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EC number: 269-027-5 | CAS number: 68171-38-0
- 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, rabbit (OECD 404): not irritating
Eye, rabbit (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:
- 27 Jun to 08 Aug 1989
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted in 1981
- Deviations:
- yes
- Remarks:
- purity not reported; assessed 24, 48 and 72h after application, not after patch removal
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted in 2015
- Deviations:
- yes
- Remarks:
- Limited documentation details, no rationale for in vivo testing
- Qualifier:
- according to guideline
- Guideline:
- other: 67/548/CEE
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage des Feuilletas
- Age at study initiation: not given
- Weight at study initiation: 2 +/- 0.2 kg
- Housing: individual in stainless steel cages (61 x 46 x 34 cm), grid floor
- Diet: rabbit feed, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 5
- Humidity (%): 55 +/- 25
- Air changes (per hr): 14
- Photoperiod (hrs dark / hrs light):12/12
IN-LIFE DATES: From: 27 Jun to 03 Jul 1989 - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Remarks:
- with a fine comb electric clipper to obtain a skin area of approx. 14 x 14 cm
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: contralateral side was applied with distilled water as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): unchanged - Duration of treatment / exposure:
- 4h
- Observation period:
- 7 days
Readings at 24h, 48h, 72h, 6d, and 7d after application and at 1h after removal of dressing - Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm² square
- Type of wrap if used: Test substance (or water on contralateral body side) was applied on a Codex hydrophilic eight layer gauze, about 2.5 cm², which was laid down on the skin. The gauze was kept in contact with skin using a hypoallergenic microporous adhesive strip. The whole was then covered with a stretchable band (fixed with adhesive tape) wrapped round the animal.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): none
OBSERVATION TIME POINTS
1 hour after removal of dressing; 24 hours, 48 hours, 72 hours, 6 days, and 7 days after application
SCORING SYSTEM:
- Method of calculation: erythema and edema scores from 0-4. - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- mean over
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- mean over
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- mean over
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- edema score
- Basis:
- animal: #1 and #2
- Remarks:
- mean over
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- mean over
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritant / corrosive response data:
- Three animals were tested.
The individual mean erythema scores over 24/48/72 hours were 0.66, 0.66, and 1.0.
The individual mean oedema scores over 24/48/72 hours were 0.33, 0.0, and 0.0. - Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.
Reference
Erythema Draize scores, 4h semi-occlusive, 0.5 mL unchanged test substance, NZW rabbits
Animal # |
24 h |
48 h |
72 h |
Day 6 |
Day 7 |
1 |
1 |
1 |
0 |
0 |
0 |
2 |
1 |
1 |
0 |
0 |
0 |
3 |
1 |
1 |
1 |
0 |
0 |
Oedema Draize scores, 4h semi-occlusive, 0.5 mL unchanged test substance, NZW rabbits
Animal # |
24 h |
48 h |
72 h |
Day 6 |
Day 7 |
1 |
0 |
0 |
0 |
0 |
0 |
2 |
1 |
0 |
0 |
0 |
0 |
3 |
0 |
0 |
0 |
0 |
0 |
Erythema Draize scores, 4h semi-occlusive, 0.5 mL aqua dest., NZW rabbits
Animal # |
24 h |
48 h |
72 h |
Day 6 |
Day 7 |
1 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
3 |
0 |
0 |
0 |
0 |
0 |
Oedema Draize scores, 4h semi-occlusive, 0.5 mL aqua dest., NZW rabbits
Animal # |
24 h |
48 h |
72 h |
Day 6 |
Day 7 |
1 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
3 |
0 |
0 |
0 |
0 |
0 |
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
- Study period:
- 26 Jun to 08 Aug 1989
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted in 1987
- Deviations:
- yes
- Remarks:
- no purity reported
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted in 2017
- Deviations:
- yes
- Remarks:
- Limited documentation, no in vivo testing rationale
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Elevage des Feuilletas
- Age at study initiation: not given
- Weight at study initiation: 2 +/- 0.2 kg
- Housing: individual in stainless steel cages (61 x 46 x 34 cm), grid floor
- Diet: rabbit feed, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 5
- Humidity (%): 55 +/- 25
- Air changes (per hr): 14
- Photoperiod (hrs dark / hrs light):12/12
IN-LIFE DATES: From: 26 Jun to 03 Jul 1989 - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): unchanged product as provided by sponsor
- Duration of treatment / exposure:
- single instillation
- Observation period (in vivo):
- 72 hours
Readings at 1h, 24h, 48h, and 72h after instillation - Number of animals or in vitro replicates:
- 3
- Details on study design:
- SCORING SYSTEM: Chemosis (0-4), Conjunctiva redness (0-3), Iris (0-2), Cornea opacity (0-4)
Eyes were assessed 1, 24, 48 and 72 hours after instillation - Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1 and #3
- Remarks:
- mean over
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Remarks:
- mean over
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2, #3
- Remarks:
- mean over
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1, #2, #3
- Remarks:
- 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
- Remarks:
- 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.
Reference
Single instillation, 0.1 mL unchanged test substance, NZW rabbits
Conjunctivae Draize score
Animal # |
24h |
48h |
72h |
1 |
0 |
0 |
0 |
2 |
1 |
0 |
0 |
3 |
0 |
0 |
0 |
Iris Draize score
Animal # |
24h |
48h |
72h |
1 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
3 |
0 |
0 |
0 |
Chemosis Draize score
Animal # |
24h |
48h |
72h |
1 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
3 |
0 |
0 |
0 |
Corneal opacity Draize score
Animal # |
24h |
48h |
72h |
1 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
3 |
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 Isooctadecanoic acid, monoester with propane-1,2-diol (CAS 68171-38-0) according to OECD guideline 404 under GLP conditions (key, 1989). 0.5 mL of the liquid test substance was applied to the clipped skin of 3 New Zealand White rabbits for 4 hours of exposure under semi-occlusive conditions. The skin irritation effects were scored 1, 20, 44 and 68 hours after patch removal. Slight erythema (score 1) was found in 3/3 at 24 and 48 hours after application and in 1/3 animal at 72 hours after application. No erythema was found 6 and 7 days after application. The individual mean erythema scores over 24/48/72 hours were 0.66, 0.66, and 1.0. Slight oedema was found in 1/3 animals at 24 hours after application. The individual mean oedema scores over 24/48/72 hours were 0.33, 0.0, and 0.0. The results of the study did not meet CLP/EU GHS criteria for a skin irritating potential.
Eye irritation
Isooctadecanoic acid, monoester with propane-1,2-diol (CAS 68171-38-0) was examined for its eye irritation potential in a study performed according to OECD guideline 405 under GLP conditions (key, 1989). 0.1 mL of undiluted test substance was instilled into one eye of each of 3 New Zealand White rabbits. The animals were observed for 72 hours and scoring according to Draize was performed 1, 24, 48, and 72 hours after instillation. Slight conjunctival redness (score 1) was seen in 1/3 rabbits at 24 hours. The effect had cleared completely within 48 hours. The individual mean conjunctivae scores over 24/48/72 hours were 0.33, 0.0, and 0.0. No other eye irritation effects were observed in any rabbit at any time point. The individual mean iris, chemosis, and cornea opacity scores over 24/48/72 hours were 0.0 in all three animals. Under the conditions of the study, the test substance showed no eye irritating potential.
Overall conclusion for skin and eye irritation
No skin or eye irritation potential was shown for Isooctadecanoic acid, monoester with propane-1,2-diol (CAS 68171-38-0).
Justification for classification or non-classification
The available 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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