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EC number: 931-745-8 | CAS number: 1335203-21-8
- 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
Degree of irritation / corrosivity was variable and depended on the test substance lot and chemical impurities. In essence, the substance class is irritating to the skin and the eye.
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:
- 2001-06-07 to 2001-06-21
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Version / remarks:
- 1998
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Guideline 11 Nousan No. 6283 (October 1, 1999); First Revision: 12 Nousan 8628 (December 6, 2000)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: Young adult
- Weight at study initiation: 3329 to 3867 grams
- Housing: individual housing in suspended wire mesh cages
- Diet: 150 g/day, standard laboratory rabbit diet PMI Nutrition International, Inc. Certified Rabbit LabDiet® 5322
- Water: ad libitum, municipal water
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°F): 66-71
- Humidity (%): 50-75
- Air changes (per hr): no data
- Photoperiod: 12 hour light/dark cycle - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Each animal served as its one control with adjacent area of untreated skin.
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 ml
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- 4 h
- Observation period:
- 14 days
- Number of animals:
- 3
- Details on study design:
- PRE-EXPERIMENTAL PROCEDURE
On the day prior to dosing, the hair was removed from the backs and flanks of the rabbits using an electric clipper.
ADMINISTRATION OF THE TEST ARTICLE
Prior to use, the original container of the test article was agitated to insure a homogeneous mixture. A sufficient amount of test article was dispensed into a labeled storage vessel and a stir bar was added. The test article was stirred continuously throughout the dosing procedure. Each 0.5-ml was applied to an area of skin approximately 2.5 x 2.5 cm under a two-ply gauze patch secured in place with Micropore™ tape. The patches were overwrapped with a gauze binder and secured with Dermiform® tape. Plastic restraint collars were applied to the animals to prevent ingestion of the test article and/or bandages. The application sites were observed for erythema, edema and other dermal findings approximately 30-60 minutes and 24, 48 and 72 hours after patch removal and on study days 4, 7, 10 and 14.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 4 hours
At the end of four hours, the collars and bandages were removed and the sites wiped with disposable paper towels moistened with deionized water.
SCORING SYSTEM: Dermal irritation was graded in accordance with the method of Draize - Irritation parameter:
- erythema score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: Very slight erythema (score 1) in all animals at day 14
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritant / corrosive response data:
- CLINICAL SKIN OBSERVATIONS
- All animals were noted with moderate to severe erythema and very slight to slight edema. Focal eschar was noted for two animals on study day 7, and desquamation was noted for all animals on study days 7 through 14.
REVERSIBILITY
- Very slight erythema was still present for all animals at study termination (study day 14). - Other effects:
- TOXIC EFFECTS OTHER THAN SKIN IRRITATION
- There were no deaths during the study.
- Body weights: No remarkable body weight changes were noted during the study. - Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- Interpretation is based on erythema/eschar and edema calculated as mean scores for each animal following grading at 24, 48 and 72 hours after removal of the test material, in consideration of reversibility. The following mean scores were calculated for oleic-acid based IQAC, DMS quaternised: erythema 3/3/3 and edema 1/1.33/1.67. Edema were fully reversible within 14 days in all animals, whereas very slight erythema (score 1) was still present in all animals at study termination (day 14).
- Executive summary:
In a primary skin irritation study according to US Guideline EPA OPPTS 870.2500 (1998), OECD Guideline 404 (1992), EU Guideline B.4 (1992) and Japanese Guideline Nousan No. 6283 (1999), revised Nousan 8628 (2000), three White New Zealand rabbits were semi-occlusive dermally exposed to 0.5 ml of oleic-acid based IQAC, DMS quaternised (according to sponsor information: 80 % of CAS No. 72749-55-4, 15 % of CAS No. 9004-96-0 (Oleic acid, ethoxylated) and 5 % of CAS No. 25322-68-3 (Poly(oxy-1,2-ethanediyl),α-hydro-ω-hydroxy- Ethane-1,2-diol, ethoxylated)) for 4 hours. Animals then were observed for 14 days. Irritation was scored by the method of Draize.
The oleic-acid based IQAC, DMS quaternised induced in all animals moderate to severe erythema and very slight to slight edema. Focal eschar was noted for two animals on study day 7, and desquamation was noted for all animals on study days 7 through 14. Very slight to slight erythema was still present for all animals at study termination (study day 14). Mean scores from gradings at 24, 48 and 72 hours after removal of the test material for erythema were for all animals >/=2.3 but < 4. Edema were less severe. Inflammation persisted to the end of the observation period (14 days) in all three animals.
Reference
Irritant/corrosive response data for each animal at each observation time
Score at time point |
Erythema |
Edema |
Max. score: 4 |
Max. score: 4 |
|
0.5-1 hour |
3/2/2 |
1/1/1 |
24 hours |
3/3/3 |
1/2/2 |
48 hours |
3/3/3 |
1/1/2 |
72 hours |
3/3/3 |
1/1/1 |
4 days |
3/3/3 |
1/1/1 |
7 days |
2d/2dg/3dg |
1/1/1 |
10 days |
2d/2d/2d |
0/0/1 |
14 days |
1d/1d/1d |
0/0/0 |
d=desquamation; g = focal eschar
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (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:
- 2001-06-14 to 2001-07-08
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Version / remarks:
- 1998
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Guideline 11 Nousan No. 6283 (October 1, 1999); First Revision: 12 Nousan 8628 (December 6, 2000)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Covance Research Products Inc. Denver, PA, USA
- Age at study initiation: Young adult
- Weight at study initiation: 2577 to 2758 grams
- Housing: individual housing in suspended wire mesh cages
- Diet: 150 g/day, standard laboratory rabbit diet PMI Nutrition International, Inc. Certified Rabbit LabDiet® 5322
- Water: ad libitum, municipal water
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°F): 66-77
- Humidity (%): 48-80
- Air changes (per hr): no data
- Photoperiod: 12 hour light/dark cycle - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Each animal served as its one control. The test article was introduced into the conjunctival sac of one eye, the untreated eye serving as a control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 ml
- Concentration: The test article was applied unchanged as received - Duration of treatment / exposure:
- Eyes were not rinsed after treatment.
- Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: no washing was done
SCORING SYSTEM: in accordance with Draize, as published in the guidelines in Subsection F. Hazard Evaluation: Human and Domestic Animals distributed in 1984 and the EPA-OPPTS Health Effects Test Guidelines (1998).
TOOL USED TO ASSESS SCORE: A direct ophthalmoscope was used during these observations to examine the corneal tissue. In addition, both eyes were further examined at 24 hours and at all subsequent observations with sodium fluorescein.
PREPARATION and SELECTION of ANIMALS: Both eyes of all rabbits were examined for ocular abnormalities prior to initiation of dosing. The pre-initiation examination included the use of sodium fluorescein and a direct ophthalmoscope for detection of corneal abnormalities. Only rabbits with no
pre-existing ocular abnormalities were assigned to study.
Both eyes of all rabbits were examined macroscopically for ocular irritation in accordance with the method of Draize at approx. 1, 24, 48, 72 h, 4, 7, 14 d - Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- other: #1, #2
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: day 14
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: day 21
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 17 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1, #2
- Time point:
- 24/48/72 h
- Score:
- 3.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 17 days
- Irritant / corrosive response data:
- Positive corneal, iridal and conjunctival findings were noted for all animals. Corneal neovascularization was noted for two animals on study days 7 through 14 or 17. Iridal irritation subsided by study day 7, and corneal and conjunctival irritation completely subsided by study termination (study day 21).
The Maximum Average Score for the test substance was 50.3 at 48 hours post-instillation. - Other effects:
- There were no deaths or remarkable body weight changes during the study period.
- Interpretation of results:
- Category 2A (irritating to eyes) based on GHS criteria
- Conclusions:
- Interpretation is based on effects on the cornea, iris and conjunctiva calculated as mean scores following grading at 24, 48 and 72 hours after instillation of the test material, in consideration of reversibility. Slight to moderate effects of cornea and iris were observed and moderate to severe conjunctivae and chemosis scores. All symptoms were fully reversible within 21 days.
- Executive summary:
In a primary eye irritation study according to US Guideline EPA OPPTS 870.2400 (1998), OECD Guideline 405 (1987), EU Guideline B.5 (1992) and Japanese Guideline Nousan No. 6283 (1999), revised Nousan 8628 (2000), 0.1 ml of oleic-acid based IQAC, DMS quaternised (according to sponsors information: 80 % of CAS No. 72749-55-4, 15 % of CAS No. 9004-96-0 (Oleic acid, ethoxylated) and 5 % of CAS No. 25322-68-3 (Poly(oxy-1,2-ethanediyl),α-hydro-ω-hydroxy- Ethane-1,2-diol, ethoxylated)) was instilled into the conjunctival sac of three White New Zealand rabbits. The eyes were not rinsed after substance application. Animals then were observed for 21 days. Irritation was scored by the method of Draize.
Positive corneal, iridal and conjunctival findings were noted for all animals. Corneal neovascularization was noted for two animals on study days 7 through 14 or 17. Iridal irritation subsided by study day 7, and corneal and conjunctival irritation completely subsided by study termination (study day 21).
The test substance induced a maximum mean total score of 50.3 (maximum possible mean total score of 110) at 48 hours post-instillation. Mean scores following grading at 24, 48 and 72 hours after instillation of the test material for corneal opacity were >/= 1but < 3, for iritis >/= 1 but < 1.5 and for conjunctival redness and oedema >/= 2. All effects were completely reversible in all animals within 21 days.
Reference
Irritant/corrosive response data for each animal at each observation time
Score at time point / Reversibility |
Cornea opacity |
Cornea - Area involved |
Iris |
Conjunctivae Redness |
Conjunctivae Chemosis |
Conjunctivae Discharge |
Fluorescein test (% of cornea retaining stain) |
Max. score: 4 |
Max. score: 4 |
Max. score: 2 |
Max. score: 3 |
Max. score: 4 |
Max. score: 3 |
Max.: 100 % |
|
1 hour |
1/1/1 |
1/1/1 |
1/1/1 |
2/2/1 |
3/2/3 |
3b/3b/3b |
no |
24 hours |
1/1/1 |
4/4/1 |
1/1/0 |
3/2/2 |
4/3/3 |
3b,p/3b,p/3b,p |
yes 75/65/10 |
48 hours |
2/2/1 |
4/4/1 |
1/1/0 |
3/3/2 |
4/4/3 |
3b,p/3b/3b,p |
yes 65/45/5 |
72 hours |
2/2/1 |
4/3/1 |
1/1/0 |
3/2/2 |
3/4/2 |
3b,p/3b/1b,p |
yes 50/30/0 |
4 days |
2/2/1 |
4/3/1 |
1/1/0 |
3/2/2 |
3/3/2 |
2b,p/2b/1b,p |
yes 50/20/0 |
7 days |
2k/1k/0 |
2/1/0 |
0/0/0 |
2/2/1 |
2/2/1 |
1b/0/0 |
yes 15/5/0 |
10 days |
1k/1k/0 |
1/1/0 |
0/0/0 |
1/2/1 |
1/1/1 |
0/0/0 |
yes 0/0/0 |
14 days |
1k/1k/0 |
1/1/0 |
0/0/0 |
1/1/0 |
0/1/0 |
0/0/0 |
yes 0/0/0 |
17 days* |
0/1k/- |
0/1/- |
0/0/- |
0/1/- |
0/0/- |
0/0/- |
yes 0/0/- |
21days** |
-/0/- |
-/0/- |
-/0/- |
-/0/- |
-/0/- |
-/0/- |
yes -/0/- |
* only the two animals with responses at 14 days examined
** only the animal with responses at 17 days examined
b = clear discharge, p = purulent discharge in conjunctival sac, k = corneal neovascularization
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The degree of irritation / corrosivity was variable and most likely depends on undeclared chemical impurities in some of the test substances.
For the eye effects of an oleic-acid based IQAC, DMS quaternised, with by-products of approx. 10 % of nonylphenol ethoxilate, 1 % of free amine and 0.5 % of hydrogen peroxide, the corrosive effects can be attributed to the alkyl phenol, which causes severe damage to eyes. Though this substance contains the highest content of IQACs tested, its eye damaging potential is untypical for the substance class and can be rationalised as being due to its by-products.
Studies performed according to US Federal Hazardous Substances Act (FHSA) pointing to skin corrosion and serious eye damage had significant deficiencies in methodology regarding time of exposure, post-exposure observation time and reporting and are therefore not regarded as reliable data. In essence, the substance class is irritating to skin and eyes.
Justification for selection of skin irritation / corrosion endpoint:
Data from a GLP compliant study with reliability 1, according to acutal guidelines.
Justification for selection of eye irritation endpoint:
Data from a GLP compliant study with reliability 1, according to acutal guidelines.
Effects on skin irritation/corrosion: irritating
Effects on eye irritation: irritating
Justification for classification or non-classification
Skin irritation: Cat. 2 according to GHS/CLP; R38, Irritating to Skin according to Directive 67/548/EEC
Eye irritation: Cat. 2 according to GHS/CLP; R36, Irritating to Eyes according to Directive 67/548/EEC
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.