Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 208-798-4 | CAS number: 542-08-5
- 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 skin irritation potential in an in vivo study in rabbits (reference 7.3.1-1).
The test item showed eye irritating properties in an in vivo study in rabbits (reference 7.3.2-1).
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:
- 1988-01-12 to 1988-01-15
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 1984-04-25
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1981-05-12
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: HOECHST AG
- Age at study initiation: ca. 3-5 months
- Weight at study initiation: 2.7 - 3.0 kg
- Housing: individual cages
- Diet: ad libitum, rabbit diet Altromin 2123 and hay
- Water: ad libitum, deionised and chlorinated water
- Acclimation period: not detailed
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 50 ± 20
- Air changes (per hr): not detailed, but air condition in animal rooms
- 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 applied: 0.5 mL - Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm area covered with a band aid, in a ca. 25 cm² clipped area on the dorsal trunk of each rabbit
- Type of wrap: band aid covered with a semiocclusive bandage
REMOVAL OF TEST SUBSTANCE
- Washing: yes, with lukewarm tap water
- Time after start of exposure: after exposure time of 4 h
OBSERVATION TIME POINTS
30 minutes and 1, 24, 48 and 72 h after exposure
SCORING SYSTEM:
Erythema and eschar formation:
0: no erythema
1: slight, barely perceivable, erythema
2: well-defined erythema
3: mild to severe erythema
4: severe erythema (intense redness) to formation of eschar (penetrative injury)
Edema formation:
0: no edema
1: slight, barely perceivable, edema
2: slight edema (with swelling at well-defined boundary)
3. mild edema (swelling ca. 1 mm)
4. severe edema (swelling of more than 1 mm and larger than exposure area) - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No effect observed.
- Other effects:
- No further effects were observed.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item showed no skin irritation potential in a in vivo study in rabbits.
- Executive summary:
The skin irriation potential of the test item was evaluated using an in vivo study according to OECD 404 in three rabbits. The undiluted test item was applied to a clipped area on the dorsal trunk of the animals under semiocclusive cover. The exposure time was 4 hours. Afterwards residual test item was removed by washing with lukewarm water. The test site was evaluated after 30 minutes and 1, 24, 48 and 72 hours. The animals showed a mean erythema score for 24/48/72 h of 0.9 with no individual animal scoring higher than 1.0. The mean edema score for 24/48/72 h was 0.1 with the mean score for one animal at 0.3 and 0.0 for the remaining two animals. All effects observed were reversible within 72 h. Based on the results of the in vivo study in rabbits the test item was determined not to cause skin irritation or corrosion.
Reference
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:
- 1988-01-19 to 1988-01-26
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- 1984-01-25
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1987-02-24
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: HOECHST AG
- Age at study initiation: ca 3 - 5 months
- Weight at study initiation: 2.1 - 3.2 kg
- Housing: single
- Diet: ad libitum, rabbit diet Altromin 2123 and hay
- Water: ad libitum, deionised and chlorinated water
- Acclimation period: not detailed
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 50 ± 20
- Air changes (per hr): not detailed, but air condition in animal rooms
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 mL - Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: with ohysiological saline at ca. 37 °C
- Time after start of exposure: after 24 h and for each evaluation if discharge was observed, and after treatment with fluorescein solution (0.01 %)
SCORING SYSTEM:
Cornea
Opacity: degree of density (readings should be taken from most dense area)
0: No ulceration or opacity
1: Scattered or diffuse areas of opacity (other than slight dulling of normal lustre); details of iris clearly visible
2: Easily discernible translucent area; details of iris slightly obscured
3: Nacrous area; no details of iris visible; size of pupil barely discernible
4: Opaque cornea; iris not discernible through the opacity
Iris
0: Normal
1: Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia; or injection; iris reactive to light (a sluggish reaction is considered to be an effect)
2: Hemorrhage, gross destruction, or no reaction to light (all or one of the symptoms)
Conjunctivae
Redness: lids and/or nictating membranes
0: Normal
1: Some blood vessels hyperaemic (injected)
2: Diffuse,crimson colour; individual vessels not easily discernible
3: Diffuse beefy red
Chemosis
Swelling: lids and/or nictating membranes
0: Normal
1: Some swelling above normal (incl. nictating membranes)
2: Obvious swelling, with partial eversion of lids
3: Swelling, with lids about half closed
4: Swelling, with lids more than half closed
TOOL USED TO ASSESS SCORE: fluorescein - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No effect observed
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: No effect observed
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritant / corrosive response data:
- The conjunctivae showed very slight swelling to swelling with lids about half closed from one to 24 hours after treatment. In addition it was crimson coloured to beefy red and the iris was redden and a diffuse opacity of the cornea was detected. 48 hours after application effects reached from some hyperaemic blood vessels to diffuse,crimson colour of the conjunctivae. One animal presented with a barely perceivable swelling of the conjunctivae. In two animals some hyperaemic blood vessels could still be observed 72 hours after treatment. Within the first 24 hours clear, colourless discharge accompanied some of the observed effects. At the examination 7 days after treatment no effects were detected.
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- The test item showed eye irritating properties in rabbits.
- Executive summary:
In a study according to OECD 405 the potential of the test item to induce eye irritation or corrosion was determined. Therefore, the test item was instiled into each one eye of three rabbits. The other eye was used as untreated control. After 24 h the eye was rinsed and the effects were evaluated after 1, 24, 48 and 72 hours and after 7 days. The conjunctivae showed very slight swelling to swelling with lids about half closed from one to 24 hours after treatment. In addition it was crimson coloured to beefy red and the iris was redden and a diffuse opacity of the cornea was detected. 48 hours after application effects reached from some hyperaemic blood vessels to diffuse,crimson colour of the conjunctivae. One animal presented with a barely perceivable swelling of the conjunctivae. In two animals some hyperaemic blood vessels could still be observed 72 hours after treatment. Within the first 24 hours clear, colourless discharge accompanied some of the observed effects. At the examination 7 days after treatment no effects were detected. Based on two animals showing a conjunctivae score of 2.0 for 24/48/72 h the test item is considered to cause eye irritation.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
The skin irritation potential of the test item was evaluated using an in vivo study according to OECD 404 in three rabbits. The undiluted test item was applied to a clipped area on the dorsal trunk of the animals under semiocclusive cover. The exposure time was 4 hours. Afterwards residual test item was removed by washing with lukewarm water. The test site was evaluated after 30 minutes and 1, 24, 48 and 72 hours. The animals showed a mean erythema score for 24/48/72 h of 0.9 with no individual animal scoring higher than 1.0. The mean edema score for 24/48/72 h was 0.1 with the mean score for one animal at 0.3 and 0.0 for the remaining two animals. All effects observed were reversible within 72 h. Based on the results of the in vivo study in rabbits the test item was determined not to cause skin irritation or corrosion.
Eye irritation
In a study according to OECD 405 the potential of the test item to induce eye irritation or corrosion was determined. Therefore, the test item was instiled into each one eye of three rabbits. The other eye was used as untreated control. After 24 h the eye was rinsed and the effects were evaluated after 1, 24, 48 and 72 hours and after 7 days. The conjunctivae showed very slight swelling to swelling with lids about half closed from one to 24 hours after treatment. In addition it was crimson coloured to beefy red and the iris was redden and a diffuse opacity of the cornea was detected. 48 hours after application effects reached from some hyperaemic blood vessels to diffuse, crimson colour of the conjunctivae. One animal presented with a barely perceivable swelling of the conjunctivae. In two animals some hyperaemic blood vessels could still be observed 72 hours after treatment. Within the first 24 hours clear, colourless discharge accompanied some of the observed effects. At the examination 7 days after treatment no effects were detected. Based on two animals showing a conjunctivae score of 2.0 for 24/48/72 h the test item is considered to cause eye irritation.
Justification for classification or non-classification
Classification,
Labelling, and Packaging Regulation (EC) No 1272/2008
The
available experimental test data are reliable and suitable for
classification purposes under Regulation (EC) No 1272/2008. Based on
available data on skin irritation, the test item does not require
classification for skin irritation according to Regulation (EC) No
1272/2008 (CLP), as
amended for the fifteenth time in Regulation (EU) 2020/1182.
Based on available data on eye irritation, the test item requires classification for skin irritation Cat. 2 (H319: Causes serious eye irritation) according to Regulation (EC) No 1272/2008 (CLP), as amended for the fifteenth time in Regulation (EU) 2020/1182.
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.