Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
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EC number: - | CAS number: -
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.21 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 25
- Dose descriptor starting point:
- NOAEL
- Value:
- 32.8 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 30.3 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Repeated dose toxicity information is available from an oral sub-chronic toxicity study (100 days) (OECD 408 - Repeated Dose 90-day Oral Toxicity Study in combination with an OECD 443 EOGRT Study). For inhalation exposure, route-to-route extrapolation is applied. The dose descriptor starting point is converted into the modified dose descriptor starting point using the following equation (see Guidance IR&CSA Chapter R.8, Figure R. 8-3, p 21):
correctedinhalatory NOAEC
= oral NOAEL x 1 / 0.38 (m³ / kg / d) x (Absoral-rat/ Absinh-human) x 6.7 m³ (8h) / 10 m³ (8h)
= 34.4 x 1/0.38 x 0.5/1 x 6.7/10
= 30.3 mg/m³
- AF for differences in duration of exposure:
- 2
- Justification:
- sub-chronic (100 d) to chronic extrapolation
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- included in route to route extrapolation
- AF for other interspecies differences:
- 2.5
- Justification:
- default AF
- AF for intraspecies differences:
- 5
- Justification:
- default AF for workers
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- By inhalation
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- repeated dose toxicity
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- acute toxicity
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.87 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 300
- Dose descriptor starting point:
- NOAEL
- Value:
- 820 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 861 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The NOAEL (1000 mg/kg bw/day) originates from a 28-day Repeated Dose Dermal Toxicity Study (OECD TG 410) with the test (source) substance 'Oligomerisation and alkylation rection products of 2-phenylpropene and phenol' (OAPP). After adjustment to the target substance phenol, mono- & distyrenated (820 mg/kg bw/day), the dose descriptor staring point is corrected for differences in experimental and worker exposure conditions (dermal dose application for 7 days per week and 6 hours per day versus dermal worker exposure at only 5 days per week and 8 hours per day) resuling in a corrected/modified dose descriptor starting point: 820 mg/kg bw/day x 7/5 (days per week) x 6/8 (hours per day) = 861 mg/kg bw/day.
- AF for differences in duration of exposure:
- 6
- Justification:
- sub-acute (28 d) to chronic extrapolation
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat to human allometric scaling
- AF for other interspecies differences:
- 2.5
- Justification:
- default AF
- AF for intraspecies differences:
- 5
- Justification:
- default AF for workers
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- 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:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.299 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 50
- Dose descriptor starting point:
- NOAEL
- Value:
- 34.4 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 14.95 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Repeated dose toxicity information is available from an oral sub-chronic toxicity study (100 days) (OECD 408 - Repeated Dose 90-day Oral Toxicity Study in combination with an OECD 443 EOGRT Study). For inhalation exposure, route-to-route extrapolation is applied. The dose descriptor starting point is converted to the modified dose descriptor starting point using the following equation (see Guidance IR&CSA Chapter R.8, Figure R. 8-3, p 21):
correctedinhalatory NOAEC
= oral NOAEL x 1 / 1.15 (m³ / kg / d) x (Absoral-rat/ Absinh-human)
= 34.4 x 1 / 1.15 x 0.5 / 1
= 14.95 mg/m³
- AF for differences in duration of exposure:
- 2
- Justification:
- sub-chronic (100 d) to chronic extrapolation
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- included in route to route extrapolation
- AF for other interspecies differences:
- 2.5
- Justification:
- default AF
- AF for intraspecies differences:
- 10
- Justification:
- default AF for general population
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Dermal
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- repeated dose toxicity
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0 mg/kg bw/day
- 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:
- Dermal
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- skin irritation/corrosion
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.17 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:
- 34.4 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Repeated dose toxicity information is available from an oral sub-chronic toxicity study (100 days) (OECD 408 - Repeated Dose 90-day Oral Toxicity Study in combination with an OECD 443 EOGRT Study). Modification of the dose descriptor starting point is not required.
- AF for differences in duration of exposure:
- 2
- Justification:
- sub-chronic (100 d) to chronic extrapolation
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat-to-human allometric scaling
- AF for other interspecies differences:
- 2.5
- Justification:
- default AF
- AF for intraspecies differences:
- 10
- Justification:
- default AF for general population
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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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