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EC number: 226-285-3 | CAS number: 5343-92-0
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 17.6 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 17
- Modified dose descriptor starting point:
- NOAEC
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 35.2 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 8.5
- Modified dose descriptor starting point:
- NOAEC
Local effects
Long term exposure
- Hazard assessment conclusion:
- other toxicological threshold
Acute/short term exposure
- Hazard assessment conclusion:
- other toxicological threshold
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 25 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:
- DNEL (Derived No Effect Level)
- Value:
- 25 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 40
- Modified dose descriptor starting point:
- NOAEL
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.02 mg/cm²
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 5
- Dose descriptor:
- other: NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.02 mg/cm²
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 5
- Dose descriptor starting point:
- other: NOAEL
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
1,2 pentanediol was tested in an oral repeated dose toxicity study according to OECD 408. Furthermore, there are additional information available for the structural closely related substances 1,2 butandiol (CAS 584-03-2) and 1,2 hexanediol (CAS 6920 -22 -5):
In an oral repeated dose toxicity study according to OECD 408, 1,2-Pentanediol was administered by gavage to groups of 10 male and 10 female Wistar rats at dose levels of 0 mg/kg bw, 50 mg/kg bw/d, 250 mg/kg bw/d and 1000 mg/kg bw/d over a period of 3 months. The expsoure did not cause test substance-related adverse signs of systemic toxicity. Therefore, the no observed adverse effect level (NOAEL) was 1000 mg/kg bw/d in male and in female Wistar rats.
1,2 butanediol (CAS 584-03-2) was tested in an OECD Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test (OECD Guideline 422; ) in accordance with GLP. 10 rats/sex (Crj:CD (SD)) were administered 0, 40, 200 and 1000 mg/kg bw/day 1,2 butanediol in distilled water by gavage. Due to the test procedure the administration was 42 days for the males and 37 days for the females (day 14 before mating to day 3 of lactation).
There were no death throughout the observation period of 42 days. Body weight, food consumption, hematology parameters, clinical chemistry parameters, organ weight, or pathological examination between the treated and control animals did not show any visible differences. Transient hypolocomotion and hypopnea at the 1000 mg/kg was observed in females. This effect was not considered to be systemically adverse as it is of transient nature. Therefore, the systemic repeated dose NOAEL of 1,2 butane diol is 1000 mg/kg/day for male and female rats.
The NOEL (300 mg/kg bw) of the developmental toxicity study conducted with 1,2 -hexanediol (read across) was used as starting point for DNEL derivation (most conservative approach).
A dose of 0, 350, 700 and 1000 mg/kg 1,2 hexanediol was applied onto the shaved skin of 10 ten Srague Dawley rats per sex and dose in a 90 day dermal toxicity study according to OECD 411 and GLP. The study was including additional mal rat fertility parameters (sperm count and sperm motility and morphology examination) and FOB.
Daily dermal administration was associated with slight dermal irritation at 1000 mg/kg/day. Treated skin changes included a low incidence of slight focal erythema/demal thickening observed at necropsy and minimal epidermal hyperplasia and hyperkeratosis observed microscopically. The microscopic changes observed would not be expected to progress to ulceration or chronic skin damage. No systemic effects that can be attributed to dermal 1,2 hexanediol exposure were observed. The systemic dermal NOAEL of this 90 day study is >1000 mg/kg. The local dermal NOAEL is 700 mg/kg/day due to the local effects described above.
Short-term DNEL systemic
LD 50 oral > 5000 mg/kg
LD50 demal > 2000 mg/kg
LC 50 inhal. > 7.015 mg/L (aerosol)
No relevant acute systemic hazard is expected. Some effects at the highest test concentration are described but no NOEC or NOEL is known. DNEL is not quantifiable from acute toxicity studies, therefore no DNEL derivation was done. Repeated dose DNEL protects against acute effects as well. A short term inhalative exposure as twice as high as the longterm DNEL can be regarded as safe.
Short-term DNEL local
Non irritating to the skin but possible risk of servere damage to the eye. Effect is not quantifiable. As a consequence no DNEL is derived. Risk minimization measurements have to be applied. Concentration limits of EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 may be used for rough estimation base on general experience.
Long-term DNEL systemic
Inhalation worker
Not the relevant route of exposure due to the low vapour pressure.
Description |
Value |
Remark |
Step 1) Relevant dose-descriptor |
NOAELrat 300 mg/kg bw |
NOEL developmental tox study |
Step 2) modification of the starting point |
|
|
|
1/0.38 |
route to route (8h exposure) |
|
1/1 |
absorption oral ~ inhal. (see toxicokinetic) |
|
10 m³/6.7 m³ |
to light work |
Step 2) Assessment factors |
|
|
Exposure duration |
6 |
Sub acute to chronic |
Interspecies |
1 |
Not necessary for inhalation |
Intraspecies |
5 |
worker |
Quality of database |
1 |
|
DNEL |
Value |
|
For workers (systemic) |
300/ (0.38 x 1 x 1.5) (6 x 1 x 5 x 1) =17.6 mg/m³
|
|
Dermal worker long term (local)
Description |
Value |
Remark |
Step 1) Relevant dose-descriptor |
NOAEL loc. = 10.9 mg/cm²/day |
Dermal local NOAELrat OECD 411 NOAELrat, local = 700 mg/kg bw area ~16 cm² rat ~250 g: |
Step 2) Assessment factors |
|
|
Exposure duration |
1 |
no time extrapolation as NOAEL (no accumulation of a non-effect) |
Interspecies |
1 |
Extrapolation local effects rat to human |
Intraspecies |
5 |
worker |
Quality of database |
1 |
|
DNEL |
Value |
|
For workers (local) |
10.9 mg/cm²/day / 5 = 2.02 mg/cm² |
|
Dermal worker long term (systemic)
Description |
Value |
Remark |
Step 1) Relevant dose-descriptor |
NOAELrat 1000 mg/kg bw |
Dermal NOAELrat OECD 411
|
Step 2) Assessment factors |
|
|
Exposure duration |
2 |
Sub chronic to chronic |
Interspecies |
4 |
Extrapolation rat to human |
Intraspecies |
5 |
worker |
Quality of database |
1 |
|
DNEL |
Value |
|
For workers (systemic) |
1000 mg/kg/day / (2 x 4 x 5 x 1) =25 mg/kg bw. |
|
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 4.4 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 68
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 8.8 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 34
- Modified dose descriptor starting point:
- NOAEC
Local effects
Long term exposure
- Hazard assessment conclusion:
- other toxicological threshold
Acute/short term exposure
- Hazard assessment conclusion:
- other toxicological threshold
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 12.5 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:
- DNEL (Derived No Effect Level)
- Value:
- 12.5 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 80
- Modified dose descriptor starting point:
- NOAEL
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.1 mg/cm²
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 10
- Dose descriptor:
- other: NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.1 mg/cm²
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 10
- Dose descriptor starting point:
- other: NOAEL
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.25 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 240
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.25 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 240
- Modified dose descriptor starting point:
- NOAEL
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - General Population
DNELs for consumers were derived based on the same studies as for workers. A short description of the essential studies can be found in the workers section directly above and not repeated here.
Short-term DNEL systemic
LD 50 oral > 5000 mg/kg
LD50 demal > 2000 mg/kg
LC 50 inhal. > 7.015 mg/L (aerosol)
No relevant acute systemic hazard is expected. Some effects at the highest test concentration are described but no NOEC or NOEL is known. DNEL is not quantifiable from acute toxicity studies, therefore no DNEL derivation was done. Repeated dose DNEL protects against acute effects as well. A short term inhalative exposure as twice as high as the longterm DNEL can be regarded as safe.
Short-term DNEL local
Non irritating to the skin but possible risk of servere damage to the eye. Effect is not quantifiable. As a consequence no DNEL is derived. Risk minimization measurements have to be applied. Concentration limits of EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 may be used for rough estimation base on general experience.
DNEL Consumer
Not the relevant route of exposure due to the low vapour pressure.
Long term DNEL inhalation
Description |
Value |
Remark |
|||
Step 1) Relevant dose-descriptor |
NOAELrat 300 mg/kg bw |
NOEL developmental tox. study |
|||
Step 2) modification of the starting point |
|
|
|||
|
1/1.15 |
route to route (8h exposure) |
|||
|
1/1 |
absorption oral to inhal. |
|||
Step 2) Assessment factors |
|
|
|||
Exposure duration |
6 |
Sub acute to chronic |
|||
Interspecies |
1 |
Not necessary for inhalation |
|||
Intraspecies |
10 |
consumer |
|||
Quality of database |
1 |
|
|||
DNEL |
Value |
||||
For consumer (systemic) |
300/ (1.15 x 1) (6 x 1 x 10 x 1) =4.4 mg/m³
|
||||
Dermal consumer long term (local)
Description |
Value |
Remark |
Step 1) Relevant dose-descriptor |
NOAEL local = 10.09 mg/cm² |
Dermal local NOAELrat OECD 411 NOAELrat, local 700 mg/kg bw rat ~ 250 g area ~ 16 cm² |
Step 2) Assessment factors |
|
|
Exposure duration |
1 |
no time extrapolation as NOAEL (no accumulation of a non-effect) |
Interspecies |
1 |
Extrapolation local effects rat to human |
Intraspecies |
10 |
consumer |
Quality of database |
1 |
|
DNEL |
Value |
|
For consumer (local) |
10.09 mg/cm² / 10 = 1.1 mg/cm² |
|
Dermal worker long term (systemic)
Description |
Value |
Remark |
Step 1) Relevant dose-descriptor |
NOAELrat 1000 mg/kg bw |
Dermal systemic NOAELrat OECD 411
|
Step 2) Assessment factors |
|
|
Exposure duration |
2 |
Sub chronic to chronic |
Interspecies |
4 |
Extrapolation local effects rat to human |
Intraspecies |
10 |
consumer |
Quality of database |
1 |
|
DNEL |
Value |
|
For workers (systemic) |
1000 mg/kg/day / (2 x 4 x 10 x 1) =12.5 mg/kg bw. |
|
Oral consumer long term (systemic)
Description |
Value |
Remark |
Step 1) Relevant dose-descriptor |
NOAELrat 300 mg/kg bw |
NOEL developmental tox. study |
Step 2) Assessment factors |
|
|
Exposure duration |
6 |
Sub acute to chronic |
Interspecies |
4 |
Interspecies extrapolation |
Intraspecies |
10 |
consumer |
Quality of database |
1 |
|
DNEL |
Value |
|
For consumer (systemic) |
300/ (6 x 4 x 10 x 1) = 1.25 mg/kg
|
|
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
