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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
3.53 mg/m³
Most sensitive endpoint:
effect on fertility
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
50
Modified dose descriptor starting point:
NOAEC
Value:
176.32 mg/m³
Explanation for the modification of the dose descriptor starting point:
Route-to-route extrapolation applies for non first-pass systemic effects; appropriate differences in kinetics and metabolism were considered.
AF for dose response relationship:
1
Justification:
ECHA default
AF for differences in duration of exposure:
2
Justification:
ECHA default (sub-chronic to chronic)
AF for interspecies differences (allometric scaling):
1
Justification:
ECHA default (allometric scaling AF considered in calculating corrected dose descriptor)
AF for other interspecies differences:
2.5
Justification:
ECHA default
AF for intraspecies differences:
5
Justification:
ECHA default (workers)
AF for the quality of the whole database:
1
Justification:
ECHA default
AF for remaining uncertainties:
2
Justification:
ECHA Default (adsorption factor of 2 for oral-inhalation conversion)
Acute/short term exposure
Hazard assessment conclusion:
high 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:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)
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:
effect on fertility
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Modified dose descriptor starting point:
NOAEL
Value:
100 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Route-to-route extrapolation applies for non first-pass systemic effects; appropriate differences in kinetics and metabolism were considered.
AF for dose response relationship:
1
Justification:
ECHA default
AF for differences in duration of exposure:
2
Justification:
ECHA default (sub-chronic to chronic)
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA default (oral to dermal scaling)
AF for other interspecies differences:
2.5
Justification:
ECHA default
AF for intraspecies differences:
5
Justification:
ECHA default (workers)
AF for the quality of the whole database:
1
Justification:
ECHA default
AF for remaining uncertainties:
1
Justification:
ECHA default
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)
DNEL related information

Local effects

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

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
high hazard (no threshold derived)

Additional information - workers

HCAT was not acutely toxic to the rat using the acute toxic class method, and no classification for acute toxicity was applied during hazard assessment. HCAT is, however, a category 1 skin sensitiser and category 1 eye irritant, two classifications which are non-threshold in nature as there are no dose-response data in order to derive a NOAEL. Therefore, all acute exposures must be managed by the implementation of qualitative risk management measures, defined in Section 11.

Generation of long-term toxicity data (repeated dose toxicity, toxicity to reproduction, developmental toxicity) on HCAT was waived in Sections 7.5 and 7.8, using exposure-based adaptation, and use of surrogate toxicity data in order to facilitate hazard assessment of HCAT. The surrogate toxicity data used for hazard assessment was on 2 -ethylhexanoic acid, where the representative NOAEL used came from repeated dose, reproductive and developmental toxicity studies (oral). These data were considered representative for the hazard assessment as 2 -ethylhexanoic acid is a significant impurity of HCAT and also the moiety that is considered to exhibit the most significant effect-bearing exposure to workers during the identified uses presented in Section 3.5. Further details can be found in Section 7.5.1 (repeated dose toxicity (oral), 7.8.1 (toxicity to reproduction) and 7.8.2 (developmental toxicity/teratogenicity).

Long-term local effects of HCAT to workers will also be controlled through application of the qualitative risk management measures implemented to control the acute effects of HCAT.

General Population - Hazard via inhalation route

Systemic effects

Acute/short term exposure
DNEL related information

Local effects

Acute/short term exposure
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Acute/short term exposure
DNEL related information

General Population - Hazard via oral route

Systemic effects

Acute/short term exposure
DNEL related information

General Population - Hazard for the eyes

Additional information - General Population

No hazard assessment for the general population was conducted as HCAT is not available to the general population.