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EC number: 433-100-1 | CAS number: -
- 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 substance (EC: 433-100-1) was tested for skin and eye irritation/corrosion in rabbits. It showed neither skin irritation/corrosion nor eye irritation/corrosion properties in these tests.
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:
- 1999-01-18 to 1999-01-28
- 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 17 July, 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- Directive 92/69
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Version / remarks:
- June 1996
- Deviations:
- no
- 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: Charles River Deutschland GmbH, D-88353 Kißlegg
- Weight at study initiation: 2.0 to 2.1 kg
- Housing: Individually housed in ABS - plastic rabbit cages
- Diet: ad libitum, Altromin 2123 maintenance diet for rabbits, rich in crude fibre, totally pathogene free-TPF
- Water: ad libitum, tap drinking water
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature: 18 ±3 °C
- Humidity: 55 ± 10%
- Air changes: at least 10 x / hour
- Photoperiod: Artificial light, lighting regime 12 : 12 hours, light 6.30 - 18.30 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: Carboxymethylcellulose
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 g - Duration of treatment / exposure:
- 4 h
- Observation period:
- 1, 24, 48, 72 h
- Number of animals:
- 3 female animals
- Details on study design:
- TEST SITE
- Area of exposure: (approx. 6 cm2) of skin
- Type of wrap if used: gauze patch, which was held in place with non-irritating tape
REMOVAL OF TEST SUBSTANCE
- Washing: yes
- Time after start of exposure: 4 hours
SCORING SYSTEM: Scoring system according to Draize - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- No skin reactions (erythema, oedema) were recorded throughout the observation period of 72 hours as compared to untreated control sites.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item showed no irritant effects on the intact skin after a contact time of 4 hours.
- Executive summary:
The test material was assessed for skin irritation properties according to EU Method B.4/OECD Guideline 404. The test material was applied to the intact skin of New Zealand White rabbits in a single, 4 -hour, semi-occluded application of the test material to the intact skin of three female animals. The test material produced edema scores of 0.0 after 24, 48 and 72 h and erythema scores of 0.0 after 24, 48 and 72 h in all animals and was classified as non-irritatant to the rabbit skin. No corrosive effects were noted.
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:
- 1999-02-01 to 1999-02-05
- 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 24 Feb., 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- Directive 92/69
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Version / remarks:
- June 1996
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH, D-88353 Kißlegg
- Weight at study initiation: 2.2 to 2.5 kg
- Housing: Individually housed in ABS - plastic rabbit cages
- Diet: ad libitum, Altromin 2123 maintenance diet for rabbits, rich in crude fibre, totally pathogene free-TPF
- Water: ad libitum, tap drinking water
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature: 18 ±3 °C
- Humidity: 55 ± 10%
- Air changes: at least 10 x / hour
- Photoperiod: Artificial light, lighting regime 12 : 12 hours, light 6.30 - 18.30 - Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 g of solid was applied to the test site - Duration of treatment / exposure:
- 72 h
- Observation period (in vivo):
- 1, 24, 48, 72 h
- Number of animals or in vitro replicates:
- 3 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: no
TOOL USED TO ASSESS SCORE: fluorescein solution - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.22
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritant / corrosive response data:
- 1 hour after application a slight erythema and chemosis of the conjunctivae was visible in all animals. Slight signs of irritation were visible at the 24 h reading in all of the 3 test animals. In one animal slight erythema was also visible at the 48 hour reading. No changes were visible at the 72 h reading in any of the 3 test animals. No corneal lesions were found upon fluorescein examination at the 72 h reading. The test item produced no corrosion or irreversible effects in any of the animals.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- It can be concluded that test substance (EC: 433-100-1) does not cause eye irritation in rabbits.
- Executive summary:
A study was performed to assess the Irritancy potential of the test substance (EC: 433-100-1) to the eye of the New Zealand White rabbit. The method used followed the OECD Guidelines for Testing of Chemicals No. 405 "Acute Eye Irritation/Corrosion" (adopted 24 February 1987) and Method B.5 of Commission Directive 92/69/EEC. A single application of the test material at a dose of 0.1 g to the non-irrigated eye of three female rabbits was done. One hour after application a slight erythema and chemosis of the conjunctivae was visible in all animals. Slight signs of irritation were visible at the 24 h reading in all of the 3 test animals. In one animal slight erythema was also visible at the 48 hour reading. No changes were visible at the 72 h reading in any of the 3 test animals. No corneal lesions were found upon fluorescein examination at the 72 h reading. The test item produced no corrosion or irreversible effects in any of the animals. Thus, it can be concluded that the test substance (EC: 433-100-1) does not cause eye irritation in rabbits.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin Irritation:
The test material was assessed for skin irritation properties according to EU Method B.4/OECD Guideline 404. The test material was applied to the intact skin of New Zealand White rabbits in a single, 4-hour, semi-occluded application of the test material to the intact skin of three female animals. The test material produced edema scores of 0.0 after 24, 48 and 72 h and erythema scores of 0.0 after 24, 48 and 72 h in all animals and was classified as non-irritant to the rabbit skin. No corrosive effects were noted.
Eye irritation:
A study was performed to assess the Irritancy potential of the test substance (EC: 433-100-1) to the eye of the New Zealand White rabbit. The method used followed the OECD Guidelines for Testing of Chemicals No. 405 "Acute Eye Irritation/Corrosion" (adopted 24 February 1987) and Method B.5 of Commission Directive 92/69/EEC. A single application of the test material at a dose of 0.1 g to the non-irrigated eye of three female rabbits was done. One hour after application a slight erythema and chemosis of the conjunctivae was visible in all animals. Slight signs of irritation were visible at the 24 h reading in all of the 3 test animals. In one animal slight erythema was also visible at the 48 hour reading. No changes were visible at the 72 h reading in any of the 3 test animals. No corneal lesions were found upon fluorescein examination at the 72 h reading. The test item produced no corrosion or irreversible effects in any of the animals. Thus, it can be concluded that the test substance (EC: 433-100-1) does not cause eye irritation in rabbits.
Justification for classification or non-classification
Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data is reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data on skin and eye irritation/corrosion, the test item is not classified according to Regulation (EC) No 1272/2008 (CLP), as amended for the twelfth time in Regulation (EU) No 2019/521.
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