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EC number: 214-540-1 | CAS number: 1143-72-2
- 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 considered a very mild irritant to skin.
Based on the observations up to day 7 after treatment, the test item is considered to cause irreversible damage to the cornea and thus, cause serious eye damage.
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:
- 1983
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The study was conducted according to the Draize protocol (occlusive dressing, 24 h exposure period, abraded and intact test sites). Restrictions of the study: reading time point after 48 h missing, no individual scores, observation period terminated after 72 h
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elkhorn Rabbitry of Watsonville, CA, USA
- Weight at study initiation: 2 - 3 kg
- Housing: Animals were individually housed in hanging wire cages.
- Diet: Approximately 150 g of a commercial rabbit chow (Purina Rabbit Chow Complete Blend); fresh vegetables on occasion.
- Water: UV-purified drinking water, ad libitum.
- Acclimation period: 4 - 5 days
ENVIRONMENTAL CONDITIONS
- Air changes (per hr): air-conditioned rooms - Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 g
- Duration of treatment / exposure:
- 24 h
- Observation period:
- Reading time points: 24 and 72 h
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: Two unabraded and two abraded test sites were used on the dorsal area of the trunk of each rabbit. The back of each rabbit was clipped free of hair the day before treatment.
- Type of wrap if used: Each application site was covered with a gauze pad and the entire back was wrapped with a rubber dam.
OBSERVATION TIME POINTS: 24 and 72 h
SCORING SYSTEM: Draize scoring system - Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of all 6 animals
- Time point:
- 24 h
- Remarks on result:
- other: no individual Draize scores were given in the study report
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of all 6 animals
- Time point:
- 24 h
- Remarks on result:
- other: no individual Draize scores were given in the study report
- Irritation parameter:
- erythema score
- Time point:
- 48 h
- Remarks on result:
- other: animals were not observed at the 48-h reading time point
- Irritation parameter:
- edema score
- Time point:
- 48 h
- Remarks on result:
- other: animals were not observed at the 48-h reading time point
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- mean of all 6 animals
- Time point:
- 72 h
- Remarks on result:
- other: no individual Draize scores were given in the study report
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- mean of all animals
- Time point:
- 72 h
- Remarks on result:
- other: no individual Draize scores were given in the study report
- Irritant / corrosive response data:
- 24 h after the application of the test substance barely perceptible to slight erythema at the treated sites in 4/6 animals were observed. 72 h after treatment a few scattered sites continued to have barely perceptible erythema. No edema was observed in any animal after 24 h and 72 h of observation. The primary irritation score was calculated to be 0.6.
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Remarks:
- As worst case assessment the test substance is considered as irritant to the skin.
- Conclusions:
- The test item is considered a very mild irritant to skin.
- Executive summary:
A study was conducted to evaluate the potential to cause skin irritation. Six male rabbits were treated with undiluted test item. The back of each rabbit was clipped free of hair the day before treatment. Two unabraded and two abraded test sites were used on the dorsal area of the trunk of each rabbit. Each application site was covered with a gauze pad and the entire back was wrapped with a rubber dam. After 24 h the pads and wraps were removed and sites were scored for erythema and edema after 24 and 72 h according to Draize test grading system. 24 h after the application of the test substance barely perceptible to slight erythema at the treated sites in 4/6 animals were observed. 72 h after treatment a few scattered sites continued to have barely perceptible erythema. No edema was observed in any animal after 24 h and 72 h of observation. The primary irritation score was calculated to be 0.6. The test item is considered a very mild irritant to skin.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (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:
- 1983
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted 02 Oct 2012
- Deviations:
- yes
- Remarks:
- (analgesics and anesthetics were not used before instillation of the test substance, no individual scores were given, observation period terminated after 7 days instead of 21 days, no information on the purity of the test substance, non-GLP)
- GLP compliance:
- no
- Species:
- rabbit
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Elkhorn Rabbitry of Watsonville, CA, USA
- Weight at study initiation: 2 - 3 kg
- Housing: Animals were individually housed in hanging wire cages.
- Diet: Approximately 150 g of a commercial rabbit chow (Purina Rabbit Chow Complete Blend); fresh vegetables on occasion.
- Water: UV-purified drinking water, ad libitum.
- Acclimation period: 4 - 5 days
ENVIRONMENTAL CONDITIONS
- Air changes (per hr): air-conditioned rooms - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 g - Duration of treatment / exposure:
- single application without washing, washing of the eyes after 30 s and 5 min (3 rabbits/group each)
- Observation period (in vivo):
- Reading time points: 24, 48, 72 and 96 h and 7 days
- Number of animals or in vitro replicates:
- 3 animals per exposure group
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: In two groups, the treated eye was washed 30 s and 5 min after instillation, respectively. - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of all 3 animals
- Time point:
- 24/48/72 h
- Remarks on result:
- other: no individual Draize scores were given in the study report
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of all 3 animals
- Time point:
- 24/48/72 h
- Remarks on result:
- other: no individual Draize scores were given in the study report
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- of all 3 animals
- Time point:
- 24/48/72 h
- Remarks on result:
- other: no individual Draize scores were given in the study report
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of all 3 animals
- Time point:
- 24/48/72 h
- Remarks on result:
- other: no individual Draize scores were given in the study report
- Irritant / corrosive response data:
- Corneal and iridic lesions were observed in all exposure groups beginning at 24 or 48 h after treatment. All rabbits exhibited conjunctival reactions of redness, swelling, and/or discharge. The ocular lesions were present during the first 96 h and in some cases persisted throughout the 1-week study period.
In the animals whose eyes were exposed to the test substance as single application without washing the test substance adhered to the inside of the eyelids during the initial reading time point of 24 h in 3/3 rabbits, persisting as dark material inside the eye lid in 2/3 rabbits. Slight pannus formation was also noted by the end of the study indicating possible permanent damage to the corneas in 3/3 animals in this exposure group.
In the animals whose eyes were exposed to the test substance for 30 s a darkened area was noted in 1/3 rabbits on Day 7. Slight conjunctival redness was also observed in 1/3 animals by the end of the 1-week study in this exposure group.
On day 7 2/3 rabbits of the 5 min wash group had clear eyes and 1 rabbit of the 30 s wash group had normals eyes besides slight conjunctival redness. All 3 rabbits of the no wash group had slight pannus formation. - Other effects:
- 1 rabbit of the 30 s wash group died on Day 7. Expect for diarrhea, which was present at the beginning of the study, no gross abnormalities were found. Thus, the death is considered unrelated to treatment.
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Based on the observations up to day 7 after treatment, the test item is considered to cause irreversible damage to the cornea and thus, cause serious eye damage.
- Executive summary:
A study was conducted to evaluate the potential to cause eye irritation. 9 male rabbits were treated with a single application of 0.1 g undiluted test item in one eye each. Animals were divided into groups of 3 for different washing procedures. The eyes of one group were not washed and the eyes of the other groups were washed after 30 s or 5 min. Eyes were graded for ocular lesions after 24, 48, 72 and 96 h and 7 days. The test was terminated after 7 days. The grading system according to Draize was used. Corneal and iridic lesions were observed in all exposure groups beginning at 24 or 48 h after treatment. All rabbits exhibited conjunctival reactions of redness, swelling, and/or discharge. The ocular lesions were present during the first 96 h and in some cases persisted throughout the 1-week study period. In the animals whose eyes were exposed to the test substance as single application without washing the test substance adhered to the inside of the eyelids during the initial reading time point of 24 h in 3/3 rabbits, persisting as dark material inside the eye lid in 2/3 rabbits. Slight pannus formation was also noted by the end of the study indicating possible permanent damage to the corneas in 3/3 animals in this exposure group. In the animals whose eyes were exposed to the test substance for 30 s a darkened area was noted in 1/3 rabbits on Day 7. Slight conjunctival redness was also observed in 1/3 animals by the end of the 1-week study in this exposure group. On day 7 2/3 rabbits of the 5 min wash group had clear eyes and 1 rabbit of the 30 s wash group had normal eyes besides slight conjunctival redness. All 3 rabbits of the no wash group had slight pannus formation. 1 rabbit of the 30 s wash group died on Day 7. Expect for diarrhea, which was present at the beginning of the study, no gross abnormalities were found. Therefore, the death is considered unrelated to treatment. Based on the observations up to day 7 after treatment, the test item is considered to cause irreversible damage to the cornea and thus, cause serious eye damage.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
A study was conducted to evaluate the potential to cause skin irritation. Six male rabbits were treated with undiluted test item. The back of each rabbit was clipped free of hair the day before treatment. Two unabraded and two abraded test sites were used on the dorsal area of the trunk of each rabbit. Each application site was covered with a gauze pad and the entire back was wrapped with a rubber dam. After 24 h the pads and wraps were removed and sites were scored for erythema and edema after 24 and 72 h according to Draize test grading system. 24 h after the application of the test substance barely perceptible to slight erythema at the treated sites in 4/6 animals were observed. 72 h after treatment a few scattered sites continued to have barely perceptible erythema. No edema was observed in any animal after 24 h and 72 h of observation. The primary irritation score was calculated to be 0.6. The test item is considered a very mild irritant to skin.
Eye irritation
Key study
A study was conducted to evaluate the potential to cause eye irritation. 9 male rabbits were treated with a single application of 0.1 g undiluted test item in one eye each. Animals were divided into groups of 3 for different washing procedures. The eyes of one group were not washed and the eyes of the other groups were washed after 30 s or 5 min. Eyes were graded for ocular lesions after 24, 48, 72 and 96 h and 7 days. The test was terminated after 7 days. The grading system according to Draize was used. Corneal and iridic lesions were observed in all exposure groups beginning at 24 or 48 h after treatment. All rabbits exhibited conjunctival reactions of redness, swelling, and/or discharge. The ocular lesions were present during the first 96 h and in some cases persisted throughout the 1-week study period. In the animals whose eyes were exposed to the test substance as single application without washing the test substance adhered to the inside of the eyelids during the initial reading time point of 24 h in 3/3 rabbits, persisting as dark material inside the eye lid in 2/3 rabbits. Slight pannus formation was also noted by the end of the study indicating possible permanent damage to the corneas in 3/3 animals in this exposure group. In the animals whose eyes were exposed to the test substance for 30 s a darkened area was noted in 1/3 rabbits on Day 7. Slight conjunctival redness was also observed in 1/3 animals by the end of the 1-week study in this exposure group. On day 7 2/3 rabbits of the 5 min wash group had clear eyes and 1 rabbit of the 30 s wash group had normal eyes besides slight conjunctival redness. All 3 rabbits of the no wash group had slight pannus formation. 1 rabbit of the 30 s wash group died on Day 7. Expect for diarrhea, which was present at the beginning of the study, no gross abnormalities were found. Therefore, the death is considered unrelated to treatment. Based on the observations up to day 7 after treatment, the test item is considered to cause irreversible damage to the cornea and thus, cause serious eye damage.
Supporting study
An in vivo eye irritation study in rabbits was conducted according to OECD 405. Three rabbits without ocular abnormalities were used. The test substance (100 mg) was administered to one eye while the other eye served as control. Washing was done 24 h after treatment. The eyes were examined 1, 24, 42 and 72 h after administration. At 24 and 72 h as well as after 7 days, the eyes were also examined for corneal lesions under UV light after instillation of one drop of a 0.01 % fluorescein sodium solution. Lesions in cornea, iris or conjunctivae were graded and all other changes or toxic effects were recorded. One hour after administration the conjunctivae showed definitely injected blood vessels up to a diffuse beefy red color and very light swellings up to swellings with lids about half closed. The iris was sporadically reddend. The cornea showed diffuse up to translucent opacity areas. Additionally, clear-colorless or substance colored eye discharge occurred sporadically during the observation period. Seven days after administration all signs of irritation were reversible. The primary eye irritation test in the rabbit showed that the test item was irritating to the 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 skin and eye irritation, the test item requires classification for causing skin irritation Category 2 (H315: Causes skin irritation) and for causing serious damage to the eye Category 1 (H318: Causes serious eye damage) according to Regulation (EC) No 1272/2008 (CLP).
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