:
A default factor of 2.5 is appropriate per REACH guidance R.8.4.3.1.
AF for intraspecies differences:
10
Justification:
This is a default assessment factor for the general population per REACH Guidance R.8.4.3.1.
AF for the quality of the whole database:
1
Justification:
A high quality, robust toxicity database exists for this substance.
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

This is a colourless and odourless liquid intended for many different endpoint uses including personal care products and cosmetics, and exposure may occur by the oral, dermal, and inhalation routes of exposure for the general population. Therefore, DNELs for all three routes of exposure have been derived for the general population

No local effects are expected from any route of exposure and no DNELs were derived for local effects.

This substance is not classified for acute or repeated exposure toxicity.