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EC number: 228-846-8 | CAS number: 6362-80-7
- 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
In vivo skin irritation study (OECD TG 404): Not irritating
In vivo eye irritation study (OECD TG 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted according to GLP and guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Ranch Rabbits Ltd., Crawley Down, Sussex, England
- Age at study initiation: Approximately 11 to 13 weeks
- Weight at study initiation: 2.6 to 2.9 kg
- Housing: Housed individually in metal cages with perforated floors
- Diet: SDS Stanrab (P) rabbit diet ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature: 19°C
- Humidity: 30-70 %
- Air changes: Approximately 19 per hr
- Photoperiod: 12 hours artificial light (0700 - 1900 hours) in each 24 hour period - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 ml
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 14 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: Dorso-lumbar region
- Type of wrap if used: Elastoplast elastic adhesive dressing
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Washed with water
- Time after start of exposure: 4 hr
SCORING SYSTEM: Grading and scoring of dermal reactions were performed using the prescribed numerical scoring system as follows:
Erythema and eschar formation:
No erythema 0
Very slight erythema (barely perceptible) 1
Well defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to slight
eschar formation (injuries in depth) 4
Oedema formation:
No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well defined by
definitive raising) 2
Moderate oedema (raised approximately 1 millimetre) 3
Severe oedema (raised more than 1 millimetere
and extending beyond the area of exposure) 4
Any other lesion not covered by this scoring system, was described - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Remarks on result:
- other: Necrosis observed on day 4, but was ameliorated by day 9
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 11 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritant / corrosive response data:
- The numerical scores awared to the dermal reactions are given in table 1.
Well defined erythema with slight oedema was evident at all three treatment sites following the removal of the dressings (day 1)
Similar reactions persisted for a further 5 or 7 days before regressing in two animals, but progressed in the remaining animal by day 4 into necrotic foci with very slight or slight oedema.
Reactions ameliorated at all sites by days 7 or 9 with very slight erythema and oedema present. A similar level of response (with or without very slight oedema) persisted, but resolved by day 14.
Desquamation of the stratum corneum (sloughing) was seen in all animals by days 6/9 and was still visible at all sites on day 14. - Interpretation of results:
- other: not classified as irritating to skin under CLP
- Conclusions:
- The test substance is not considered to be irritating to skin according to CLP Regulation (EC) no. 1272/2008
Reference
Table 1: Dermal reactions elicited by the test substance
Rabbit number and sex |
E=erythema O=oedema |
Day |
|||||||||||||
1* |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
||
866♀ |
E O |
2 1 |
2 1 |
2 1 |
2 1 |
2 1 |
2B 1 |
1B 1 |
1B 1 |
1B 1 |
1B 0 |
1B 0 |
1B 0 |
1B 0 |
0B 0 |
867♀ |
E O |
2 1 |
2 1 |
2 1 |
2 1 |
2 1 |
2B 1 |
2B 1 |
2B 1 |
1B 1 |
1B 1 |
1B 0 |
1B 0 |
1B 0 |
0B 0 |
868♀ |
E O |
2 1 |
2 1 |
2 1 |
4A 2 |
4A 2 |
4A 1 |
4A 1 |
4A 1 |
1B 1 |
1B 0 |
1B 0 |
1B 0 |
1B 0 |
0B 0 |
* Approximately 30 minutes after removal of the dressing
A Necrosis
B Sloughing
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:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted according to GLP and guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Ranch Rabbits Ltd., Crawley Down, Sussex, England
- Age at study initiation: Approximately 12 to 14 weeks
- Weight at study initiation: 2.8 to 3.3 kg
- Housing: Housed individually in metal cages with perforated floors
- Diet: SDS Stanrab (P) rabbit diet ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature: 19°C
- Humidity: 30-70 %
- Air changes: Approximately 19 per hr
- Photoperiod: 12 hours artificial light (0700 - 1900 hours) in each 24 hour period - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 ml
- Duration of treatment / exposure:
- SIngle application.
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SCORING SYSTEM: Grading and scoring of the ocular lesions were performed using the prescribed numerical scoring system as follows
Opacity: degree of density (area most dense taken for reading)
Cornea
No ulceration or opacity 0
Scattered or diffuse areas of opacity (other
than slight dulling of normal lustre),
details of iris clearly visible 1
Easily discernible translucent areas, details
of iris slightly obscured 2
Nacrous areas, no details of iris visible,
size of pupil barely discernible 3
Opaque cornea, iris not discernible through
the opacity 4
Area of cornea involved
One quarter (or less) but not zero 1
Greater than one quarter, but less than half 2
Greater than half, but less than three quarters 3
Greater than three quarters, up to whole area 4
Iris
Normal 0
Markedly deepened rugae, congestion, swelling,
moderate circumcorneal hyperaemia or
injection, any of these or combination of
any thereof, iris still reacting to light
(sluggish reaction is positive) 1
No reaction to light, haemorrhage, gross
destruction (any or all of these) 2
Conjunctivae
Redness (refers to palpebral and bulbar
Conjunctivae excluding cornea and iris)
Blood vessels normal 0
Some blood vessels definitely hyperaemic
(injected) 1
Diffuse, crimson colour, individual vessels
not easily discernible 2
Diffuse beefy red 3
Chemosis (lids and/or nictating membranes)
No swelling 0
Any swelling above normal (includes nictating
membranes) 1
Obvious swelling with partial eversion of lids 2
Swelling with lids about half closed 3
Swelling with lids more than half closed 4
TOOL USED TO ASSESS SCORE: hand-slit lamp - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects seen
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects seen
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects seen
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects seen
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects seen
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects seen
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- 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:
- 0.67
- 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:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- 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
- Max. score:
- 4
- Reversibility:
- fully reversible within: 1 day
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 1 day
- Irritant / corrosive response data:
- The numerical scores awarded to the ocular reactions elicited by the test substance are given in Table 1.
No corneal damage or iridial inflammation was seen throughout the observation period.
A diffuse crimson-red colouration of the conjunctivae was seen in two animals at the one hour reading only.
All conjunctival responses had resolved two or three days after instillation - Interpretation of results:
- GHS criteria not met
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Not irritating to eyes according to the criteria set out in CLP Regulation (EC) no. 1272/2008
Reference
Table 1: Ocular reactions elicited by the test substance
Rabbit number and sex |
Region of Eye |
One hour |
Day after instillation |
|||||
1 |
2 |
3 |
4 |
7 |
||||
845♀ |
Cornea |
Density |
0 |
0 |
0 |
0 |
0 |
0 |
Area |
0 |
0 |
0 |
0 |
0 |
0 |
||
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
||
Conjunctiva |
Redness |
2 |
1 |
0 |
0 |
0 |
0 |
|
Chemosis |
1 |
1 |
0 |
0 |
0 |
0 |
||
857♀ |
Cornea |
Density |
0 |
0 |
0 |
0 |
0 |
0 |
Area |
0 |
0 |
0 |
0 |
0 |
0 |
||
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
||
Conjunctiva |
Redness |
1 |
1 |
1 |
0 |
0 |
0 |
|
Chemosis |
1 |
0 |
0 |
0 |
0 |
0 |
||
858♀ |
Cornea |
Density |
0 |
0 |
0 |
0 |
0 |
0 |
Area |
0 |
0 |
0 |
0 |
0 |
0 |
||
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
||
Conjuctiva |
Redness |
2 |
1 |
1 |
0 |
0 |
0 |
|
Chemosis |
1 |
0 |
0 |
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:Reliability 1 key study conducted according to GLP and OECD TG 404 (Liggett MP & McRae LA 1991). A 0.5ml aliquot of test substance was applied to the intact skin of three rabbits under a semi-occlusive dressing for 4 hours. Examination of treated skin was made on day 1 (approximately 30 minutes after removal of the dressings) and on days 2, 3 and 4 (equivalent to 24, 48 and 72 hours). According to the results the substance was considered to be non-irritating to skin.
Eye irritation:Reliability 1 key study conducted according to GLP and OECD TG 405 (Liggett MP & McRae LA 1991). A 0.1 ml aliquot of test substance was instilled into the eyes of three rabbits. Examination of the eyes was made after 1 hour and 1, 2, 3, 4 and 7 days after instillation. No corneal damage or iridial inflammation was seen throughout the observation period. Conjuctival responses were observed in two animals at one hour only and had resolved two or three days later. Based on the results of the study the test substance is not considered to be irritating to eyes.
Justification for classification or non-classification
According to the classification criteria of CLP Regulation Regulation (EC) No 1272/2008 the test substance is not considered to be irritating to skin or eyes.
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