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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 600-254-8 | CAS number: 10195-54-7
- 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 is not skin irritating, but severely eye damaging.
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:
- 1998
- 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:
- 1993
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 1992
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage Scientifique des Dombes, F-01400 Chatillon sur Chalaronne
- Age at study initiation: 15 weeks
- Weight at study initiation: 3057 - 3151 g
- Housing: Standard Laboratory Conditions (Individually in stainless steel cages with an automatic cleaning system equipped with feed hoppers, drinking water bowls, with haysticks and wood for gnawing)
- Diet: Pelleted standard Kliba 3410 ("Kliba", Kliba Miihlen AG, 4303 Kaiseraugst, Switzerland) rabbit maintenance diet ad libitum (batch no. 61/98).
- Water: Community tap water from Itingen, ad libitum, in water bowls. Results of analysis are archived by RCC.
- Acclimation period: Four days under laboratory conditions after health examination. Only animals without any visual signs of illness were used for the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ±3°C
- Humidity (%): relative humidity 40-70% (values above 70% during cleaning process possible)
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle. Recorded music was played for approximately 8 hours during the light period
IN-LIFE DATES:
Delivery of the animals: 09 June 1998
Acclimatization: 10-14 June 1998
Treatment: 15 June 1998
Observation: 15-30 June 1998
Euthanasia of the animals: 30 June 1998 - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- yes, concurrent no treatment
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5g per animal
VEHICLE
the solid test item was moistened with bidistilled water - Duration of treatment / exposure:
- 4h
- Observation period:
- 14 days
- Number of animals:
- 3 animals: 2 females, 1 male
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm²
- Type of wrap: surgical gauze and a semi-occlusive dressing
REMOVAL OF TEST SUBSTANCE
- Washing: flushed with lukewarm tap water
- Time after start of exposure: 4h
OBSERVATION TIME POINTS
mortality and clinical signs daily, body weight at start of acclimatization, on the first day of application and at termination of observation
SCORING SYSTEM:
- Method of calculation:
The skin reaction was assessed according to the numerical scoring system listed in the EEC Commission Directive 92/69/EEC, July 31, 1992 at approximately 1, 24, 48 and 72 hours as well as 7 and 14 days after the removal of the dressing, gauze patch and test article. If evident, corrosive or staining properties of the test article were described and recorded. - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Application of the test article to healthy intact rabbit skin resulted in a primary irritation score of 1.33. Local signs (mean values from 24 to 72 hours) consisted of grade 1.33 erythema and grade 0.00 edema. Very slight to well-defined erythema was noted in all animals. This finding was reversible in two animals after 7 days, but persisted in the third animal after 14 days.
No irreversible alterations of the treated skin were observed nor were corrosive effects evident on the skin. - Other effects:
- No clinical signs of systemic toxicity were observed in the animals during the test and observation period, and no mortality occurred. No staining by the test article of the treated skin was observed.
The body weight of all rabbits were considered to be within the normal range of variability. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- On the basis of the results obtained in this study according to OECD 404, the test substance does not possess any primary irritating properties to the skin of albino rabbits under the test conditions chosen.
- Executive summary:
In this study, the potential irritant and/or corrosive effects of the test substance were evaluated on the skin of New Zealand White rabbits according ot OECD 404. Each of three rabbits received a 0.5g dose of the test article to 6 cm² intact dorsal skin. The duration of treatment was four hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours as well as 7 and 14 days after removal of the dressing. The scores of each animal at the following reading times (24, 48, 72 hours) were used in calculating the respective mean values for each type of lesion. The irritation score was calculated per animal at 24, 48 and 72 hours, summed up and then dividing by the number of data points. The irritation score for erythema was 1.33 for all three animals (max. 8.0). This finding was reversible in two animals after 14 days, but persisted in the third animal after 14 days. Local signs (mean values from 24 to 72 hours) consisted also of grade 0.00 edema. The test article did not cause staining of the treated skin. No corrosive effects were noted on the treated skin of any animal at any measuring interval. The test article is not considered to be "irritating" to rabbit skin.
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:
- 1998
- 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:
- 1987
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- 1992
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source:Elevage Scientifique des Dombes, F-01400 Chatillon sur Chalaronne
- Age at study initiation: 15 weeks
- Weight at study initiation: 2738 - 3158 g
- Housing: Standard Laboratory Conditions (Individually in stainless steel cages with an automatic cleaning system equipped with feed hoppers, drinking water bowls, wood and haysticks for gnawing)
- Diet: Pelleted standard Kliba 3410 ("Kliba", Kliba Muhlen AG, .4303 Kaiseraugst, Switzerland) rabbit maintenance diet ad libitum (batch no. 61/98).
- Water: Community tap water from Itingen, ad libitum, in water bowls.
- Acclimation period: Five days under laboratory conditions after health examination. Only animals without any visual signs of illness were used for the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ±3°C
- Humidity (%): 40-70% (values above 70% during cleaning process possible)
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): The room was illuminated by fluorescent light on a 12 hour light/dark cycle. Recorded music was played for approximately 8 hours during the light period.
IN-LIFE DATES:
Delivery of the animals: 16 June 1998
Acclimatization: 17-21 June 1998
Treatment: 22 June 1998
Observation: 22 June-13 July 1998
Euthanasia of the animals: 13 July 1998 - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1g per animal undiluted - Duration of treatment / exposure:
- The treated eyes were not rinsed after application.
- Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- 3 animals: 2 females, 1 male
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: no
SCORING SYSTEM :The ocular reaction was assessed according to the numerical scoring system listed in the EEC Commission Directive 92/69/EEC, July 31, 1992
TOOL USED TO ASSESS SCORE: Eye examinations were made with a Varta Cliptrix diagnostic-lamp (A. Riegger, Basel / Switzerland). - Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Remarks:
- after 7 days: score 3
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.6
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.66
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.66
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritant / corrosive response data:
- Application of the test article to healthy rabbit conjunctivae resulted in a primary irritation score of 4.33.
No corrosion of the comea was observed at any of the reading times. No staining of the cornea, sclera or conjunctivae by the test article was observed. - Other effects:
- The body weight of all rabbits were considered to be within the normal range of variability.
No clinical signs of systemic toxicity were observed in the animals during the test and observation period, and no mortality occurred. - Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Under the conditions of the test according to OECD 405, the test substance is considered to be severely damaging the rabbit eye.
- Executive summary:
In this study, the potential irritant and/or corrosive effects of the test substance were evaluated on the eyes of New Zealand White rabbits according ot OECD 405. Each of three rabbits received a 0.1g dose of the test article in the conjunctival sac of the left eye. The treated eyes were not rinsed after application. The contralateral eye of each animal remained untreated and served as a control. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours as well as 7, 14 and 21 days after test article application. The scores of each animal at the following reading times (24, 48 and 72 hours) were used in calculating the respective mean values for each type of lesion. No staining of the comea or sclera of the treated eyes by the test article was observed. The mean score (24/48/72h) for cornea opacity was between 0 and 1, not fully reversible in one animal; for conjunctivae the mean score was between 1.66 and 2, fully reversible within 14 days;chemosis score between 0.66 and 2.66, fully reversible within a maximum of 14 days. No corrosion was observed at any of the measuring intervals. Based upon the degree of chemosis and the persistent corneal opacity noted in one animal after 21 days the test item is considered to be severely eye damaging to the rabbit eye.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
OECD 404
In this study, the potential irritant and/or corrosive effects of the test substance were evaluated on the skin of New Zealand White rabbits according ot OECD 404. Each of three rabbits received a 0.5g dose of the test article to 6 cm² intact dorsal skin. The duration of treatment was four hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours as well as 7 and 14 days after removal of the dressing. The scores of each animal at the following reading times (24, 48, 72 hours) were used in calculating the respective mean values for each type of lesion. The irritation score was calculated per animal at 24, 48 and 72 hours, summed up and then dividing by the number of data points. The irritation score for erythema was 1.33 for all three animals (max. 8.0). This finding was reversible in two animals after 14 days, but persisted in the third animal after 14 days. Local signs (mean values from 24 to 72 hours) consisted also of grade 0.00 edema. The test article did not cause staining of the treated skin. No corrosive effects were noted on the treated skin of any animal at any measuring interval. The test article is not considered to be "irritating" to rabbit skin.
OECD 405
In this study, the potential irritant and/or corrosive effects of the test substance were evaluated on the eyes of New Zealand White rabbits according ot OECD 405. Each of three rabbits received a 0.1g dose of the test article in the conjunctival sac of the left eye. The treated eyes were not rinsed after application. The contralateral eye of each animal remained untreated and served as a control. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours as well as 7, 14 and 21 days after test article application. The scores of each animal at the following reading times (24, 48 and 72 hours) were used in calculating the respective mean values for each type of lesion. No staining of the comea or sclera of the treated eyes by the test article was observed. The mean score (24/48/72h) for cornea opacity was between 0 and 1, not fully reversible in one animal; for conjunctivae the mean score was between 1.66 and 2, fully reversible within 14 days;chemosis score between 0.66 and 2.66, fully reversible within a maximum of 14 days. No corrosion was observed at any of the measuring intervals. Based upon the degree of chemosis and the persistent corneal opacity noted in one animal after 21 days the test item is considered to be severely eye damaging to the rabbit eye.
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 eye irritation, the
test item is classified and labelled as severely eye damaging Cat 1
(H318: Causes serious eye damage) according
to Regulation (EC) No 1272/2008 (CLP), as amended for the tenth time in
Regulation (EU) No 2017/776.
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 is not classified and labelled as skin irritating according to Regulation (EC) No 1272/2008 (CLP), as amended for the tenth time in Regulation (EU) No 2017/776.
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.