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EC number: 292-792-1 | CAS number: 90990-29-7
- 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/corrosion: not irritating
Eye irritation (similar to OECD 405): not irritating
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:
- weight of evidence
- Study period:
- 15 - 18 Jan 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- - Principle of test: 6 New Zealand albino rabbits were exposed dermally under occlusive conditions to the undiluted test substance for 24 h. The test substance was applied to abraded and non-abraded skin sites. The skin was observed for erythema and edema (Draize scoring system) 1 and 48 h after removal of the test substance.
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Nottingham University, School of Agriculture, Nottingham, UK
- Weight at study initiation: 2.59 - 3.35 kg (range: males and females)
- Housing: individually in suspended metal cages
- Diet: rabbit diet (John Waring (Feeds) Limited, Shardlow, Derbyshire, UK), ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Air changes (per hr): at least 20
- Photoperiod (hrs dark / hrs light): 12 / 12
- Type of coverage:
- occlusive
- Preparation of test site:
- other: clipped and abraded
- Remarks:
- test site on right flank of the animals
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 mL - Duration of treatment / exposure:
- 24 h
- Observation period:
- 48 h
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: The test substance was introduced under a composite patch which consisted of a 2.5 cm square of absorbent lint B.P.C. backed by a 2.5 cm square of polythene with a final backing of a 4 cm square of lint. The patch was held in position by two lengths of sleek adhesive strapping in the form of a cross.
REMOVAL OF TEST SUBSTANCE
- Washing: Any residual test material was removed by gentle swabbing the test site with cotton wool soaked in lukewarm water.
- Time after start of exposure: 24 h
OBSERVATION TIME POINTS
1 and 48 h after removal of the patches
SCORING SYSTEM: Draize scoring system - Irritation parameter:
- erythema score
- Basis:
- animal: #3
- Time point:
- other: 1 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- erythema score
- Basis:
- animal: #1, #2, #4, #5 and #6
- Time point:
- other: 1 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not apllicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- other: 1 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- Intact skin:
At the 1-h reading time point, very slight erythema (score 1) was observed in 1/6 animals. The erythema had cleared completely within 48 hours after patch removal. No oedema was observed in any animal at any time reading time point.
Abraded skin:
Very slight erythema (score 1) was observed in 2/6 animals 1 h after patch removal. All evidence of irritation had disappeared 48 h after patch removal. - Interpretation of results:
- other: Study can not be used for classification
- Conclusions:
- The result of the in vivo skin irritation study is not conclusive with respect to non-classification or classification as a skin irritant and therefore requires further evaluation and/or data generation.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 26 -29 May 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- The analytical purity of the test substance was not specified.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: ESD (Chatillon sur Chalaronne, France)
- Weight at study initiation: 2-2.5 kg
- Housing: animals were housed individually in stainless steel cages with a wiremesh floor
- Diet: Food ref. 110-10 (U.A.R., Epinay sur Orge, France), ad libitum
- Water: filtered tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-22
- Humidity (%): 30-80
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 26 May 1999 To: 29 May 1999 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: not required, untreated sites of the same animal served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 h
- Observation period:
- 3 days
Reading time points: 1, 24, 48 and 72 h - Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: a gauze patch covering the test site was held in place by micropore tape; the trunk of the animals was wrapped in an elastic gauze band and semiocclusive, adhesive tape. Access to the test site was restricted with a plastified aerated wrapping fixed to the trunk of the animals with velcro tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the remnants of the test substance were removed with distilled water or, if necessary, a suitable solvent
- Time after start of exposure: 4 h
SCORING SYSTEM: Draize scoring system - Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- No skin irritation effects were observed at any time point in any animal.
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
Referenceopen allclose all
Table 1. Results of irritation test on intact and abraded skin sites 1h and 48 h after patch removal
Observation time |
Rabbit no. |
|||||||||||
1 |
2 |
3 |
4 |
5 |
6 |
|||||||
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
|
Intact skin |
||||||||||||
1 h |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
48 h |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Abraded skin |
||||||||||||
1 h |
0 |
0 |
1 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
48 h |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
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:
- 28 - 31 Jan 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- limited documentation; no analytical purity of test substance given
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted Oct 2012
- Deviations:
- yes
- Remarks:
- limited documentation; no analytical purity of test substance given
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Nottingham University, School of Agriculture, Nottingham, UK
- Weight at study initiation: 2.00 - 2.42 kg (range: males and females)
- Housing: individually in suspended metal cages
- Diet: rabbit diet (J. Waring (Feeds) Limited, Shardlow, Derbyshire, UK), ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Air changes (per hr): at least 20
- Photoperiod (hrs dark / hrs light): 12 / 12
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: left eye remained untreated and served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 mL
- Duration of treatment / exposure:
- single application without washing
- Observation period (in vivo):
- 72 h
Reading time points: 24, 48 and 72 h - Number of animals or in vitro replicates:
- 6
- Details on study design:
- SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: ophthalmoscope; Observation of corneal opacity was carried out under ultra-violet illumination preceded by the instillation of fluorescein into the eye. - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1, #4 and #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #2, #3 and #6
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal: #2, #3, #4 and #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritant / corrosive response data:
- 3/6 animals showed conjunctival redness (score 1) 24 and 48 h after instillation, reversible within 72 h. 2/6 animals showed conjunctivae chemosis (score 1) 24 h after instillation of test substance, in one animal reversible within 48 h, in the second animal reversible within 72 h.
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.
Reference
Table 1. Results of eye irritation study.
Alteration |
Animal No. |
Time (h) |
||||
24 |
48 |
72 |
mean 24/48/72 h |
reversible within |
||
Cornea |
1 |
0 |
0 |
0 |
0 |
- |
2 |
0 |
0 |
0 |
0 |
- |
|
3 |
0 |
0 |
0 |
0 |
- |
|
4 |
0 |
0 |
0 |
0 |
- |
|
5 |
0 |
0 |
0 |
0 |
- |
|
6 |
0 |
0 |
0 |
0 |
- |
|
Iris |
1 |
0 |
0 |
0 |
0 |
- |
2 |
0 |
0 |
0 |
0 |
- |
|
3 |
0 |
0 |
0 |
0 |
- |
|
4 |
0 |
0 |
0 |
0 |
- |
|
5 |
0 |
0 |
0 |
0 |
- |
|
6 |
0 |
0 |
0 |
0 |
- |
|
Conjunctivae Redness |
1 |
0 |
0 |
0 |
0 |
- |
2 |
1 |
1 |
0 |
0.67 |
72 h |
|
3 |
1 |
1 |
0 |
0.67 |
72 h |
|
4 |
0 |
0 |
0 |
0 |
- |
|
5 |
0 |
0 |
0 |
0 |
- |
|
6 |
1 |
1 |
0 |
0.67 |
72 h |
|
Conjunctivae Chemosis |
1 |
1 |
1 |
0 |
0.67 |
72 h |
2 |
0 |
0 |
0 |
0 |
- |
|
3 |
0 |
0 |
0 |
0 |
- |
|
4 |
0 |
0 |
0 |
0 |
- |
|
5 |
0 |
0 |
0 |
0 |
- |
|
6 |
1 |
0 |
0 |
0.33 |
48 h |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Analogue justification
There are substance-specific data available on the skin and eye irritation potential of Fatty acids, C16 and C18-22 - unsatd., C16-18 and C18 unsatd. alkyl ester (CAS 90990-29-7). Additional data on the skin irritation potential of was provided using studies conducted with an analogue substance as part of a read across approach, which is in accordance with Regulation (EC) No. 1907/2006, Annex XI, 1.5. For each specific endpoint the source substance(s) structurally closest to the target substance is/are chosen for read-across, with due regard to the requirements of adequacy and reliability of the available data. Structural similarities and similarities in properties and/or activities of the source and target substance are the basis of read-across. A detailed justification for the analogue read-across approach is provided in the technical dossier (see IUCLID Section 13).
Skin irritation
In vivo
CAS 90990-29-7
A skin irritation study was performed with Fatty acids, C16 and C18-22 - unsatd., C16-18 and C18 unsatd. alkyl ester (CAS 90990-29-7) (Key, 1982). No current guideline was followed. 0.5 mL of the undiluted test substance was applied to the clipped or clipped and abraded skin of 6 New Zealand White rabbits and held in place by an occlusive dressing for 24 h. The severity of erythema and edema was scored 1 and 48 h after patch removal. The test material produced minimal erythema (score 1) in 1/6 rabbits at the intact test site and in 2/6 rabbits at the abraded test site, respectively, 1 h after patch removal. All skin irritation effects were reversible within 48 h after patch removal. No other skin irritation effects were observed in any animal (6/6) at any reading time point. Due to the short observation period, the results are not suitable for determining the classification or non-classification of the substance.
CAS 72576-80-8
A skin irritation study was performed with Hexadecanoic acid isooctadecyl ester (CAS 72576-80-8), according to EU Method B.4 and under GLP conditions (Key, 1999). 0.5 mL of the test substance was applied to the shaved skin of 3 New Zealand White rabbits and held in place by a semi-occlusive dressing for 4 h. The severity of erythema and edema was scored 1, 24, 48 and 72 h after patch removal. No skin irritation was observed at any time point in any animal; all erythema and edema scores were 0. The test substance is not considered to be irritating to the skin.
Human data
CAS 17671-27-1
In a single exposure patch test (24h single patch test, 2005) the undiluted Docosyl docosanoatewas applied to the back skin of 11 volunteers for 24 h under occlusive conditions. The skin irritation effects (erythema and edema) were assessed 30 minutes and 24 h after patch removal. Slight to moderate erythema (score 1-1.5) was observed at the test site in 3/10 subjects at the 30-minute reading time point and in 1/10 subjects 24 h after patch removal. The positive control (1% sodium sulphate) was shown to be valid. 1/11 subjects were excluded as moderate erythema was noted at the negative control site (water).
Eye irritation
CAS 90990-29-7
The eye irritation potential of Fatty acids, C16 and C18-22 - unsatd., C16-18 and C18 unsatd. alkyl ester was investigated in six albino rabbits, following a protocol similar to OECD guideline 405 (Key, 1982) and in compliance with GLP. 0.1 g of the test substance was instilled into one eye of each animal. The other eye remained untreated and served as control. The eyes were examined and scored according to the Draize scoring system 24, 48 and 72 h after application.
3/6 animals showed conjunctival redness (score 1) 24 and 48 h after instillation, reversible within 72 h. 2/6 animals showed conjunctivae chemosis (score 1) 24 h after instillation of test substance, in one animal reversible within 48 h, in the second animal reversible within 72 h. The cornea and iris were not affected. The mean 24/48/72 h scores of all 6 animals for redness were 0.0, 0.67, 0.67, 0.0, 0.0 and 0.67, respectively , while mean 24/48/72 h scores for chemosis were 0.67, 0.0, 0.0, 0.0, 0.0 and 0.33,respectivley. Based on the results of this study, the test substance is not considered to be irritating to the eyes. 3/6 animals showed conjunctival redness (grade 1) 24 and 48 h after instillation, reversible within 72 h. 2/6 animals showed conjunctivae chemosis (grade 1) 24 h after instillation of test substance, in one animal reversible within 48 h, in the second animal reversible within 72 h.
Overall conclusion for skin and eye irritation
The available data on the target and source substances did not show any skin or eye irritation effects. Therefore, the target substance Fatty acids, C16 and C18-22 - unsatd., C16-18 and C18 unsatd. alkyl ester (CAS 90990-29-7) is not considered to be a skin irritant .The data on eye irritation indicates that Fatty acids, C16 and C18-22 - unsatd., C16-18 and C18 unsatd. alkyl ester is not an eye irritant.
Justification for classification or non-classification
According to Article 13 of Regulation (EC) No. 1907/2006 "General Requirements for Generation of Information on Intrinsic Properties of substances", information on intrinsic properties of substances may be generated by means other than tests e.g. from information from structurally related substances (grouping or read-across), provided that conditions set out in Annex XI are met. Annex XI, "General rules for adaptation of this standard testing regime set out in Annexes VII to X” states that “substances whose physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity may be considered as a group, or ‘category’ of substances. This avoids the need to test every substance for every endpoint". Since the analogue concept is applied to Fatty acids, C16 and C18-22 - unsatd., C16-18 and C18 unsatd. alkyl ester (CAS 90990-29-7), data will be generated from data for reference source substance(s) to avoid unnecessary animal testing. Additionally, once the analogue read-across concept is applied, substances will be classified and labelled on this basis.
Therefore, based on the target substance information and analogue read-across approach, the available data on skin and eye irritation do not meet the criteria for classification according to Regulation (EC) No 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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