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EC number: 241-644-4 | CAS number: 17671-26-0
- 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 irritation (similar to OECD 404, read across): not irritating
Eye irritation (OECD 492): 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:
- key study
- Study period:
- 11 - 21 Mar 1991
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- The exposure was performed under occlusive conditions, the analytical purity of the test substance was not specified.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- occlusive exposure
- Principles of method if other than guideline:
- The testing was performed equivalent to OECD guideline 404.
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated skin site of the same animal served as the control
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
Reading time points: 1, 24, 48 and 72 h - Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Type of wrap if used: occlusive
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the treated site was not washed after patch removal
SCORING SYSTEM: Draize scoring system - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- mean over
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- mean over
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- 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 #1
- Remarks:
- mean over
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- edema score
- Basis:
- animal #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
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritant / corrosive response data:
- 1 hour after exposure, all the animals had slight to well-defined erythema, while 2/3 had very slight to slight edema. These effects gradually reduced in severity. 24 hours after exposure ended, 1/3 animals had very slight erythema and slight edema. the edema persisted until the 48-hour reading time point.All skin irritation effects had cleared completely within 72 hours after the exposure ended.
- 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
- Study period:
- 09 May 1989 - 17 Jul 1990
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- (analytical purity of test substance not specified, occlusive exposition).
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted in 1981
- Deviations:
- yes
- Remarks:
- occlusive exposition, analytical purity of test material not specified
- 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
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- other: Kleinrussen, Chbb:HM
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Thomae, Germany
- Age at study initiation: 8-12 months
- Weight at study initiation: approx. 2620 g
- Diet: ad libitum (Altromin-Haltungsdiat 2023)
- Water: ad libitum
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-25
- Humidity (%): 45-70
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated site 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:
- Reading time points: 1, 24, 48, 72h and 7 days
7 days - Number of animals:
- 4
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm²
- Type of wrap if used: inert plastic foil fixed with an adhesive patch (Leukosilk) and a special gauze bandage (Acrylastic)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No data
SCORING SYSTEM: Draize scoring system - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- mean over
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- 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: 7 d
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- mean over
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Remarks:
- mean over
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- mean over
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- edema score
- Basis:
- animal #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
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Remarks:
- mean over
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- The test substance, when administered to rabbit skin for 24h, caused only slight irritations that were fully reversible within 7 days.
- 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: Erythema and edema scores for skin irritation of the individual animals at different reading time points:
Observation time |
Rabbit no. |
|||||
1 |
2 |
3 |
||||
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
|
1 h |
2 |
2 |
1 |
0 |
1 |
1 |
24 h |
1 |
2 |
0 |
0 |
0 |
0 |
48 h |
0 |
1 |
0 |
0 |
0 |
0 |
72 h |
0 |
0 |
0 |
0 |
0 |
0 |
Mean value 24 + 48 + 72 h |
0.33 |
1.00 |
0 |
0 |
0 |
0 |
Mean value 24 + 48 + 72 h all animals |
0.11 |
0.33 |
|
|
|
|
Erythema Score
Animal Number |
1 h |
24 h |
48 h |
72 h |
7 d |
102 |
1 |
1 |
1 |
2 |
0 |
128 |
1 |
1 |
0 |
1 |
0 |
129 |
1 |
1 |
0 |
1 |
0 |
130 |
1 |
0 |
0 |
1 |
0 |
Edema Score
Animal Number |
1 h |
24 h |
48 h |
72 h |
7 d |
102 |
1 |
1 |
0 |
0 |
0 |
128 |
0 |
0 |
0 |
0 |
0 |
129 |
2 |
0 |
0 |
0 |
0 |
130 |
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 vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 17 July - 30 Jan 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
- Version / remarks:
- 9 October 2017
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Hess. Ministerium für Umwelt, Klimaschutz, Landwirtschaft und Verbraucherschutz, Wiesbaden, Germany
- Species:
- human
- Strain:
- other: EpiOcularTM (OCL-200-EIT)
- Details on test animals or tissues and environmental conditions:
- - Justification of the test method and considerations regarding applicability
The EpiOcularTM Eye Irritation Test (EIT) predicts the acute ocular irritation potential of chemicals by measurement of its irreversible tissue damage caused by cytotoxic effects in the human cornea model. The EpiOcular ™ Eye Irritation Test (EIT) was validated by the European Union Reference laboratory for Alternatives to Animal Testing (EURL ECVAM) and cosmetics Europe between 2008 and 2013. It is utilized for the classification and labelling of chemicals concerning their eye irritation potential. The EpiOcularTM EIT is intended to differentiate substances that require “no classification" as eye irritant from those that require labelling as either GHS category 1 or 2 for serious eye damage respective eye irritation potential.
- Description of the cell system used, incl. certificate of authenticity and the mycoplasma status of the cell live
The EpiOcularTM tissue consists of normal, human-derived keratinocytes which have been cultured to form a stratified squamous epithelium similar to that found in the human cornea. It consists of highly organized basal cells, which progressively flatten out as the apical surface of the tissue is approached, analogous to the normal in vivo corneal epithelium. The EpiOcularTM tissues (surface 0.6 cm²) were cultured on specially prepared cell culture inserts (MILLICELL®, 10 mm Ø). Analysis for tissue functionality and for potential contaminants was passed. - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 50 µL
- Concentration: undiluted - Duration of treatment / exposure:
- 30 min
- Duration of post- treatment incubation (in vitro):
- 120 min
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- - Details of the test procedure used
:
EpiOcularTM tissue model was used. After the assessment and exclusion of direct MTT reduction and colouring potential of the test substance, the well plates were prepared and the tissues were pre-incubated in warm medium under standard culture conditions (37 ± 1.5 °C, 5 ± 0.5 % CO2 and 95 % relative humidity). After overnight incubation, the tissues were pre-wetted with 20 μL DPBS buffer (Ca2+ Mg2+ free) and then incubated at standard culture conditions for 30 min. 50 μL of the controls and the neat test substance were then applied and incubated for 30 min at standard culture conditions. After exposure the tissue constructs were thoroughly rinsed and transferred to fresh medium for an immersion incubation at room temperature. Afterwards, the tissues were transferred to fresh medium and incubated for 120 min at standard culture conditions, prior to determination of the cytotoxic (irritancy) effect. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyl tetrazolium bromide (MTT) at the end of the treatment.
- RhCE tissue construct used, including batch number :
Keratinocyte strain: 4F1188, Lot Number: 27002
- Doses of test chemical and control substances used :
50 μL of undiluted test substance, 50 μL of demineralised water (negative control), 50 μL of methyl acetate (positive control)
- Duration and temperature of exposure, post-exposure immersion and post-exposure incubation periods:
30 min at 37.0 ± 1.5 °C, 12 min immersion incubation at room temperature, 120 min at 37 ± 1.5 °C post-exposure incubation
- Number of tissue replicates used per test chemical and controls (positive and negative control) : 2
- Wavelength used for quantifying MTT formazan : 570 nm
- Description of the method used to quantify MTT formazan : The amount of extracted formazan was determined spectrophotometrically at 570 nm in duplicate with a plate reader (Versamax® Molecular Devices, Ismaning, Germany). Then the mean OD of the blank isopropanol (OD Blk) was calculated, followed by the subtraction of mean OD Blk of each value of the same experiment (corrected values).
The mean OD of the two replicates for each tissue the mean OD of the two relating tissues for controls and test substance were then calculated.
To calculate the relative absorbance, the following equation was used: viability (%) = (OD corrected of test substance or positive control/ OD corrected of mean negative control)*100
- Description of evaluation criteria used including the justification for the selection of the cut-off point for the prediction model :
The in vitro eye irritation test is considered valid if it meets the following criteria:
a) mean OD570 of the negative control: > 0.8 and < 2.5
b) mean relative tissue viability of the positive control: < 50% relative to the negative control.
c) variation within replicates: <20%
If the test item-treated tissue viability is > 60% relative to the negative control treated tissue viability, the test item is labeled non-irritant (no Category according to UN GHS).
If the test item-treated tissue viability is ≤ 60% relative to negative control treated tissue viability, the test item is labeled irritant (Category 2 or Category 1 according to UN GHS; no differentiation between the categories possible).
- Reference to historical positive and negative control results demonstrating suitable run acceptance criteria : negative contrtol range: 1.27 - 2.16; positive control range: 6.9 - 43.4%
- Complete supporting information for the specific RhCE tissue construct used :
Tissue viability: 1.269 ± 0.039 (accepted range: 1.1 - 3.0)
Barrier function: ET-50: 24.36 min (accepted range: 12.2 - 37.5) - Irritation parameter:
- other: mean viability (%)
- Run / experiment:
- mean value of test substance
- Value:
- 95
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- other: mean viability (%)
- Run / experiment:
- mean value of positive control
- Value:
- 36.5
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Other effects / acceptance of results:
- DEMONSTRATION OF TECHNICAL PROFICIENCY:
yes, but not in this report
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes, mean OD = 1.691 (> 0.8 and < 2.5)
- Acceptance criteria met for positive control: yes, % viability = 36.5% (< 50%)
- Range of historical values if different from the ones specified in the test guideline: 0.6 - 2.1% (< 20%) - Interpretation of results:
- other: CLP/ EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- CLP: not classified
Reference
Table 1: Results of MTT assay
|
Tissue No. |
OD570 |
Mean (OD570) |
Mean (OD570) - blank |
Mean tissue viability (% of negative control) |
|
Negative control |
1 |
1.674 |
1.714 |
1.676 |
99.1 |
100 |
1.753 |
||||||
2 |
1.735 |
1.744 |
1.706 |
100.9 |
||
1.753 |
||||||
Positive control |
1 |
0.626 |
0.660 |
0.622 |
36.8 |
36.5 |
0.693 |
||||||
2 |
0.647 |
0.649 |
0.611 |
36.2 |
||
0.652 |
||||||
Test substance |
1 |
1.614 |
1.626 |
1.588 |
93.9 |
95.0 |
1.638 |
||||||
2 |
1.676 |
1.662 |
1.624 |
96.1 |
||
1.649 |
OD = optical density
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Read across justification
There are no available data on the skin irritation effects of Lauryl nonanoate (CAS 17671-26-0). The assessment was therefore based on studies conducted with analogue substances 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
CAS 95912-86-0
A skin irritation study similar to OECD guideline 404 (key study, 1991) was performed with Fatty acids, C8-10, C12-18-alkyl esters (CAS 95912-86-0). 0.5 mL of the undiluted test substance was applied to the shaved skin of 3 male rabbits for 4 hours of exposure under occlusive conditions. The local skin effects were scored 1, 24, 48, and 72 h after exposure ended. At the 24-hour reading time point 1/3 rabbits showed erythema (score 1), which was fully reversible within 48 hours. Oedema was seen in 1/3 rabbits with score 2 at the 24-hour reading and score 1 at the 48 hour reading, which was fully reversible within 72 hours.
The mean erythema scores (over 24, 48 and 72 hours) were 0.33, 0.0 and 0.0 while the mean oedema scores (over 24, 48 and 72 hours) were 1.0, 0.0 and 0.0. The test substance is not considered to be irritating to the skin.
CAS 135800-37-2
A supporting skin irritation study similar to OECD guideline 404 (supporting study, 1990) was performed with Fatty acids, C8-16, 2- ethylhexyl esters (CAS 135800-37-2). The test substance was applied to the shaved skin of 4 rabbits under occlusive conditions for 4 hours of exposure. The local skin effects were scored 1, 24, 48 and 72 h, and 7 days after exposure ended. At the 24-hour reading time point 3/4 rabbits showed slight erythema (score 1), which persisted as slight erythema for 48 hours in 1/4 animals. At the 72-hour reading time point, slight to well-defined erythema was observed in 4/4 rabbits. The erythema had cleared completely within 7 days after the exposure ended. Oedema was observed in 1/4 animals 1 and 24 h after patch removal; the effect had cleared completely within 48 hours. The mean erythema scores (over 24, 48 and 72 hours) were 0.75, 0.25, 1.25, while the mean edema scores (over 24, 48 and 72 hours) were 0.25, 0, 0 and 0. The test substance is not considered to be irritating to the skin.
Eye irritation
CAS 17671-26-0
The eye irritation properties of Lauryl nonanoate were tested in a study according to OECD 492 and in compliance with GLP (key study, 2018). The EpiOcular™ cornea epithelial model was exposed to 50 μL of the neat/ undiluted test substance for 30 minutes and was incubated for another 2 hours after rinsing and removal of the test substance and 12 minutes of post-soak immersion.After treatment with the negative control the absorbance values were well within the required acceptability criterion of OD > 0.8 and < 2.5 thus showing the quality of the tissues. Treatment with the positive control induced a decrease below 50% compared with the negative control value in the relative absorbance thus ensuring the validity of the test system.The viability test (MTT) with the test substance revealed a mean tissue viability of 95% compared with the value of the negative control. Based on the obtained results, Lauryl nonanoate (CAS 17671-26-0) is not eye irritating.
Overall conclusion for skin and eye irritation
The available data on suitable source substances conclude that the source substances are not skin irritating. Therefore, the target substance Lauryl nonanoate is also not expected to be a skin irritant. No eye irritating potential was found for the target substance and is thus considered to be not an eye irritant.
Justification for classification or non-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.
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.