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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
Skin irritation (OECD 404): not irritating
Skin, human (volunteer study, GCP): not irritating
Eye irritation(similar to OECD 405): not irritating
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
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 01 to 11 Mar 1991
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Purity of test substance not reported. No GLP statement. Limited reporting details.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted in 2015
- Deviations:
- yes
- Remarks:
- no rationale for in vivo testing, no initial testing with one animal
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted in 1981
- Deviations:
- yes
- Remarks:
- Purity of test substance not reported. No GLP statement. Limited reporting details.
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Legard
- Weight at study initiation: 1.97 kg
IN-LIFE DATES: 01 Mar 1991 to 08 Mar 1991 - Type of coverage:
- occlusive
- Preparation of test site:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: not stated
REMOVAL OF TEST SUBSTANCE
- Washing: no washing was performed
OBSERVATION TIME POINTS
1, 24, 48, and 72 h
SCORING SYSTEM:
No details reported. - Irritation parameter:
- erythema score
- Basis:
- animal: #1, #2, #3
- Remarks:
- individual mean over
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- edema score
- Basis:
- animal: #1, #2, #3
- Remarks:
- individual mean over
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting 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:
- according to guideline
- Guideline:
- other: Journal Officiel de la Republique Francoise 1971/1973
- Deviations:
- not specified
- Principles of method if other than guideline:
- Study was conducted prior to adoption of any OECD guideline.
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2.5-3.5 kg
- Housing: individual in 600x540x315 mm cages or in restraining devices
- Diet: 200g feed per day, commercial rabbit feed.
- Water: ad libitum
Animals were vaccinated against Myxomatosis and Pasteurellosis. Only healthy animals without signs of skin lesions were included.
ENVIRONMENTAL CONDITIONS
Air conditioned. - Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Remarks:
- back of rabbit, 14 cm x 14 cm clipped. Superficial incisions were made to the right flank.
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 mL of undiluted test substance
- Duration of treatment / exposure:
- 23 h
- Observation period:
- Readings at 24 and 72 hours after start of exposure.
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: Test substance was placed on two squares of sterile absorbent gauze measuring 2 cm x 2 cm; each square was composed of four layers of gauze. The gauze was placed on the left (intact skin) and right flank (incised skin) and held in contact with skin with an occlusive patch, which was adhesive and non-allergic. Additional an adhesive tape was wrapped around the animals.
SCORING SYSTEM:
Erythema: 0 (no), 1 (slight), 2 (well defined), 3 (moderate to severe), 4 (severe with slight eschar formation - injury in depth)
Edema: 0 (no), 1 (very slight), 2 (slight - definite raising), 3 (moderate), 4 (severe) - Irritation parameter:
- edema score
- Remarks:
- intact skin
- Basis:
- animal: #1, #2, #3, #4, #5, #6
- Remarks:
- individual mean over
- Time point:
- other: 24h/72h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other:
- Remarks:
- left flank
- Irritation parameter:
- erythema score
- Remarks:
- intact skin
- Basis:
- animal: #1, #2, #3, #4, #5, #6
- Remarks:
- individual mean over
- Time point:
- other: 24h/72h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other:
- Remarks:
- left flank
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- 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 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted in 1981
- Deviations:
- not applicable
- Qualifier:
- according to guideline
- Guideline:
- other: Journal Officiel de la Republique Francaise 1971/1973
- Deviations:
- not specified
- Principles of method if other than guideline:
- Study was conducted prior to adoption of any OECD guidelines.
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: about 2.5 kg at study start
Animals were vaccinated against myxomatosis and selected only if normal eye condition; any rabbits with ocular lesions were excluded.
- Housing: Individual cages (600x540x315 mm) or restraining devices
- Diet: 200 g commercial rabbit feed per day in the form of granules
- Water: ad libitum
- Climate: air conditioned - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: yes, each animals untreated right eye served as control
- Amount / concentration applied:
- 0.1 mL of undiluted test substance as supplied by sponsor was instilled to the left eye.
- Duration of treatment / exposure:
- Single instillation
- Observation period (in vivo):
- Readings were after 1, 24, 48, 72 hours, and 4 and 7 days after administration
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
No rinsing of eyes was done.
SCORING SYSTEM:
Chemosis: Scores 0-4
Conjunctival enanthema: Scores 0-3
Iris: Scores 0-2
Corneal opacity: Scores 0-4
TOOL USED TO ASSESS SCORE: ophtalmoscope - Irritation parameter:
- chemosis score
- Basis:
- animal: #1, #3, #6
- Remarks:
- individual mean over
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- individual mean over
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal: #4, #5
- Remarks:
- individual mean over
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #2, #3, #4, 5#, #6
- Remarks:
- individual mean over
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Remarks:
- individual mean over
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2, #3, #4, #6
- Remarks:
- individual mean over
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1, #3, #5, #6
- Remarks:
- individual mean over
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #2, #4
- Remarks:
- individual mean over
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not applicable
- Other effects:
- No mortality occurred during this study.
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.
Reference
|
|
Animal # |
|
|
|
|
|
|
Reading time [hour] |
#1 |
#2 |
#3 |
#4 |
#5 |
#6 |
Chemosis |
24 |
0 |
1 |
0 |
0 |
0 |
1 |
Chemosis |
48 |
1 |
1 |
1 |
0 |
0 |
0 |
Chemosis |
72 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Individual mean |
0.33 |
0.67 |
0.33 |
0.0 |
0.0 |
0.33 |
Redness conjunctivae |
24 |
1 |
0 |
1 |
0 |
1 |
1 |
Redness conjunctivae |
48 |
0 |
0 |
0 |
0 |
0 |
0 |
Redness conjunctivae |
72 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Individual mean |
0.33 |
0.0 |
0.33 |
0.0 |
0.33 |
0.33 |
Iris |
24 |
0 |
0 |
0 |
0 |
1 |
0 |
Iris |
48 |
0 |
0 |
0 |
0 |
0 |
0 |
Iris |
72 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Individual mean |
0.0 |
0.0 |
0.0 |
0.0 |
0.33 |
0.0 |
Cornea opacity |
24 |
0 |
0 |
0 |
0 |
0 |
0 |
Cornea opacity |
48 |
0 |
0 |
0 |
0 |
0 |
0 |
Cornea opacity |
72 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Individual mean |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
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.
Skin irritation
A skin irritation study was conducted with Propylene dinonanoate (CAS 41395-83-9) according to OECD guideline 404 (key study, 1991). 0.5 mL of the undiluted test substance was applied to the skin of 3 male rabbits for 4 hours of exposure under occlusive conditions. The skin irritation effects were scored at 1, 24, 48 and 72 hours. No signs of skin irritation were observed. The individual mean oedema and erythema scores over 24/48/72 hours were 0.0 for each of the 3 rabbits. The results of the study indicate no skin irritation potential.
A skin irritation study was conducted with Propylene dinonanoate (CAS 41395-83-9) similar to OECD guideline 404 (supporting study, 1977). 0.5 mL of the undiluted test substance was applied to the clipped, intact skin of 6 rabbits for 23 hours of exposure under occlusive conditions. The skin irritation effects were scored at 24 and 72 hours after start of exposure. No signs of skin irritation were observed. The individual mean oedema and erythema scores over 24/72 hours after start of exposure were 0.0 for each of the 6 rabbits. The results of the study indicate no skin irritation potential.
A single patch test with 10 healthy adult female volunteers was conducted with Propylene dinonanoate (CAS 41395-83-9). 0.02 mL of the undiluted test substance were applied on the back, on a surface of about 50 mm², on a filter paper and were occlusively covered with a "Finn Chamber" (aluminium disc) and held in place with an adhesive tape. The test article was applied only once. After an exposure of 48 h, patches were removed and substantial amount of remaining test material was removed using a hydrophilic pad. Macroscopic examination of the skin was done about 30 minutes after patch removal. No skin reactions were observed in any of the 10 volunteers. The test substance was well tolerated.
Based on the results of the available studies Propylene dinonanoate (CAS 41395-83-9) is not irritating to skin.
Eye irritation
An eye irritation study was conducted with Propylene dinonanoate (CAS 41395-83-9) similar to OECD guideline 405 (key study, 1977). 0.1 mL of undiluted test substance was instilled into one eye of each of 6 New Zealand White rabbits. The animals were observed for 7 days. Scoring according to the Draize system was performed 1, 24, 48, 72 hours, and 4 and 7 days after instillation. Only mild signs of eye irritation were seen, which were all fully reversible within 72 hours. The individual mean conjunctivae scores over 24/48/72 hours were 0.33 in 4/6 and 0.0 in 2/6 rabbits. The individual mean chemosis scores over 24/48/72 hours were 0.67 in 1/6, 0.33 in 3/6 and 0.0 in 2/6 rabbits. The individual mean cornea opacity scores over 24/48/72 hours were 0.0 in 6/6 rabbits. The individual mean iris scores over 24/48/72 hours were 0.33 in 1/6 and 0.0 in 5/6 rabbits. Under the conditions of the study, the test substance showed no eye irritation potential leading to classification.
Overall conclusion for skin and eye irritation
No skin and only mild eye irritation potential was shown for Propylene dinonanoate (CAS 41395-83-9).
Justification for classification or non-classification
The available in vivo data on skin and eye irritation do not meet the classification criteria according to Regulation (EC) 1272/2008 and are therefore conclusive but not sufficient for classification.
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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