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EC number: 430-550-0 | CAS number: 1671-49-4
- 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: not irritating, OECD 404 (Draize criteria), Lees 1999
Eye: not irritating, OECD 405 (modified Kay and Calandra system), Lees 1999
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:
- 11 September - 28 September 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant, guideline study, no restrictions, fully adequate for assessment
- 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
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-5 (Acute Dermal Irritation)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: young adults
- Weight at study initiation: 2414-3283 g
- Housing: individually, in cages suitable for rabbits of this strain and weight range expected during the course of the study
- Diet: STANRAB SQC ad libitum
- Water: mains water ad libitum
- Acclimation period: at least 6 days
ENVIRONMENTAL CONDITIONS
- Temperature: 17±2°C
- Humidity: 40-70%
- Air changes: approximately 25 per hr
- Photoperiod: 12 hrs dark / 12 hrs light
IN-LIFE DATES: From: 13 September 1995 To: 28 September 1995 - Type of coverage:
- occlusive
- Preparation of test site:
- other: clipped
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- corn oil
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): approximately 500 mg
- The test substance was moistened to a dry paste with approximately 0.5 mL corn oil
VEHICLE
- Amount(s) applied (volume or weight with unit): the test substance was moistened with approximately 0.5 mL corn oil to a dry paste - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 4 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: approximately 2.5 cm x 2.5 cm of the left flank
- % coverage: not reported
- Type of wrap if used: the treated area was covered with a piece of 8-ply surgical gauze which was secured by two strips of surgical tape. This was covered by a piece of impermeable rubber sheeting wrapped once around the trunk of the animal and secured with adhesive impermeable polyethylene tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the application site was cleansed free of any residual test material using clean swabs of absorbent cotton wool and clean warm water, then dried with clean tissue paper.
- Time after start of exposure: approximately 4 hours
SCORING SYSTEM
- The Draize scale (Draize JH (1959) Third printing, 1975. 'Dermal Toxicity' in 'Appraisal of the safety of chemicals in food, drugs and cosmetics'. Association of Food and Drug Officials of the US, pp46-59) was used to assess the degree of erythema and oedema approximately 30 minutes and 1, 2, 3 and (for one animal) 4 days after removal of the dressings. Any other signs of skin irritation were also noted. - Irritation parameter:
- erythema score
- Basis:
- animal: #1, #2, #3
- Time point:
- other: 30 minutes after decontamination
- Score:
- 1
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks:
- no changes at any timepoint
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Basis:
- animal: #1, #2, #3
- Time point:
- other: 30 minutes after decontamination
- Score:
- 1
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks:
- no changes at any timepoint
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks:
- no changes at any timepoint
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Reversibility:
- fully reversible within: 48 hours
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- This test substance is a slight irritant following a single four-hour application to rabbit skin. The substance does not meet the criteria for classification.
- Executive summary:
A group of 3 female rabbits received a single four-hour application of 500 mg of the test substance to the shorn flank. The animals were assessed for up to 4 days for any signs of skin irritation.
Very slight erythema was seen in all three animals approximately 1 hour after decontamination and in two animals for the following 2 or 3 days. Very slight oedema was seen in all three animals approximately 1 hour after decontamination and in one animal for 1 day. All signs of irritation had completely resolved 4 days after application.
The test substance is a slight irritant following a single four-hour application to rabbit skin.
Reference
Table1: Individual and mean skin irritation scores according to the Draize scheme
Time |
Erythema |
Oedema |
||||
Animal number |
2 |
10 |
11 |
2 |
10 |
11 |
after 1 hour |
1 |
1 |
1 |
1 |
1 |
1 |
after 24 hours |
1 |
0 |
1 |
0 |
0 |
1 |
after 48 hours |
1 |
0 |
1 |
0 |
0 |
0 |
after 72 hours |
1 |
0 |
0 |
0 |
0 |
0 |
mean score 24-72 hours |
1 |
0 |
0.7 |
0 |
0 |
0.3 |
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:
- 11 September - 28 September 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant, guideline study, no restrictions, fully adequate for assessment
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-4 (Acute Eye Irritation)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: young adults
- Weight at study initiation: 2553-3045 g
- Housing: individually, in cages suitable for rabbits of this strain and weight range expected during the course of the study
- Diet: STANRAB SQC ad libitum
- Water: mains water ad libitum
- Acclimation period: at least 6 days
ENVIRONMENTAL CONDITIONS
- Temperature: 17±2°C
- Humidity: 40-81%
- Air changes: approximately 25-30 per hr
- Photoperiod: 12 hrs dark / 12 hrs light
IN-LIFE DATES: From: 13 September 1995 To: 28 September 1995 - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- Approximately 100 mg
- Duration of treatment / exposure:
- Single dose
- Observation period (in vivo):
- 4 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): the eyes were not washed.
SCORING SYSTEM: an assessment of initial pain was made using a six-point scale. The Draize scale (Draize JH (1959) Third printing, 1975. 'Dermal Toxicity' in 'Appraisal of the safety of chemicals in food, drugs and cosmetics'. Association of Food and Drug Officials of the US, pp46-59) was used to assess the grade of ocular reaction approximately one hour and 1, 2, 3 and (for one animal) 4 days after application.
TOOL USED TO ASSESS SCORE: fluorescein staining was used at all readings from day 1 after application.
A modified form of the Kay and Calandra system (Kay JH and Calandra JC 1962, Interpretation of eye irritation tests. J Soc Cosmet Chem 13, pp281-289) was used to interpret and classify the numerical scores. - Irritation parameter:
- other: initial pain
- Basis:
- mean
- Time point:
- other: immediately after application
- Remarks on result:
- other: none or slight initial pain (class 0-2 on a 0-5 scale)
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 1.2 hrs, 1, 2, 3 and (for one animal) 4 days
- Score:
- 0
- Max. score:
- 80
- Remarks on result:
- other: no corneal effects in any animal
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 1.2 hrs, 1, 2, 3 and (for one animal) 4 days
- Score:
- 0
- Max. score:
- 10
- Remarks on result:
- other: no effects in the iris in any animal
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 1.2 hrs
- Score:
- 9.3
- Max. score:
- 20
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: day 1
- Score:
- 2
- Max. score:
- 20
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: day 2
- Score:
- 2
- Max. score:
- 20
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #15
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks:
- no change at any timepoint
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #12
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks:
- no change at any timepoint
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #13
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks:
- No change at any timepoint
- Irritation parameter:
- iris score
- Basis:
- animal: #15
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks:
- no change at any timepoint
- Irritation parameter:
- iris score
- Basis:
- animal: #12
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks:
- No change at any timepoint
- Irritation parameter:
- iris score
- Basis:
- animal: #13
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks:
- No change at any timepoint
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #15
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #12
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #13
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal: #15
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks:
- No change at any timepoint
- Irritation parameter:
- chemosis score
- Basis:
- animal: #12
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks:
- No change at any timepoint
- Irritation parameter:
- chemosis score
- Basis:
- animal: #13
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks:
- No change at any timepoint
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The substance is a mild irritant (class 4 on a 1-8 scale) to the rabbit eye. The substance does not meet the criteria for classification.
- Executive summary:
The test substance (100 mg) was applied into one eye of each of three rabbits and an assessment of initial pain was made. The eyes were examined for up to 4 days, to assess the grade of ocular reaction.
Application into the eye caused no or slight pain (class 0 -2 on a 0 -5 scale). There were no corneal or iridial effects. Conjunctival effects were seen in all animals for up to 2 days. All signs of irritation had completely resolved 3 days after application.
The test substance is a mild irritant (class 4 on a 1-8 scale) to the rabbit eye.
Reference
Approximately 1/3 or 1/2 of the test substance was displaced from the conjunctival sac of two animals immediately after application.
Application into the eye caused no or slight pain (class 0 -2 on a 0 -5 scale). There were no corneal or iridial effects. Conjunctival effects, in all animals for up to 2 days, consisted of slight or moderate redness, slight or mild chemosis and a slight or moderate discharge. In addition, two animals had a slight mucoid discharge. All signs of irritation had completely resolved 3 days after application.
Eye irritation scores of according to the Draize scheme
Time |
Cornea |
Iris |
Conjunctiva |
||||||||||
|
|
|
|
Redness |
Chemosis |
||||||||
Animal number |
15 |
12 |
13 |
15 |
12 |
13 |
15 |
12 |
13 |
15 |
12 |
13 |
|
after 1 hour |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
1 |
2 |
1 |
1 |
2 |
|
after 24 hours |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
1 |
0 |
0 |
0 |
|
after 48 hours |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
1 |
0 |
0 |
0 |
|
after 72 hours |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
mean scores 24-72 hours |
0 |
0 |
0 |
0 |
0 |
0 |
0.7 |
0.7 |
0.7 |
0 |
0 |
0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin Irritation
A group of 3 female rabbits received a single four-hour application of 500 mg of the test substance to the shorn flank. The animals were assessed for up to 4 days for any signs of skin irritation. Very slight erythema was seen in all three animals approximately 1 hour after decontamination and in two animals for the following 2 or 3 days. Very slight oedema was seen in all three animals approximately 1 hour after decontamination and in one animal for 1 day. All signs of irritation had completely resolved 4 days after application. The test substance is a slight irritant following a single four-hour application to rabbit skin.
Eye Irritation
The test substance (100 mg) was applied into one eye of each of three rabbits and an assessment of initial pain was made. The eyes were examined for up to 4 days, to assess the grade of ocular reaction. Application into the eye caused no or slight pain (class 0 -2 on a 0 -5 scale). There were no corneal or iridial effects. Conjunctival effects were seen in all animals for up to 2 days. All signs of irritation had completely resolved 3 days after application.The test substance is a mild irritant (class 4 on a 1-8 scale) to the rabbit eye.
Justification for selection of skin
irritation / corrosion endpoint:
Only one study was available for skin irritation. The available data
are considered to be relevant, reliable and adequate for risk
assessment, classification and labelling of the substance.
Justification for selection of eye irritation endpoint:
Only one study was available for eye irritation. The available data
are considered to be relevant, reliable and adequate for risk
assessment, classification and labelling of the substance.
Justification for classification or non-classification
Skin irritation/corrosion
In an OECD 404 compliant study the substance is slightly irritating when assessed according to the Draize scheme. It does not meet the criteria for classification as irritating to the skin according to Regulation (EC) No. 1272/2008, Annex I, Part 3, 3.2.2
Eye irritation
In an OECD 405 compliant study the substance is a mild irritant when assessed using a modified form of the Kay and Calandra system. It does not meet the criteria for classification as irritant to the eye according to Regulation (EC) No. 1272/2008, Annex I, Part 3, 3.2
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