Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
49 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
18
Modified dose descriptor starting point:
NOAEC
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:
13.9 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
72
Modified dose descriptor starting point:
NOAEL
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

Table 1: Critical Preliminary DNEL Values for isobutyric acid, monoester with 2,2,4 -trimethylpentane-1,3 -diol

 

Exposure Pattern

DNEL

Workers

General Population

Acute – inhalation, systemic

not calculated1

not calculated

Acute – inhalation, local

not calculated

not calculated

Acute – dermal, systemic

not calculated

not calculated

Acute – dermal, local

not calculated2

not calculated

Acute – oral, systemic

not relevant3

not relevant3

Long-term – inhalation, systemic

49.0 mg/m3

14.5 mg/m3

Long-term – inhalation, local

not relevant4

not relevant4

Long-term – dermal, systemic

13.9 mg/kg/day

8.33 mg/kg/day

Long-term – dermal, local

No data

No data

Long-term – oral, systemic

not relevant3

8.33 mg/kg/day

1 Chapter 8 of the REACH TGD (Appendix R.8-8) indicates that acute exposure DNEL values are not normally required. Additionally, the lack of acute oral or dermal toxicity would indicate isobutyric acid, monoester with 2,2,4 -trimethylpentane-1,3 -diol is non-hazardous under acute exposure scenarios.

2 Assessment based on a lack of significant skin irritation.

3 It is assumed that there will be no acute or long-term oral exposures to isobutyric acid, monoester with 2,2,4 -trimethylpentane-1,3 -diol in worker populations or acute oral exposures in consumer populations.

4 Eye and respiratory irritation thresholds are assumed to exceed thresholds for chronic systemic effects.

 

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
14.5 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
30
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:
8.33 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
120
Modified dose descriptor starting point:
NOAEL
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:
8.33 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
120
Modified dose descriptor starting point:
NOAEL
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

Table 1: Critical Preliminary DNEL Values for isobutyric acid, monoester with 2,2,4 -trimethylpentane-1,3 -diol

 

Exposure Pattern

DNEL

Workers

General Population

Acute – inhalation, systemic

not calculated1

not calculated

Acute – inhalation, local

not calculated

not calculated

Acute – dermal, systemic

not calculated

not calculated

Acute – dermal, local

not calculated2

not calculated

Acute – oral, systemic

not relevant3

not relevant3

Long-term – inhalation, systemic

49.0 mg/m3

14.5 mg/m3

Long-term – inhalation, local

not relevant4

not relevant4

Long-term – dermal, systemic

13.9 mg/kg/day

8.33 mg/kg/day

Long-term – dermal, local

No data

No data

Long-term – oral, systemic

not relevant3

8.33 mg/kg/day

1 Chapter 8 of the REACH TGD (Appendix R.8-8) indicates that acute exposure DNEL values are not normally required. Additionally, the lack of acute oral or dermal toxicity would indicate isobutyric acid, monoester with 2,2,4 -trimethylpentane-1,3 -diol is non-hazardous under acute exposure scenarios.

2 Assessment based on a lack of significant skin irritation.

3 It is assumed that there will be no acute or long-term oral exposures to isobutyric acid, monoester with 2,2,4 -trimethylpentane-1,3 -diol in worker populations or acute oral exposures in consumer populations.

4 Eye and respiratory irritation thresholds are assumed to exceed thresholds for chronic systemic effects.