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EC number: 607-858-0 | CAS number: 260781-16-6
- 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: not irritating (OECD 404; GLP)
Eye irritation: irritating (OECD 405; GLP)
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:
- 1993-10-11 to 1993-10-15
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Deviations from the OECD 404 (2015): 4 animals were tested instead of 3. Systemic effects were not investigated. 5 test item concentrations were tested (undiluted, 1, 5, 10, and 25 %). 30 min. observation was conducted instead of a 1 h observation. In one animal the skin effects were not reversible by 72 h, but still the study was terminated.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1992-07-17
- Deviations:
- yes
- Remarks:
- 4 animals were tested instead of 3. Toxic effects not investigated. 5 test item concentrations were tested. 30 min. observation was conducted instead of a 1 h observation. skin effects in 1 animal not reversible by 72 h, but the study was terminated.
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- signed 1993-09-23
- Species:
- rabbit
- Strain:
- other: Mol:Russian
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS - SPF albino rabbits
- Weight at study initiation: 2.3 - 2.9 kg
- Housing: kept in single PPL cages, 45 x 55 cm, with perforated floor
- Diet (ad libitum): feed pellets "Altromin 2123"
- Water (ad libitum): drinking water acidified with hydrochloric acid to pH 2.5
- Acclimation period: at least one week
ENVIRONMENTAL CONDITIONS
- Temperature: 21 ± 3°C
- Relative humidity: 55 ± 15%
- Air changes: 10 times/hour
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL of the undiluted test substance
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 0.5 mL of diethyl phthalate - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 4 female rabbits
- Details on study design:
- TEST SITE
- Area of exposure: area of 10 x 10 cm on the back
- Type of wrap if used: to a patch (2.5 x 2.5 cm) the test substance or vehicle was applied and the patch were placed on the back. The gauze patch was secured with adhesive type and fixed with Scanpor tape loosely wound round the trunk.
REMOVAL OF TEST SUBSTANCE
- Washing: treated skin was cleaned with soap and lukewarm water
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS
30 minutes as well as 24, 48, and 72 hours after application
SCORING SYSTEM: according to the Draize scale
- Method of calculation: scores for erythema and oedema formation for the last 3 readings of each rabbit (24, 48 and 72 hours) for each test concentration were obtained separately and divided by 3. The results are the mean scores for erythema and oedema formation of the individual rabbit. - Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: reading of 100% test concentration
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: reading of 100% test concentration
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: reading of 100% test concentration
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: reading of 100% test concentration
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- other: not specified, if skin reaction was reversible, since the observation period lasted only 72 hours and was not extended unitl reversal occurred or 14 days had elapsed.
- Remarks on result:
- other: reading of 100% test concentration
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: reading of 100% test concentration
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- other: observation was only made at the 48 hour observation
- Remarks on result:
- other: reading of 100% test concentration
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: reading of 100% test concentration
- Irritant / corrosive response data:
- At the one hour reading very slight erythema (grade 1) was observed in three rabbits. One of these rabbits still showed a very slight erythema (grade 1) at the 24 and 48 hour observations and another rabbit of these three rabbits showed the same reaction at the 24, 48, and 72 hours observations.
Lastly, one rabbit only showed very slight erythema (grade 1) at the 48 hour observation.
Apart from that no signs of skin reaction were recorded. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance is not irritating to the skin based on an in vivo study (OECD 404).
According to Regulation (EC) No 1272/2008 and subsequent adaptations, the substance does not require classification as skin irritant. - Executive summary:
The skin irritation potential of the substance was investigated according to the OECD guideline 404 (1992). A single dose of 0.5 mL of the undiluted substance was applied to the skin of four female Mol: Russian rabbits and covered semi-occlusive for an exposure period of 4 hours. The test sites were examined for skin reactions after test item treatment and scored according to the Draize scale after 30 minutes as well as 24, 48 and 72 hours after application.
The following results were recorded:
Animal #1
Erythema: 0
Oedema: 0
Animal #2
Erythema: 0.67
Oedema: 0
Animal #3
Erythema: 1
Oedema: 0
Animal #4
Erythema: 0.33
Oedema: 0
At the one hour reading very slight erythema (grade 1) was observed in three rabbits. One of these rabbits still showed a very slight erythema (grade 1) at the 24 and 48 hour observations and another rabbit of these three rabbits showed the same reaction at the 24, 48, and 72 hours observations. Lastly, one rabbit only showed very slight erythema (grade 1) at the 48 hour observation. Apart from that no signs of skin reaction were recorded.
According to Regulation (EC) No 1272/2008 and subsequent adaptations, the substance does not require classification as skin irritant.
Reference
TEST CONCENTRATIONS:100%, 25 %, 10 %, 5 %, and 1 % (w/w) plus vehicle
No signs of skin irritation were recorded.
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:
- 1993-10-25 to 1993-11-02
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Deviations from the OECD 405 (2012): topical anaesthetics and systemic analgesics were not used. Non-ocular effects and systemic effects were not examined.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1987-02-24
- Deviations:
- yes
- Remarks:
- non-ocular effects were not recorded.
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- signed 1993-09-23
- Species:
- rabbit
- Strain:
- other: Mol:Russian
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS - SPF albino rabbits
- Weight at study initiation: 2.2 - 2.6 kg
- Housing: kept in single PPL cages, 45 x 55 cm, with perforated floor
- Diet (ad libitum): food pellets "Altromin 2123"
- Water (ad libitum): drinking water acidified with hydrochloric acid to pH 2.5
- Acclimation period: at least one week
ENVIRONMENTAL CONDITIONS
- Temperature: 21 ± 3°C
- Relative humidity: 55 ± 15%
- Air changes: 10 times/hour
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL of the undiluted (100%) test item - Duration of treatment / exposure:
- not applicable
- Observation period (in vivo):
- 1, 24, 48, and 72 hours as well as 7 days after the treatment
- Number of animals or in vitro replicates:
- 4 female rabbits
- Details on study design:
- SCORING SYSTEM: Draize scale
TOOL USED TO ASSESS SCORE:
Twenty-four hours after the treatment with the test item an examination was performed before and after instillation of oculoguttae fluoresceini. After instillation of oculoguttae fluoresceini the eyes were rinsed with 0.9% sodium chloride and examined using UV-light to detect possible corneal damage. - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- At the examination 1 hour after dosing cornea was slightly affected in one rabbit. Furthermore, at the 1 hour observation moderate conjunctival redness and slight chemosis were obesrved in three rabbits and slight conjunctival redness and moderate chemosis were observed in one rabbit.
24 hours after dosing cornea was slightly affected in all four rabbits. Moderate to severe chemosis as well as moderate to severe conjunctival redness were observed in all rabbits at the 24 hours observation. At the 48 hour observation slight to moderate chemosis as well as severe conjunctival redenss were observed in all rabbits. At the 72 hour observation slight chemosis was observed in three rabbits and severe conjunctival redness in all rabbits.
The area of opacitiy ranged from more than one quarter up to the whole area at the 24 hour observation and less in severity at the following observations. Discharge fully disappeared by day 7.
Iris was only slightly affected in one rabbit. Moderate discharge was observed at the 1 hour observation and moderate to severe discharge was observed at the 24 hour observation. Slight discharge was only observed in one rabbit at the 48 and 72 hour observations.
After 7 day all ocular effects had recovered. - Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- The substance is irritating to the eyes.
According to the EC Regulation No. 1272/2008 and subsequent adaptations, the substance is classified as an eye irritant (Category 2; H319). - Executive summary:
The eye irritation potential of substance was investigated according to the OECD guideline 405 (1987). A single dose (0.1 mL) of the neat substance was placed into the conjunctival sac of one eye of four Mol:Russian rabbits. The other eye remained untreated and served as control. Ocular reactions were assessed according to the Draize scale 1, 24, 48, and 72 hours as well as 7 days after treatment with the substance. Twenty-four hours after the treatment with the test item an examination was performed before and after instillation of oculoguttae fluoresceini.
The following results were recorded for the three rabbits:
Animal #1
Cornea score: 1.0
Iris score: 0
Conjunctivae score: 2.67
Chemosis score: 1.67
Animal #2
Cornea score: 1
Iris score: 0
Conjunctivae score: 3
Chemosis score: 1.33
Animal #3
Cornea score: 1
Iris score: 0
Conjunctivae score: 3
Chemosis score: 1.67
Animal #4
Cornea score: 1
Iris score: 0.33
Conjunctivae score: 3
Chemosis score: 2.33
At the examination 1 hour after dosing cornea was slightly affected in one rabbit. Furthermore, at the 1 hour observation moderate conjunctival redness and slight chemosis were obesrved in three rabbits and slight conjunctival redness and moderate chemosis were observed in one rabbit. 24 hours after dosing cornea was slightly affected in all four rabbits. Moderate to severe chemosis as well as moderate to severe conjunctival redness were observed in all rabbits at the 24 hours observation. At the 48 hour observation slight to moderate chemosis as well as severe conjunctival redenss were observed in all rabbits. At the 72 hour observation slight chemosis was observed in three rabbits and severe conjunctival redness in all rabbits. The area of opacitiy ranged from more than one quarter up to the whole area at the 24 hour observation and lessened in severity at the following observations. Discharge fully disappeared by day 7. Iris was only slightly affected in one rabbit. Moderate discharge was observed at the 1 hour observation and moderate to severe discharge was observed at the 24 hour observation. Slight discharge was only observed in one rabbit at the 48 and 72 hour observations. After 7 day all ocular effects were recovered.
According to the EC Regulation No. 1272/2008 and subsequent regulations, the test substance is classified as an eye irritant (Category 2; H319).
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Skin irritation
The substance does not possess a skin irritation potential based on an in vivo OECD 404 test and does not require classification as skin irritant according to Regulation (EC) No 1272/2008 and its subsequent adaptations.
Eye irritation
The substance does possess an eye irritation potential based on an in vivo OECD 405 test and does require classification as eye irritant according to Regulation (EC) No 1272/2008 and its subsequent adaptations (Category 2; H319).
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