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EC number: 280-084-5 | CAS number: 82985-35-1
- 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 (OCED TG 404): not irritating
Eye irritation (OECD TG 405): causes irreversible effects to the eye
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- The study was well documented and meets generally accepted scientific principles, but was not conducted in compliance with GLP. No information is given on the test material purity.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- use of 6 animals; observation period 7 d; rather occlusive conditions
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2-3 kg
- Fasting period before study: none
- Diet: appropriate commercial diet, ad libitum
- Water: municipal water, ad libitum - Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 ml - Duration of treatment / exposure:
- 4 h
- Observation period:
- 7 d
- Number of animals:
- 3 male and 3 female rabbbits
- Details on study design:
- TEST SITE
- Type of wrap if used: gauze patch loosely covered with impervious sheeting
REMOVAL OF TEST SUBSTANCE
- Washing: removal of test substance
- Time after start of exposure: 4 h
SCORING SYSTEM: Draize scoring system - Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 1.4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7d
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 1.4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 d
- Irritant / corrosive response data:
- In addition to the oedema and erythema scores (see table 1) desquamation and fissuring was observed. Desquamation was observed in all animals from day 1 to day 7. Fissuring was observed after 5 h in all animals and was only present in the females after 24 h. In 1 animal fissuring was still observed after 7 d. The chemical residue was apparent on the skin in all animals at all time points.
- Interpretation of results:
- other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008
- Conclusions:
- The test item was investigated for skin irritation/corrosion broadly according to the OECD TG 404, but not in compliance with GLP. 0.5 ml of the undiluted test material was occlusively applied to the clipped skin of 3 male and 3 female New Zeeland White rabbits. After 4 h of exposure the test material was removed and the animals were maintained for a 7 day-observation period. The mean erythema and oedema scores were 1.4 each and were not fully reversible until study termination. In addition, desquamation and fissuring was observed. Desquamation was observed in all animals from day 1 to day 7, whereas fissuring was observed after 5 h in all animals and was only present in the females after 24 h. In one animal fissuring was still observed after 7 d. The chemical residue was apparent on the skin in all animals at all time points. The authors concluded the test item to be slightly irritating. Nevertheless, since mean animal scores do not exceed 1.4, the individual scores at 24, 48, and 72 h reading time points never exceeded a score of 2, and individual animal scores throughout the only 7 days lasting observation period give evidence that the effects are transient, classification for skin irritation according to 67/584/EEC and EC/1272/2008 is not warranted.
Reference
Table 1: Individual results of the skin irritation study.
Observation time | Rabbit no. | |||||||||||
1 | 2 | 3 | 4 | 5 | 6 | |||||||
Erythema | Edema | Erythema | Edema | Erythema | Edema | Erythema | Edema | Erythema | Edema | Erythema | Edema | |
5 h | 2 | 1 | 4 | 1 | 4 | 1 | 2 | 1 | 2 | 1 | 1 | 1 |
24 h | 1 | 1 | 2 | 2 | 1 | 1 | 1 | 1 | 1 | 2 | 1 | 2 |
48 h | 2 | 1 | 2 | 2 | 2 | 2 | 1 | 0 | 1 | 2 | 1 | 2 |
72 h | 2 | 1 | 2 | 2 | 2 | 2 | 1 | 0 | 1 | 1 | 1 | 1 |
7 d | 2 | 1 | 2 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 1 | 0 |
Mean value 24 + 48 + 72 h | 1.66 | 1 | 2 | 2 | 1.66 | 1.66 | 1 | 0.33 | 1 | 1.66 | 1 | 1.66 |
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- The study was well documented and meets generally accepted scientific principles, but was not conducted in compliance with GLP. No information is given on the test material purity.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- use of 6 animals; dosage with 0.005 ml test substance
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2-3 kg
- Fasting period before study: none
- Diet: appropriate commercial diet, ad libitum
- Water: municipal water, ad libitum - Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.005 ml - Duration of treatment / exposure:
- single treatment without washing
- Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- 3 males and 3 females
- Details on study design:
- SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: fluorescein (2%) - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 1.22
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 d
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 21 d
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 2.61
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 3.67
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 d
- Irritant / corrosive response data:
- At 24, 48, and 72 h several eyes were encrusted with dry pus. Some necrosis of the conjunctivae was observed at 1 (3/6 animals) and 4 h (5/6 animals).
- Interpretation of results:
- other: Category 1 (irreversible effects on the eye) based on CLP criteria (EU criteria according to Regulation (EC) No. 1272/2008)
- Conclusions:
- A generally reliable study, conducted similar to OECD 405 (not in compliance with GLP), reported that the neat test material caused significant irreversible effects and necrosis to the conjunctiva, iris and cornea of rabbits.
Reference
Table 1: Results of the eye irritation study.
Rabbit # |
Time |
conjunctivae |
iris |
cornea |
|
redness |
swelling |
||||
1 |
1 h |
3 |
3 |
1 |
0 |
24 h |
3 |
4 |
1 |
1 |
|
48 h |
1 |
4 |
1 |
1 |
|
72 h |
2 |
2 |
1 |
1 |
|
7 d |
2 |
1 |
1 |
1 |
|
|
14 d |
0 |
0 |
0 |
0 |
|
21 d |
0 |
0 |
0 |
0 |
2 |
1 h |
3 |
4 |
1 |
0 |
|
24 h |
2 |
4 |
1 |
1 |
|
48 h |
2 |
3 |
1 |
1 |
|
72 h |
3 |
3 |
1 |
1 |
|
7 d |
2 |
1 |
0 |
0 |
|
14 d |
0 |
0 |
0 |
0 |
|
21 d |
0 |
0 |
0 |
0 |
3 |
1 h |
3 |
3 |
1 |
0 |
|
24 h |
3 |
4 |
1 |
1 |
|
48 h |
2 |
3 |
1 |
1 |
|
72 h |
3 |
4 |
1 |
2 |
|
7 d |
2 |
2 |
1 |
2 |
|
14 d |
0 |
0 |
0 |
0 |
|
21 d |
0 |
0 |
0 |
0 |
4 |
1 h |
3 |
2 |
0 |
0 |
|
24 h |
3 |
4 |
1 |
1 |
|
48 h |
3 |
4 |
1 |
1 |
|
72 h |
3 |
4 |
1 |
2 |
|
7 d |
3 |
3 |
1 |
2 |
|
14 d |
0 |
0 |
0 |
0 |
|
21 d |
0 |
0 |
0 |
0 |
5 |
1 h |
3 |
2 |
1 |
0 |
|
24 h |
3 |
4 |
1 |
1 |
|
48 h |
3 |
4 |
1 |
1 |
|
72 h |
2 |
4 |
1 |
1 |
|
7 d |
1 |
3 |
1 |
2 |
|
14 d |
3 |
2 |
1 |
1 |
|
21 d |
1 |
2 |
1 |
2 |
6 |
1 h |
2 |
3 |
1 |
0 |
|
24 h |
3 |
4 |
1 |
1 |
|
48 h |
3 |
3 |
1 |
1 |
|
72 h |
3 |
4 |
- (opacity too great) |
3 |
|
7 d |
3 |
4 |
- (opacity too great) |
3 |
|
14 d |
3 |
3 |
2 |
3 |
|
21 d |
1 |
0 |
1 |
3 |
|
|
|
|
|
|
average |
1 h |
2.83 |
2.83 |
0.83 |
0.0 |
|
24 h |
2.83 |
4.0 |
1.0 |
1.0 |
|
48 h |
2.33 |
3.5 |
1.0 |
1.0 |
72 h |
2.66 |
3.5 |
1.0 (out of 5 animals) |
1.66 |
|
24+48+72 |
2.61 |
3.67 |
1.0 |
1.22 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation/corrosion:
In the available key study (Bushy Run Research Center, 1982a) the test item was investigated for skin irritation/corrosion according to a test protocol that is broadly in accordance with OECD TG 404, but not in compliance with GLP. 0.5 ml of the undiluted test material was occlusively applied to the clipped skin of 3 male and 3 female New Zealand White rabbits. After 4 h of exposure the test material was removed and the animals were maintained for a 7 day-observation period. The mean erythema and oedema scores were 1.4 each and the effects were not fully reversible until study termination. In addition, desquamation and fissuring was observed. Desquamation was observed in all animals from day 1 to day 7, whereas fissuring was observed after 5 h in all animals and was only present in the females after 24 h. In one animal fissuring was still observed after 7 days. The chemical residue was apparent on the skin in all animals at all time points. Nevertheless, since mean animal scores do not exceed 1.4, the individual scores at 24, 48, and 72 h reading time points never exceeded a score of 2, and individual animal scores throughout the only 7 days lasting observation period give evidence that the effects are transient, classification for skin irritation according to 67/584/EEC and EC/1272/2008 is not warranted.
Eye irritation/corrosion:
In the available key study (Bushy Run Research Center, 1982a) the test item was investigated for eye irritation related to corrosivity (see section 5.4.1) similar to the OECD TG 405, but not in compliance with GLP. 3 male and 3 female New Zealand White rabbits received 0.005 ml of the undiluted test material as a single treatment without consecutive washing. The neat test material caused significant irritation to the conjunctiva, iris and cornea of rabbits. Mean scores of all six animals over 24, 48, and 72 h were 1.22 for corneal damage, 1.0 for iritis, 2.61 for conjunctivae scores, and 3.67 for chemosis, respectively. The effects were not fully reversible until the end of the 21-day observation period. Moreover, at 24, 48, and 72 h several eyes were encrusted with dry pus. Some necrosis of the conjunctivae was observed at 1 h (3/6 animals) and 4 h (5/6 animals). Hence, the test item was concluded to cause severe damage to the eyes.
Justification for classification or non-classification
The available data are reliable and suitable for classification. Based on this data, the registered substance meets the criteria to be classified for irreversible effects on the eye (Cat 1, H318) according to EC/1272/2008. Classification for skin irritation according to 67/584/EEC and EC/1272/2008 is not warranted.
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