Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 255-350-9 | CAS number: 41395-83-9
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
Oral (similar to OECD 401): LD50 rat, mouse > 5000 mg/kg bw
The hazard assessment is based on the data currently available. New studies with the registered substance and/or other member substances of the glycol esters category will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly.
For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the glycol esters category.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 13 Mar 1991 - 13 Mar 1991
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- No purity of test substance reported. Observation period only 7 days after treatment.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- adopted in 1987
- Deviations:
- yes
- Remarks:
- No purity of test substance reported. Observation period only 7 days after treatment
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 19 to 20 g - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 5.7 mL/kg
- Doses:
- 5000 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 7 days
- Frequency of weighing: on day of treatment and last day of observation
- Frequency of observations: once daily - Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Remarks:
- mouse
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred.
- Clinical signs:
- other: other: No abnormal clinical signs and no abnormal behaviour occured.
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- No purity of test substance reported.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- not applicable
- Principles of method if other than guideline:
- Study was conducted prior to adoption of any OECD guideline.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Fasting period before study: yes, 20-24 h
- Housing: 2-5 per cage - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- The test material was administered as supplied by the sponsor.
- Doses:
- Preliminary test: 1000, 5000, 10000 mg/kg bw
Main test: 10000, 15000, 20000 mg/kg bw - No. of animals per sex per dose:
- Preliminary test: 2 at 1000 mg/kg bw, 1 at 5000 and 1 at 10000 mg/kg bw
Main test: 5 - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Statistics:
- Probit method
- Preliminary study:
- 2m+2f animals at 1000 mg/kg: no mortality
1m+1f animal at 5000 mg/kg: no mortality
1m+1f animal at 10000 mg/kg: no mortality - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Remarks:
- rat
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Remarks:
- rat
- Effect level:
- 16 025 mg/kg bw
- Based on:
- test mat.
- Remarks:
- Calculated using Probit method
- 95% CL:
- > 12 973 - < 19 795
- Remarks on result:
- other:
- Remarks:
- 5 out of 10 animals were dead after 14d observation period after single oral dosing at 15000 mg/kg
- Mortality:
- 1 out of 10 rats was found dead after dosing at 10000 mg/kg. No mortality was seen in the preliminary study.
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.
Referenceopen allclose all
Dose |
Gender |
Total number of rats |
Number of dead rats after 14 day observation period |
% mortality |
1000 |
m |
2 |
0 |
0 |
1000 |
f |
2 |
0 |
0 |
5000 |
m |
1 |
0 |
0 |
5000 |
f |
1 |
0 |
0 |
10000 |
m |
1 |
0 |
0 |
10000 |
f |
1 |
0 |
0 |
10000 |
m |
5 |
1 |
10 |
10000 |
f |
5 |
0 |
0 |
15000 |
m |
5 |
4 |
80 |
15000 |
f |
5 |
1 |
20 |
20000 |
m |
5 |
4 |
80 |
20000 |
f |
4 |
2 |
50 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- > 5 000 mg/kg bw
- Quality of whole database:
- The available information comprises adequate and reliable studies (Klimisch score 2). The selected studies are sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The hazard assessment is based on the data currently available. New studies with the registered substance and/or other member substances of the glycol esters category will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly.
For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the glycol esters category.
Acute oral toxicity
The acute oral toxicity of Propylene dinonanoate (CAS 41395-83-9) was assessed in two studies conducted similar to OECD guideline 401. Single administration of 10, 15 and 20 g/kg bw to 5 rats per sex via oral gavage resulted in mortality of one animal at 10000 mg/kg bw (key study, 1977). The LD50 was calculated to be 16025 mg/kg bw in rats. Single administration of 5000 mg/kg bw to 5 female mice via oral gavage did not cause mortality (supporting study, 1991). No abnormal clinical signs and no abnormal behaviour occurred during the 7-day observation period.
Overall conclusion for acute toxicity
The available data indicate a very low level of acute toxicity following the oral route and thus Propylene dinonanoate (CAS 41395-83-9) is not considered to be hazardous following acute oral exposure.
Justification for classification or non-classification
CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.
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.