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EC number: 203-854-4 | CAS number: 111-29-5
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 35 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 10
- 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:
- 10 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 40
- 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
Only the DNEL for long-term systemic effects are derived since 1,5-pentanediol is non-irritating and acutely practically non-toxic.
In an OECD 422 study, male and female Wistar rats received 1,5-pentanediol at doses of 100, 300 or 1000 mg/kg/day by oral gavage administration. Males were treated daily for two weeks before pairing and up to necropsy (after a minimum of five consecutive weeks). Females were treated daily for two weeks before pairing, throughout pairing, gestation and until Day 13 of lactation. There was no adverse effect on body weight gain and there were no treatment-related findings at the hematological or biochemical examination of the blood. At the end of the treatment period, there were no treatment-related macroscopic or microscopic findings and there were no changes to organ weights. The no-observed-adverse-effect level (NOAEL) for systemic toxicity was therefore considered to be 1000 mg/kg/day.
Based on a weight of evidence approach, subchronic toxicity data from the structural analogue 1,6-hexanediol (CAS No. 629-11-8) were taken into account for derivation of DNELs.
The DNELs for long-term exposure are derived from the no observed effect level in a 90–day repeated dose toxicity study performed according OECD guideline 408 (BASF SE, 2014). The only effect that has been noted in high-dose males (1000 mg/kg/d) were decreases in body weights. Since no treatment-related effects of toxicological relevance have been observed at 400 mg/kg/d in neither males nor females, this dose is used as starting point for DNEL derivation.
Inhalation:
In general, the calculation of DNEL is based on the observed effect level which has to be modified.
To correct the interspecies difference between rat and human the NOAEL (400 mg/kg/d) has to be corrected by the risk assessors 0.38 mg/m3and 6.7 m3/10 m3regarding breathing volume (rat, 8h) and frequency (worker at rest vs. at light activity), respectively. Furthermore, an additional factor of 2 has to be included considering 50% absorption following oral up-take and 100% following inhalation.
Corrected NOAEC = NOAEL / 0.38 mg/m3x (6.7/10) / 2 = 352,6 mg/m3.
Furthermore, according to ECHA guidance document R8 and ECETOC Technical Report no. 110, the following assessment factors have to be taken into account:
- intraspecies differences: 5
- exposure duration: 2
- Quality of database: 1
The DNEL is calculated according to the formula DNEL = (corrected starting point)/(overall AF) as stated in R8 (ECHA, May 2008). Thus, the resulting DNEL for systemic long-term inhalative effects of 1,5-pentanediol is 35.26 mg/m3 for workers.
Dermal DNEL
For the DNEL of systemic dermal effects a correction of the starting point is not required, since the observed effect level was derived in an oral 90–day repeated dose toxicity study (BASF SE, 2014). Same absorption following oral and dermal exposure are assumed.
According to ECHA guidance R8 and ECETOC Technical Report no. 110, the following assessment factors were taken into account for the final DNEL calculation:
- interspecies differences: 4
- intraspecies differences: 5
- exposure duration: 2
-Quality of database: 1
Based on these assessment factors, the DNEL for systemic long-term dermal effects of 1,5-pentanediol is 400 mg/kg/d / 40 = 10 mg/kg bw/d for workers.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 8 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 20
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:
- 5 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 80
- 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:
- 5 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 80
- 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
Only the DNEL for long-term systemic effects are derived since 1,5-pentanediol is non-irritating and acutely practically non-toxic. Hence, no short-term DNELs need to be derived.
In an OECD 422 study, male and female Wistar rats received 1,5-pentanediol at doses of 100, 300 or 1000 mg/kg/day by oral gavage administration. Males were treated daily for two weeks before pairing and up to necropsy (after a minimum of five consecutive weeks). Females were treated daily for two weeks before pairing, throughout pairing, gestation and until Day 13 of lactation. There was no adverse effect on body weight gain and there were no treatment-related findings at the hematological or biochemical examination of the blood. At the end of the treatment period, there were no treatment-related macroscopic or microscopic findings and there were no changes to organ weights. The no-observed-adverse-effect level (NOAEL) for systemic toxicity was therefore considered to be 1000 mg/kg/day.
Based on a weight of evidence approach, subchronic toxicity data from the structural analogue 1,6-hexanediol (CAS No. 629-11-8) were taken into account for derivation of DNELs.
The DNELs for long-term exposure are derived from the no observed effect level in a 90–day repeated dose toxicity study performed according OECD guideline 408 (BASF SE, 2014). The only effect that has been noted in high-dose males (1000 mg/kg/d) were decreases in body weights. Since no treatment-related effects of toxicological relevance have been observed at 400 mg/kg/d in neither males nor females, this dose is used as starting point for DNEL derivation.
Inhalation
For the DNEL of systemic inhalative effects a correction of the starting point is required, since the observed effect level was derived from an oral 90–day repeated dose toxicity study (BASF, 2014).
To correct the interspecies difference between rat and human the observed effect level has to be corrected by the risk assessors 1.15 m3regarding breathing volume and frequency (rats, 24h). Furthermore, since no experimental data is available, as a worst case approach an oral absorption of 50% and absorption following inhalation of 100% is assumed. Thus, the corrected starting point for the general population is 400 / 1.15 mg/m3 /2 = 173.9 mg/m3/d for inhalation. Subsequently the following assessment factors have to be taken into account for the final DNEL calculation:
- intraspecies differences: 10
- exposure duration: 2.
- Quality of database: 1
The DNEL is calculated according to the formula DNEL = (corrected starting point)/(overall AF) as stated in R8 (ECHA, May 2008). Thus, the resulting DNEL for systemic long-term inhalative effects of 1,5-pentanediol is 8.7 mg/m3 for the general population.
Oral and Dermal
For the DNEL of systemic oral and dermal effects a correction of the starting point is not required, since the observed effect level was derived in a 90–day repeated dose toxicity study (BASF SE, 2014).
For the DNEL of systemic oral and dermal effects a correction of the starting point is not required, since the observed effect level was derived in a 90–day repeated dose toxicity study (BASF SE, 2014) and the same absorption is assumed following oral and dermal up-take. The following assessment factors were taken into account for the final DNEL calculation:
- interspecies differences 4
- intraspecies differences 10
- exposure duration: 2
- Quality of database: 1.
The resulting DNEL for systemic long-term oral and dermal effects of 1,5-pentanediol is therefore 5 mg/kg bw/d for the general population.
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