Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

Workers - Hazard via dermal route

Systemic effects

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

No modification of the dose descriptor is applied. In the absence of toxicokinetics data, the dermal absorption is considered to be 100% and therefore the NOAEL dermal is assumed to be equivalent to the NOAEL oral.

AF for dose response relationship:
1
Justification:
NOAEL as starting point
AF for differences in duration of exposure:
1
Justification:
No correction is applied for the duration of exposure since the animals were exposed thoughout the gestation period which would be also the case for women in contact with the substance in the worse case situation.
AF for interspecies differences (allometric scaling):
4
Justification:
Default value from rat to human
AF for other interspecies differences:
2.5
Justification:
Defaut value recommended by ECHA (guidance R8)
AF for intraspecies differences:
5
Justification:
Defaut value recommended by ECHA for worker (guidance R8)
AF for the quality of the whole database:
2
Justification:
Factor recommended by ECHA for Reproduction/Developmental Toxicity Screening Test to take account of the lower sensitivity of the study.
AF for remaining uncertainties:
1
Justification:
study fully compliant with OECD guideline and GLP
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)
Route of original study:
Dermal
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

The substance is classified as Category 1B skin sensitizer and thus falls in the moderate hazard band according to the Guidance on information requirements and chemical safety assessment (Part E). Handling of such substances should be well-controlled in order to avoid dermal contact and inhalation exposure.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

General Population - Hazard via dermal route

Systemic effects

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

No modification of the dose descriptor is applied. In the absence of toxicokinetics data, the dermal absorption is considered to be 100% and therefore the NOAEL dermal is assumed to be equivalent to the NOAEL oral.

AF for dose response relationship:
1
Justification:
NOAEL as starting point
AF for differences in duration of exposure:
1
Justification:
No correction is applied for the duration of exposure since the animals were exposed thoughout the gestation period which would be also the case for women in contact with the substance in the worse case situation.
AF for interspecies differences (allometric scaling):
4
Justification:
Default value from rat to human
AF for other interspecies differences:
2.5
Justification:
Defaut value recommended by ECHA (guidance R8)
AF for intraspecies differences:
10
Justification:
Defaut value recommended by ECHA for consumer (guidance R8)
AF for the quality of the whole database:
2
Justification:
Factor recommended by ECHA for Reproduction/Developmental Toxicity Screening Test to take account of the lower sensitivity of the study.
AF for remaining uncertainties:
1
Justification:
study fully compliant with OECD guideline and GLP
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)
Route of original study:
Dermal
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population