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EC number: 916-222-4 | 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
Skin Irritation: rabbit; key; kl2; (3% solution): not irritating
Human volunteer patch test (supporting) (1% solution): not irritating
Eye Irritation rabbit; WoE2; kl2; (3% solution): not irritating
rabbit; WoE1; kl3 (100% substance): corrosive
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:
- April 1999
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Type of coverage:
- occlusive
- Preparation of test site:
- other: two sites (both clipped), one unabrated skin and one abrated skin
- Vehicle:
- not specified
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5ml
- Concentration (if solution): 3 % solution - Duration of treatment / exposure:
- 4h
- Observation period:
- 24h and 72h
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: one square inch
- % coverage: not specified
- Type of wrap if used: plastic weap secured with adhesive tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not specified, reported that excess materal was removed from the site.
- Time after start of exposure: 4h
OBSERVATION TIME POINTS
(indicate if minutes, hours or days) 24h and 72h
SCORING SYSTEM:
- Method of calculation: Draize scoring system - Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0.25
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Stepanquat ML 3% solution was applied on the skin of rabbits. The primary dermal irritation score was calculated to be 0.25 indicating that the test substance is not a skin irritant.
Reference
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:
- weight of evidence
- Study period:
- May 1958
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- significant methodological deficiencies
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- 0.1 ml of a test item solution was instillated into the eyes of each of three albino rabbits. The right eye remained unwashed and the left eyes were irrigated with water for 20s after the instillation of the material. With the aid of fluorescein staining and a hand-slit-lamp, the eyes were examined one hour, four hours and 24 hours after treatment, and where possible daily after, until the animals were sacrificed. Microscopic examination of corneas were also carried out.
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- other: albino
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 0.1ml 100% test substance, 10% test substance, 1.5% test substance
- Duration of treatment / exposure:
- 20s
- Observation period (in vivo):
- 24 hours (min) - 23 days (max)
- Irritation parameter:
- conjunctivae score
- Basis:
- other: 100%
- Time point:
- 24 h
- Reversibility:
- not fully reversible within: 22 days
- Remarks on result:
- probability of severe irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- other: 100%
- Time point:
- 24 h
- Remarks on result:
- probability of severe irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- other: 10 %
- Time point:
- 24 h
- Reversibility:
- fully reversible within: 3 days
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- other: 1.5%
- Time point:
- 24 h
- Reversibility:
- fully reversible within: 72h
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Undiluted test substance caused corneal damage when instilled into the eyes of rabbits
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin Irritation
In the skin irritation study the test item 3% (0.5ml) was applied in two sites, one unabrated skin and one abrated skin, approximately 1 square inch each of three albino rabbits. The application site were covered with a two layer gauze patch secured with non-irritating porous adhesive tape and the entire site was covered with 4 mil palstic wrap and secured with more adhesive tape. At the end of the 4 hour contact period excess material was remoed from the sites. Dermal irritation observations were performed at 24 and 72 hours after the test materail was applied to the sites. Grading and scoring was done according to the Draize. Primary irritation score was calculated to be 0.25 indicating that Stepanquat ML 3% is not a skin irritant.
In the human patch test 206 volunteers were exposed to test substance (1%). Cloth containg Avitex R and untreated cloth were used as a controls. Patched of one-inch square were applied to the arms of 97 men and to the arms of 109 women and held in place for six days. Following a ten days period, new patches of the same material were applied and removed after 28 hours. The skin under patched were was examined 24hours and six days after initial application. Irritation which could be attributed to the test materials was not observed at any of the examination, indicating that neither primary irritation nor allergic contact dermatitis had resulted in any of the 206 subjects.
Eye Irritation
In the eye irritation study the test item (Stepanquat ML 3%) was administered into one eye of each of three albino rabbits. The eyes were observed and scored at 24, 48 and 72 hours. Instilliation of the sample into the eyes of rabbits produced no positive eye irritating reactions in any of the three test subjects indicating that Stepanquat ML 3% in not a eye irritant.
In the other study 0.1 ml of a 100%,10% and 1.5% test item was instillated into the eyes of each of three albino rabbits. The right eye remained unwashed and the left eyes were irrigated with water for 20s after the instillation of the material. With the aid of fluorescein staining and a hand-slit-lamp, the eyes were examined one hour, four hours and 24 hours after treatment, and where possible daily after, until the animals were sacrificed. Microscopic examination of corneas were also carried out. Undiluted test substance caused corneal damage when instilled into the eyes of rabbits. At concentration 10% and 1.5% it did not corneal damage but did cause mild conjuctival irritation.
Justification for classification or non-classification
Stepanquat ML is classified for skin irritant Cat 2 according to CLP Regulation 1272/2008. This conclusion is made (as worst case scenrio) as no skin irritation studies are not conducted for the substance and the substance has been shown to be damaging to the eyes.
WoE analysis indicate that Stepanquat ML need to be classified for eye dam Cat 1 according to CLP Regulation 1272/2008.
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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