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EC number: 500-336-2 | CAS number: 157348-58-8
- 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
The test item showed no irritant effects on the skin of female rabbits in a study according to an OECD 404 (LPT, 2016). The test item causes irreversible damage to eyes in a study according to OECD 405 in male rabbits (LPT, 2016).
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:
- 2016-03-08 to 2016-03-29
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted July 28, 2015
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 2008
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS:
- Source: Manfred Bauer Kaninchen, Lohe 7/1, 74632 Neuenstein, Germany
- Sex: female
- Age: approx.4 months
- Weight at study initiation: 3.7 kg - 4.3 kg
- Housing: single
- Diet: ad libitum, Commercial diet, ssniff® K-H V2333 (ssniff Spezialdiäten GmbH, 59494 Soest, Germany)
- Water: ad libitum, tap water
- Acclimatisation period: at least 20 days
- Controls: untreated skin surrounding the application area
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C +/- 3 °C
- Humidity (%): 30% - 70%
- Photoperiod (hrs dark / hrs light): 12 hour light/12 hour dark cycle
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.5 ml test item/patch and animal
- Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- Postexposure period: 72 hours (Because no effects have been observed the period of observation is not 14 days but 72 hours.)
- Number of animals:
- 3
- Details on study design:
- ADMINISTRATION/EXPOSURE
- Preparation of test substance: unchanged
- Area of exposure: dorsal area of trunk, shaved 24 hours in advance, approx. 6 cm2
- Concentration: 0.5 mL of the test item was applied to the test site (area: approx. 6 cm2).
- Occlusion: gauze patch held in place by semi-occlusive non-irritating tape dressing
- Inital test:
Three test patches were applied sequentially to the animal. The first patch was removed after three minutes
As no serious skin reaction was observed, a second patch was applied at a different site and removed after one hour.
No skin reactions were observed, neither. So a third patch was applied and removed after 4 hours.
After the end of exposure time, no residual test item had to be removed.
- Confirmatory test:
As no skin reactions were observed in the initial test, the test was completed using two additional animals, each with one patch only, for an exposure period of 4 hours.
- Washing: at the end of the exposure time no residual test item had to be removed.
EXAMINATIONS
- After the 4-hour exposure period the patch was removed and the skin sites were evaluated.
- Examination time points: 60 minutes, 24, 48, 72 hours,
- Scoring system: Draize (0-4 possible scores each for erythema/eschar and for edema) - Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 1, 24, 48, 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- AVERAGE SCORE
- Erythema: 0
- Edema: 0 - Other effects:
- no other effects
- Conclusions:
- According to the study, the test item showed no irritant effects on the skin of female rabbits.
- Executive summary:
The purpose of this study was to examine the test item for acute dermal irritation/corrosion properties in rabbits (patch test).
Under the present test conditions, none of three rabbits exposed for 4 hours to 0.5 mL test item/patch (semi-occlusive conditions) revealed any skin reaction.
There were no systemic intolerance reactions.
Reference
Findings Examination Skin irritation scores
of the skin schedule
animal no.
1 2 3
E/Oe E/Oe E/Oe
500 mL substance/patch/animal
erythema and
eschar formations/ before dosing 0/0 0/0 0/0
oedema formation
time after removal after 3 -minute appl (patch 1) 0/0
after 1 hour appl (patch 2) 0/0
after 4 hour exp (patch 3) 0/0
of the patch
(4-hour exposure) patch 3 patch 1 patch 1
60 min 0/0 0/0 0/0
24 hours 0/0 0/0 0/0
48 hours 0/0 0/0 0/0
72 hours 0/0 0/0 0/0
0 no pathological findings
E erythema and eschar formations
Oe oedema
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:
- 2016-05-26 to 2016-06-07
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted October 02, 2012
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- adopted May 30, 2008
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS:
- Species / Strain: Rabbit / New Zealand White
- Source: Manfred Bauer Kaninchen, Lohe 7/1, 74632 Neuenstein, Germany
- Sex: male
- Age: Approx. 3 months
- Weight at study initiation: Animal no. 1: 2.6 kg
- Housing: single
- Diet: ad libitum, Commercial diet, ssniff® K-H V2333 (ssniff Spezialdiäten GmbH, 59494 Soest, Germany,
- Water: ad libitum, tap water
- Acclimatisation period: at least 20 days
- Controls: identical animal, second eye
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C +/- 3 °C
- Humidity (%): 30% - 70%
- Photoperiod (hrs dark / hrs light): 12 hour light/12 hour dark cycle
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: identical animal, left eye
- Amount / concentration applied:
- Amount: 0.1 mL of the test item was administered to the right eye of one animal.
- Duration of treatment / exposure:
- Single administration into the conjunctival sac of the right eye
- Observation period (in vivo):
- 24 hours
- Number of animals or in vitro replicates:
- 1 male rabbit
- Details on study design:
- ADMINISTRATION:
The test was performed initially using one animal. Due to the severe findings on cornea, iris and conjunctiva the test was stopped 24 hours after instillation. No further animal was employed.
0.1 mL of the test item was administered to the right eye of one animal.
The test item was placed into the conjunctival sac of the right eye of the animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second in order to prevent loss of the material.
The left eye, which remained untreated, served as a control.
REMOVAL OF TEST SUBSTANCE
- Washing: test item was not rinsed
SCORING SYSTEM: Draize scale
TOOL USED TO ASSESS SCORE:
The eyes were examined ophthalmoscopically with a slit lamp prior to the administration and 1 and 24 hours after the administration.
The eye reactions were observed and registered.
One day before and 24 hours after administration, fluorescein was applied to the eyes before being examined to aid evaluation of the cornea for possible lesions. - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 4
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24 h
- Max. score:
- 2
- Remarks on result:
- other: not evaluable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 4
- Max. score:
- 4
- Irritant / corrosive response data:
- SCORE
- Cornea: 4
- Iris: not evaluable - no examination
- Conjunctivae (Redness): 2
- Conjunctivae (Chemosis): 4 - Other effects:
- no other effects
- Conclusions:
- The test substance causes irreversible damage to eyes in a study according to OECD 405 in rabbits.
- Executive summary:
The purpose of this study was to obtain information on the influence of test item on rabbit eyes (irritation/corrosion test).
Under the present test conditions, a single instillation of 0.1 mL test item into the conjunctival sac of the right eye of one rabbit caused the following effects:
Corneal opacity was observed at 60 minutes (grade 3) and 24 hours (grade 4) after instillation.
The fluorescein test revealed corneal staining (whole surface) 24 hours after instillation.
Iridial response was not evaluable.
Conjunctival redness was observed at 60 minutes (grade 3) and 24 hours (grade 2) after instillation.
Chemosis was observed at 60 minutes (grade 3) and 24 hours (grade 4) after instillation.
As lesions such as a grade 4 corneal opacity are generally not reversible, the study was stopped 24 hours after instillation and the animal was humanely killed.
Reference
Examination of the treated eye
Time after administration |
C O R N E A |
I R I S |
C O N J U N C T I V A E |
F L U O R E S C E I N T E S T |
||
|
Opacity |
|
Redness#1 |
Chemosis#2 |
Grade |
Area |
|
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|
|
|
|
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A n i m a l n o. : 1 |
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|
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right eye: 0.1 mLTest item/animal |
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|
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|
|
before dosing |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
|
|
|
|
|
60 minutes |
3 |
#3 |
3 |
3 |
- |
- |
|
|
|
|
|
|
|
24 hours |
4 |
#3 |
2 |
4 |
4 |
4 |
|
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|
|
#1 refers to palpebral and bulbar conjunctivae; excluding cornea and iris
#2 swelling: refers to lids and/or nictitating membrane
#3 not evaluable
- no examination
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Based on the available data the test item is not irritating to skin and therefore must not be classified according to criteria of EC Regulation 1272/2008.
Based on the available data the test substance causes irreversible damage to eyes and hence according to criteria of EC Regulation 1272/2008 the test substance is classified as eye damage Cat. 1; H318 "Causes serious eye damage".
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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