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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
0.9 mg/m³
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
225
Modified dose descriptor starting point:
NOAEC
Value:
194 mg/m³
Acute/short term exposure
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Acute/short term exposure
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.12 mg/kg bw/day
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
900
Modified dose descriptor starting point:
NOAEL
Value:
110 mg/kg bw/day
Acute/short term exposure
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

DNEL Long-term – dermal, systemic effects

Relevant dose descriptor for the endpoint concerned: NOAEL of 110 mg/kg bw/d in female rats in a Prenatal Developmental Toxicity Study (E.I. Dupont, 1980; Kennedy et al.,1987)

Assessment factors relating to the extrapolation procedure:

Interspecies: 4 (allometric scaling) and 2.5 (remaining differences)

Intraspecies: 5 (worker)

Time extrapolation: 6 (sub-acute to chronic study)

Route to route extrapolation: 1 (no correction necessary)

Dose-response: 1 (NOAEL)

Quality of whole database: 3 (sub-acute study, not all typical endpoints examined)

Overall assessment factor: 4 * 2.5 * 5 * 6 * 1 * 1 * 3 = 900

DNEL long-term– dermal, systemic effects: 110 mg/kg bw/d ÷ 900 = 0.12 mg/kg bw/d

DNEL Long-term–inhalation, systemic effects

Relevant dose descriptor for the endpoint concerned: NOAEL of 110 mg/kg bw/d in female rats in a Prenatal Developmental Toxicity Study (E.I. Dupont, 1980; Kennedy et al.,1987)

Correction of starting point:

Bioavailability: complete absorption is assumed (no correction necessary)

Route of exposure (dermal vs. inhalation exposure): complete absorption assumed (no correction necessary)

Differences in respiratory volumes: respiratory volume of the rat in 8 h corresponds to 0.38 m3/kg bw, additional correction for the higher standard respiratory volumes of workers compared to resting persons: correction factor = (1 ÷ 0.38) * (6.7 ÷ 10) = 1.76

Overall correction factor: 1.76

Corrected starting point: 110 * 1.76 = 194 mg/m3

Assessment factors relating to the extrapolation procedure:

Interspecies: 2.5 (remaining differences)

Intraspecies: 5 (worker)

Time extrapolation: 6 (sub-acute to chronic study)

Dose-response: 1 (NOAEL)

Quality of whole database: 3 (sub-acute study, not all typical endpoints examined)

Overall assessment factor: 2.5 * 5 * 6 * 1 * 3 = 225

DNEL Long-term–inhalation, systemic effects: 194 mg/m3 ÷ 225 = 0.9 mg/m3

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.2 mg/m³
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
450
Modified dose descriptor starting point:
NOAEC
Value:
96 mg/m³
Acute/short term exposure
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Acute/short term exposure
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.06 mg/kg bw/day
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
1 800
Modified dose descriptor starting point:
NOAEL
Value:
110 mg/kg bw/day
Acute/short term exposure
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.06 mg/kg bw/day
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
1 800
Modified dose descriptor starting point:
NOAEL
Value:
110 mg/kg bw/day
Acute/short term exposure
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

DNEL Long-term – dermal, systemic effects

Relevant dose descriptor for the endpoint concerned: NOAEL of 110 mg/kg bw/d in female rats in a Prenatal Developmental Toxicity Study (E.I. Dupont, 1980; Kennedy et al.,1987)

Assessment factors relating to the extrapolation procedure:

Interspecies: 4 (allometric scaling) and 2.5 (remaining differences)

Intraspecies: 10 (general population)

Time extrapolation: 6 (sub-acute to chronic study)

Route to route extrapolation: 1 (oral to dermal)

Dose-response: 1 (NOAEL)

Quality of whole database: 3 (sub-acute study, not all typical endpoints examined)

Overall assessment factor: 4 * 2.5 * 10 * 6 * 1 * 1 * 3 = 1800

DNEL long-term– dermal, systemic effects: 110 mg/kg bw/d ÷ 1800 = 0.06 mg/kg bw/d

DNEL Long-term–inhalation, systemic effects

Relevant dose descriptor for the endpoint concerned: NOAEL of 110 mg/kg bw/d in female rats in a Prenatal Developmental Toxicity Study (E.I. Dupont, 1980; Kennedy et al.,1987)

Correction of starting point:

Bioavailability: complete absorption is assumed (no correction necessary)

Route of exposure (dermal vs. inhalation exposure): complete absorption assumed (no correction necessary)

Differences in respiratory volumes: respiratory volume of the rat in 24 h corresponds to 1.15 m3/kg bw, correction factor 1 ÷ 1.15 = 0.87

Overall correction factor: 0.87

Corrected starting point: 110 * 0.87 = 96 mg/m3

Assessment factors relating to the extrapolation procedure:

Interspecies: 2.5 (remaining differences)

Intraspecies: 10 (general population)

Time extrapolation: 6 (sub-acute to chronic study)

Dose-response: 1 (NOAEL)

Quality of whole database: 3 (sub-acute study, not all typical endpoints examined)

Overall assessment factor: 2.5 * 10 * 6 * 1 * 3 = 450

DNEL Long-term–inhalation, systemic effects: 96 mg/m3 ÷ 450 = 0.2 mg/m3

DNEL Long-term - oral, systemic effects

Relevant dose descriptor for the endpoint concerned: NOAEL of 110 mg/kg bw/d in female rats in a Prenatal Developmental Toxicity Study (E.I. Dupont, 1980; Kennedy et al.,1987)

Correction of starting point:

Bioavailability: complete absorption is assumed (no correction necessary)

Route to route extrapolation: 1 (oral to dermal)

Assessment factors relating to the extrapolation procedure:

Interspecies: 4 (allometric scaling) and 2.5 (remaining differences)

Intraspecies: 10 (general population)

Time extrapolation: 6 (sub-acute to chronic study)

Dose-response: 1 (NOAEL)

Quality of whole database: 3 (sub-acute study, not all typical endpoints examined)

Overall assessment factor: 4 * 2.5 * 10 * 6 * 1 * 3 = 1800

DNEL long-term– dermal, systemic effects: 110 mg/kg bw/d ÷ 1800 = 0.06 mg/kg bw/d