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EC number: 231-335-2 | CAS number: 7493-74-5
- 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 (equivalent to OECD 404): not irritating
eye irritation (equivalent to OECD 405): not irritating
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:
- Nov 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Poor description of the test substance (no purity)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1981
- Deviations:
- yes
- Remarks:
- Poor description of the test substance (no purity).
- 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: 10 - 12 weeks
- Weight at study initiation: approx. 2 kg
- Housing: individually in grid bottomed metal cages
- Diet: SQC standard rabbit pellets (Special Diets Services, Witham, UK), ad libitum
- Water: mains drinking water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 5 - 24 (The system was set to maintain temperature within the range of 17 - 23 °C but the heating equipment failed during the acclimatisation period. Temperature was typically greater than 14 °C during the study period.)
- Humidity (%): 37 - 68
- Air changes (per hr): 6
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin areas
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 mL - Duration of treatment / exposure:
- 4 h
- Observation period:
- 7 days
Reading time points: 1, 24, 48 and 72 h and 7 days - Number of animals:
- 4
- Details on study design:
- TEST SITE
- Area of exposure: dorsal surface of the trunk
- Type of wrap: The test substance was placed over a 2.5 cm square of surgical lint. The lint square was placed either on the left or on the right flank. The lint patch was held in place by encircling the trunk with a length of adhesive bandage (Elastoplast) 10 cm wide.
REMOVAL OF TEST SUBSTANCE
- Washing: The skin was cleaned of residual test substance by gentle swabbing with cotton wool soaked in warm water.
- Time after start of exposure: 4 h
SCORING SYSTEM: Draize scoring system; Reaction to treatment considered to fall mid-way between the points described was scored as a fraction (i.e. 0.5, 1.5, 2.5, etc). - Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- #1 and #3
- Time point:
- other: mean after 24/48/72 h
- Score:
- 0.17
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- other: mean after 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: mean after 24/48/72 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- #2 and #3
- Time point:
- other: mean after 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- #1 and #4
- Time point:
- other: mean after 24/48/72 h
- Score:
- 0.17
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- Under the conditions of this skin irritation study in rabbits the test substance was not irritating to the skin.
Reference
Table 1. Results of the irritation study.
Observation time |
Rabbit no. |
|||||||
1 |
2 |
3 |
4 |
|||||
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
|
1 h |
0 |
0 |
0.5 |
0.5 |
0.5 |
0 |
0 |
0 |
24 h |
0.5 |
0.5 |
0.5 |
0 |
0.5 |
0 |
0.5 |
0.5 |
48 h |
0 |
0 |
0.5 |
0 |
0 |
0 |
0.5 |
0 |
72 h |
0 |
0 |
0.5 |
0 |
0 |
0 |
0 |
0 |
7 days |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Mean value 24 + 48 + 72 h |
0.17 |
0.17 |
0.5 |
0.0 |
0.17 |
0 |
0.33 |
0.17 |
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:
- 07 - 16 July 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- No information on purity was given.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1981
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Modified Federal Hazardous Substances Labelling Act Method (Federal Register, 1964, 29 13009)
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: at least 7 weeks
- Weight at study initiation: 1 - 2 kg
- Housing: singly before and during the test
- Diet: commercially available, pelleted diet, ad libitum
- Water: ad libitum - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The left eye was used as an untreated control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 mL - Duration of treatment / exposure:
- single application without washing
- Observation period (in vivo):
- 7 days
Reading time points: 15 min and 24, 48 and 72 h and 7 days - Number of animals or in vitro replicates:
- 3
- Details on study design:
- SCORING SYSTEM: Draize scoring system; Reaction to treatment considered to fall mid-way between the points
described was scored as a fraction (i.e. 0.5, 1.5, 2.5, etc).
TOOL USED TO ASSESS SCORE: slit lamp / fluorescein in one animal - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: mean after 24/48/72 h
- Score:
- 0.17
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #2 and #3
- Time point:
- other: mean after 24/48/72 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- other: mean after 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: mean after 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #2 and #3
- Time point:
- other: mean after 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- other: mean after 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- The test substance caused slight corneal opacities affecting up to 0.5 of the cornea in all 3 animals. One animal also had slight conjunctivitis. One animal healed by Day 2, two by Day 7.
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- Under the conditions of this eye irritation study in rabbits the test substance was not irritating to the eye.
Reference
Table 1. Results of the eye irritation study.
Animal |
Time (h) |
Conjunctivae |
Cornea |
Iris |
|
Redness |
Chemosis |
||||
1 |
15 min |
1 |
0 |
- |
- |
1 |
1 |
0 |
0.5 |
0 |
|
2 |
0 |
0 |
0 |
0 |
|
3 |
0 |
0 |
0 |
0 |
|
7 d |
0 |
0 |
0 |
0 |
|
Average 24+48+72 |
0.3 |
0 |
0.17 |
0 |
|
2 |
15 min |
1 |
0 |
- |
- |
1 |
0 |
0 |
0.5 |
0 |
|
2 |
0 |
0 |
0.5 |
0 |
|
3 |
0 |
0 |
0.5 |
0 |
|
7 d |
0 |
0 |
0 |
0 |
|
Average 24+48+72 |
0 |
0 |
0.5 |
0 |
|
3 |
15 min |
1 |
0 |
- |
- |
1 |
0 |
0 |
0.5 |
0 |
|
2 |
0 |
0 |
0.5 |
0 |
|
3 |
0 |
0 |
0.5 |
0 |
|
7 d |
0 |
0 |
0 |
0 |
|
Average 24+48+72 |
0 |
0 |
0.5 |
0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin
The skin irritation potential of the test substance was determined in a primary skin irritation/corrosion study equivalent or similar to OECD Guideline 404 and in compliance with GLP (1989). Four animals were treated with 0.5 mL undiluted test substance under semi-occlusive conditions for 4 h. Scoring of skin reactions (erythema and edema) was performed 1, 24, 48 and 72 h and 7 days after removal of the patch. Additionally to regular Draize scoring system slight effects were assessed with a value of 0.5. One hour after the four hour dosing period erythema (score 0.5) was apparent in two animals and edema (score 0.5) was apparent in one of these animals. Erythema (score 0.5) was observed at the treated skin of all animals 24 h after dosing. Edema (score 0.5) was observed in two animals. The incidence of irritant response had declined by the 48 h examination when erythema (score 0.5) remained in two animals. No irritation remained after 7 days. The mean irritation score over 24, 48 and 72 h was 0.3 for erythema and 0.1 for edema. Based on the results, the test substance was not irritating to the skin under the conditions of the test.
Eye
The eye irritation potential of the test substance was investigated in three albino rabbits equivalent or similar to OECD Guideline 405 (1980). 0.1 mL of the test substance was applied in one eye of each animal after pretreatment of the eyes with corneal anaesthetic. The other eye remained untreated and served as control. The eyes were examined and scored according to the Draize scoring system 15 min, 1, 2, 3 and 7 days after application. Additionally to regular Draize scoring system slight effects were assessed with a value of 0.5. A slight redness of the conjunctivae (score 1) of the treated eye was observed in one animal fully reversible within 2 days. The test substance caused slight corneal opacities (score 0.5) in all 3 animals fully reversible within 2 days in one animal and within 7 days in two animals. The mean scores for cornea at 24/48/72 for each animal were 0.17, 0.5 and 0.5, respectively. No effects on chemosis of conjunctivae or effects on iris were observed in any animal. Based on the results of this study, the test substance was not irritating to the eyes under the conditions of the test.
Justification for classification or non-classification
The available data on skin and eye irritation do not meet the criteria for classification according to Regulation (EC) 1272/2008, and are therefore conclusive but not sufficient for classification.
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