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EC number: 940-683-0 | CAS number: -
- 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
Two GLP studies on skin and eye irritation have been carried out on read-cross substance (CAS No 67762-38-3). The substance is neither a skin nor an eye irritant.
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:
- From 1984-03-26 to 1984-07-31
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was performed according to OECD guideline 404 and GLP. Test on read-cross substance used for this registration (CAS No 67762-38-3)
- Justification for type of information:
- This read-across is based on the hypothesis that source and target substances have similar toxicological properties. Both are UVCB substances being mixtures of fatty acid esters. Both are hydrolysed enzymatically to common products, i.e. the same fatty acids and to non-common products, i.e. methanol and ethanol in the case of the source substances respectively the target source. Methanol and ethanol have similar toxicological profiles. A read-across justification document is attached in section 13.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Principles of method if other than guideline:
- NA
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- other: New Zealand White: Hy/Cr
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River France (76410 Saint Aubin les Elbeuf, France)
- Age at study initiation: no data
- Weight at study initiation: 2.35 kg +/- 0.05 kg
- Housing: individually in polystyrene cage (35 x 55 x 32 cm).
- Diet: rabbit diet SQC (Special diets Services Ltd, Witham, Essex, England), ad libitum
- Water: filtered water with 0.22 µm Millipore membrane (Millipore, 67120 Molsheim, France), ad libitum
- Acclimation period: 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C +/- 3°C
- Humidity (%): 50 % +/- 20 %
- Air changes (per hr): no data (filtered Air)
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light
IN-LIFE DATES: From: 1984-05-18 To: 1984-05-21 - Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated left flank
- Amount / concentration applied:
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 3 days
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: right flank (6 cm2)
- % coverage: no data
- Type of wrap if used: A gauze pad was applied on the tested area and was held in contact with the skin by means of an adhesive hypoallergenic
semi-occlusive dressing.
REMOVAL OF TEST SUBSTANCE: No
SCORING SYSTEM: according to the grading of skin reactions described in OECD guideline 404. - Other effects / acceptance of results:
- NA
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72h
- Score:
- > 0 - < 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Slight erythema was observed in all animals after one hour exposure and disappeared completely after 3 days. No edema was reported.
See table 1 in field "Remarks on results including tables and figures". - Other effects:
- No other local or systemic effects were observed.
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: EU-GHS
- Conclusions:
- Metiloil A was not considered to be a skin irritant.
- Executive summary:
In a primary dermal irritation study (Kaysen A., 1984), young adult New Zealand White rabbits (6 males) were exposed by dermal contact to 0.5 ml of Metiloil A (batch No. 1169) (CAS No 67762-38-3) onto one flank. Test sites were covered with a semi-occlusive dressing for 4 hours. Animals then were observed for 3 days. Irritation was scored by the grading of skin reactions described in the OECD guideline 404. Slight erythema was observed in all animals after one hour exposure and disappeared completely after 3 days. No edema was observed. Mean scores over 1, 24, 48 and 72 hours were 2, 0.33, 0 and 0 for erythema and 0, 0, 0 and 0 for edema, respectivelly.
In this study, metiloil A is slightly irritating when applied topically to rabbit skin, but not classified according to the EU-GHS criteria.
Reference
Table1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test
Score at time point/ Reversibility | Erythema Max. score: 4 |
Edema Max. score: 4 |
60 min |
2/2/2/2/2/2 | 0/0/0/0/0/0 |
24 h |
0/1/0/1/0/0 | 0/0/0/0/0/0 |
48 h |
0/0/0/0/0/0 | 0/0/0/0/0/0 |
72 h |
0/0/0/0/0/0 | 0/0/0/0/0/0 |
Average 24h, 48h, 72h |
0.33/0/0 | 0 |
Reversibility*) |
c. | - |
*) Reversibility: c.=completely reversible; n.c.= not completely reversible; n= not reversible
Grading of skin reactions:
Erythema and Eschar Formation
0 = No erythema
1 = Very slight erythema (barely perceptible)
2 = Well defined erythema
3 = Moderate to severe erythema
4 = Severe erythema (beef redness) to eschar formation preventing grading of erythema
Edema Formation
0 = No edema
1 = Very slight edema (barely perceptible)
2 = Slight edema (edges of area well defined by definite raising)
3 = Moderate edema (raised approximately 1 mm)
4 = Severe edema (raised more than 1 mm and extending beyond area of exposure)
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:
- From 1984-03-26 To 1984-07-30
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- This read-across is based on the hypothesis that source and target substances have similar toxicological properties. Both are UVCB substances being mixtures of fatty acid esters. Both are hydrolysed enzymatically to common products, i.e. the same fatty acids and to non-common products, i.e. methanol and ethanol in the case of the source substances respectively the target source. Methanol and ethanol have similar toxicological profiles. A read-across justification document is attached in section 13.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Principles of method if other than guideline:
- NA
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- other: New Zealand White: Hy/Cr
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River France (76410 Saint Aubin les Elbeuf, france)
- Age at study initiation: no data
- Weight at study initiation: 2.4 kg +/- 0.1 kg
- Housing: individually in polystyrene cage (35.0 x 55.0 x 32.0 cm)
- Diet: rabbit diet SQC (Special diets Services Ltd, Witham, Essex, England), ad libitum
- Water: filtered water with 0.22 µm Millipore membrane (Millipore, 67120 Molsheim, France), ad libitum
- Acclimation period: 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C +/- 3°C
- Humidity (%): 50 % +/- 20 %
- Air changes (per hr): no data (filtered air)
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light
IN-LIFE DATES: From: 1984-05-18 To: 1984-05-20 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: right eye
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml - Duration of treatment / exposure:
- not rinsed
- Observation period (in vivo):
- 3 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE: not rinsed
SCORING SYSTEM: similar to grading of ocular lesion described in 405 OECD guideline.
- Other effects / acceptance of results:
- NA
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: no effect
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48, 72h
- Score:
- 0.16
- Max. score:
- 3
- Reversibility:
- fully reversible within: 1 day
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: no effect
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, 72h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: no effect
- Irritant / corrosive response data:
- Conjunctivae effects were observed 1 hour after exposure. Slight chemosis and slight conjunctivae were observed in two animals and four animals, respectively. Two animals presented conjunctivae with diffuse, crimson colour and individual vessels not easily discernible. These effects were fully reversible within 1 day.
- Other effects:
- No data
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: EU-GHS
- Conclusions:
- Metiloil A was not considered to be an eye irritant.
- Executive summary:
In a primary eye irritation study (Kaysen A., 1984), 0.1 ml of Metiloil A (batch No. 1169) was instilled into the conjonctival sac of 6 New Zealand white male rabbits. Animals then were observed for 3 days. Slight irritation was observed one hour after treatment. Slight chemosis and slight conjunctivae were observed in two animals and four animals, respectively. Two animals presented conjunctivae with diffuse, crimson colour and individual vessels not easily discernible. Effects were reversible within one day. In this study, Metiloil A was not considered as an eye irritant based on EU-GHS.
Reference
Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test
Score at time point/ Reversibility | Cornea Max. score: 4 |
Iris Max. score: 2 |
Conjunctivae Max. score: 3 |
Chemosis Max. score: 4 |
60 min | 0/0/0/0/0/0 | 0/0/0/0/0/0 | 2/1/1/1/1/2 | 0/0/0/1/1/0 |
24 h | 0/0/0/0/0/0 | 0/0/0/0/0/0 | 1/0/0/1/0/1 | 0/0/0/0/0/0 |
48 h | 0/0/0/0/0/0 | 0/0/0/0/0/0 | 0/0/0/0/0/0 | 0/0/0/0/0/0 |
72 h | 0/0/0/0/0/0 | 0/0/0/0/0/0 | 0/0/0/0/0/0 | 0/0/0/0/0/0 |
Average 24h, 48h, 72h |
0 | 0 | 0.16 | 0 |
Reversibility*) | - | - | c. | c. |
*) Reversibility: c.=completely reversible; n.c.= not completely reversible; n= not reversible
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Based on GLP studies on the read-cross substance (CAS No 67762 -38 -3), the target substance Fatty acids, C18 (saturated and unsaturated) ethyl esters is not considered either a skin nor an eye irritant. In support for evaluation of eye irritation of Fatty acids, C18 (saturated and unsaturated) ethyl esters, no in vivo irritation potential was identified using the Hen's Egg Test utilizing the Chorioallantoic Membrane (HET-CAM). In terms of skin irritation, no skin irritation was seen in a human patch repeated insult patch test (HRIPT) using Bioester XP 3511F (atty acids, C18 (saturated and unsaturated) ethyl esters).
Justification for selection of skin irritation / corrosion endpoint:
GLP study on read-cross substance (CAS No 67762-38-3)
Justification for selection of eye irritation endpoint:
GLP study on read-cross substance (CAS No 67762-38-3)
Justification for classification or non-classification
Not classified. The test data shows that the target substance Fatty acids, C18 (saturated and unsaturated) ethyl ester is not considered to be a skin or eye irritant.
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