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EC number: 286-304-6 | CAS number: 85204-10-0
- 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
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well documented and reported study fully adequate for assessment. The study was conducted according to internationally accepted technical guidelines and in compliance with GLP in a recognized contract research organization.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- 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: Charles River Deutschland GmbH, D-97633 Sulzfeld.
- Age at study initiation: not stated
- Weight at study initiation: 2,0-2,3 kg
- Housing: individual caging in metal wire cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 -12 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): average of 19
- Humidity (%): average of 48.8
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light):12/12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0,5mL
- Concentration (if solution): neat test material - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3 animals
- Details on study design:
- TEST SITE
- Area of exposure: medianon the dorsal thoracal region, 2.5 cm x 2.5 cm
- Type of wrap if used: Pur Zellin-Tupfer
SCORING SYSTEM:
Erythema I Eschar formation
0 No erythema.
1 Very slight erythema (barely perceptible).
2 Well-defined erythema.
3 Moderate to severe erythema.
4 Severe erythema (beet redness) or eschar formation (injuries in depth).
Oedema formation
0 No oedema.
1 Very slight oedema (barely perceptible).
2 Slight oedema (edges of area weil defined by definite raising).
3 Moderate oedema (raised approximately 1 mm).
4 Severe oedema (raised more than 1 mm and extending beyend area of exposure). - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- erythema score
- Basis:
- animal: 2 and 3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- edema score
- Basis:
- animal: 2 and 3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Interpretation of results:
- other: not irritating according to Regulation 1272/2008
Reference
No symptoms of systemic toxicity were observed in the animals during the test period and no mortalitiy occured.
All areas to be treated with the test substance and all control areas were normal before the application.The control areas were normal at any observation time.
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study was conducted according to internationally accepted technical guidelines and in compliance with GLP in a recognized contract research organization. The study is scientifically valid and the report is fully adequate for assessment, despite some apparent typing errors regarding the grading of ocular findings.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- of 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- of 2004
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Number and Sex: 3 males
- Animal supplier: Charles River Deutschland GmbH, D-97633 Sulzfeld, Germany
- Weight at study start or test start*: Minimum 1.9 kg, maximum 2.4 kg
- Hygiene: Optimal hygienic conditions
- Housing: Individual housing in metal wire cages from Ehret GmbH, D-79312 Emmendingen,
cage type KK 016R, 79 cm x 59 cm bottom area, 38 cm height
- Environmental enrichment: Aspen wood blocks
- Diet (ad libitum): Altromin 2123 maintenance diet for rabbits, rich in crude fiber, Altromin, D-32791 Lage, Germany
In addition, dietary supplement of hay-briquettes from SSNIFF, D-59494 Soest, Germany
- Water(ad libitum): Tap water from an automatic watering system
- Acclimation period: 5 days (animal #1), 12 days (animals #2 & #3).
Analysis of the diet for ingredients and contaminants has been performed randomly by the supplier (Altromin, D-32791 Lage, Germany)
* The study report does not clearly specify whether "study or test start" refers to prior to dosing on the day of instillation.
ENVIRONMENTAL CONDITIONS
Air conditioned animal room set at:
- Temperature (°C): Room temperature, average of 19.2°C (continuous control and recording)
- Relative Humidity (%): Average of 48.4 % (continuous control and recording)
- Photoperiod (artificial lighting): 12 hrs day / 12 hrs night
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1 mL of undiluted liquid test material was administered into the conjunctival sac of one eye per rabbit (right eye). The contralateral eye (left eye) remained untreated to serve as a control.
- Duration of treatment / exposure:
- Rinsing of the eyes after treatment has not been mentioned in the report. Therefore it is assumed that, the treatment/exposure period was equivalent to the entire observation period following instillation or lasted until removal of the test material by physiological mechanisms, whichever happened sooner.
- Observation period (in vivo):
- up to 21 days (ending individually for each animal, when the animal was free of alterations)
- Number of animals or in vitro replicates:
- 3 male rabbits
- Details on study design:
- EYE EVALUATION:
Within 24 hours before treatment start, both eyes of each animal were investigated to ensure that there was no pre-existing corneal damage, iridial inflammation or conjunctival irritation.
One animal was initially treated and, in the absence of a severe effect (no corrosive effect) until 72 hours post instillation, the remaining two animals were committed to the study.
Eyes were evaluated in all animals at approximately 1, 24, 48 and 72 hours after test substance instillation adopting the numerical scoring system listed in Table 1 in the field below. Additional examinations were performed 7, 14 and/or 21 days after the instillation (ending individually for each animal, by the observation time point the animal was entirely free from alterations). Grades attained at 24, 48 and 72 hours after instillation were included in the mean gradings of ocular lesions and used for evaluation of the necessity of eye irritation/corrosion classification. As from 24 h after test substance instillation, staining with fluorescein (Minims Fluorescein Sodium 2 %) supported the recognition of corneal lesions in all animals.
Equipment used for eye evaluation: Otoscope lamp - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- over 3 animals and 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- , as in one animal (# 2) corneal opacity grade 2 followed at 7, 14 & 21 days after instillation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- mean over 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- mean over 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- , as corneal opacity grade 2 followed at 7, 14 & 21 days after instillation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- mean over 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- over 3 animals and 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- mean over 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: Iridic changes were not evident
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- mean over 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: Iridic changes were not evident
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- mean over 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Remarks:
- over 3 animals and 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 1.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Remarks:
- mean over 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Remarks:
- mean over 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Remarks:
- mean over 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- over 3 animals and 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 3.6
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days in one (#2) of three animals
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- mean over 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 3.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- mean over 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 3.7
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days, but clear trend to reversibility as on Days 14 & 21 only grade 1
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- mean over 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 3.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- other: Discharge
- Basis:
- mean
- Remarks:
- over 3 animals and 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 1.2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- other: Discharge
- Basis:
- animal #1
- Remarks:
- mean over 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- other: Discharge
- Basis:
- animal #2
- Remarks:
- mean over 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- other: Discharge
- Basis:
- animal #3
- Remarks:
- mean over 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- Iridic lesions were not evident throughout the study, except for one incidence of a grade 1 lesion in male #3 at 24 hours after test material instillation (Day 1). Corneal lesions (opacity grade 1) were seen in all animals at 24, 48 and 72 hours after instillation and by Day 7 had entirely disappeared in two animals (#1 and #3), whereas irreversibly had increased in severity to grade 2 in the other animal (#2). Staining with fluorescein solution revealed damage of the anterior corneal epithelium. Although, severity grade-2 corneal opacity remained in animal #2 until Day 21, the affected corneal area gradually decreased from grade 4 on Day 1 to grade 2 on Days 7, 14 and 21. In addition to the findings specified under "Overall irritation/corrosion results", conjunctival redness grade 1 or 2, chemosis grade 2 or 4 and discharge grade 1, 2 or 3, were also seen at 1 h after instillation and, except for chemosis, were fully reversible in all animals. Chemosis was fully reversible in animals #1 and #3, whereas in animal #2 still evident as grade 1 by Day 21. Control eyes (untreated) were without ocular findings throughout the observation period.
- Other effects:
- Mortality or signs of systemic toxicity were not evident and bodyweight was unaffected by treatment with the test material.
- Interpretation of results:
- other: Category 1 (irreversible effects on the eye) according to Regulation 1272/2008
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Effects on eye irritation: corrosive
Justification for classification or non-classification
There were only slight and reversible effects of skin irritation in one animal, and no effects in the other two animals. The result of this in vivo test does not necessitate any classification and labelling regarding skin irritation according to REGULATION (EC) 1272/2008.
The irreversible corneal lesions in one animal in the in vivo eye irritation study necessitate classification of WS400402 as “Category 1 (irreversible effects on the eye)" [REGULATION (EC) 1272/2008].
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