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EC number: 620-540-6 | CAS number: 1218787-32-6
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- September 1989 - January 1990
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Substance: CESIO 33. No data on batch no. and composition. Basic data given according to guidelines/standards.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- 6 animals rather than 3 animals were used
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2,2'-(C16-18 (evennumbered, C18 unsaturated) alkyl imino) diethanol
- EC Number:
- 620-540-6
- Cas Number:
- 1218787-32-6
- Molecular formula:
- No molecular formula
- IUPAC Name:
- 2,2'-(C16-18 (evennumbered, C18 unsaturated) alkyl imino) diethanol
- Test material form:
- liquid
- Details on test material:
- - Chemical name: 2,2'-(C16-18 (evennumbered, C18 unsaturated) alkyl imino) diethanol
- EC number: 620-540-6
To the best of knowledge, the sample used is representative to the boundary composition shared and agreed by each registrant
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd., Moston, UK
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2-3 kg
- Housing: individually in suspended metal cages
- Diet (e.g. ad libitum): ad lib
- Water (e.g. ad libitum): ad lib
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 13-21
- Humidity (%): 47-69
- Air changes (per hr): ca. 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 26 September 1989 To: 4 January 1990 (for all 17 compounds)
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml - Duration of treatment / exposure:
- 4 hours (Exposure of 3 min was also preformed but no data reported).
- Observation period:
- up to 14 days
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm gauze patch
- % coverage: not indicated
- Type of wrap if used: gauze patch was secured with surgical adhesive tape (2.5 x 4 cm); the trunk was wrapped in an
elasticated corset.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, by gently swabbing with cotton wool soaked in diethyl ether
- Time after start of exposure: immediately following patch removal
SCORING SYSTEM:
EVALUATION OF SKIN REACTIONS
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
definite raising) 2
Moderate oedema (raised approximately 1 mm) 3
Severe oedema (raised more than 1 mm and
extending beyond area of exposure) 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks on result:
- other: scar tissue
- Remarks:
- At 72 hrs unable to evaluate degree of erythema or oedema due to presence of other adverse dermal reactions
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other:
- Remarks:
- At 72 hrs unable to evaluate degree of erythema or oedema due to presence of other adverse dermal reactions
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks on result:
- other:
- Remarks:
- At 72 hrs unable to evaluate degree of erythema or oedema due to presence of other adverse dermal reactions
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3.5
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other:
- Remarks:
- At 72 hrs unable to evaluate degree of erythema or oedema due to presence of other adverse dermal reactions
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks on result:
- other:
- Remarks:
- From day 7 unable to evaluate degree of erythema or oedema due to presence of other adverse dermal reactions
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 3.67
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other:
- Remarks:
- From day 7 unable to evaluate degree of erythema or oedema due to presence of other adverse dermal reactions
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks on result:
- other:
- Remarks:
- From day 7 unable to evaluate degree of erythema or oedema due to presence of other adverse dermal reactions
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 3.67
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other:
- Remarks:
- From day 7 unable to evaluate degree of erythema or oedema due to presence of other adverse dermal reactions
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks on result:
- other:
- Remarks:
- From day 7 unable to evaluate degree of erythema or oedema due to presence of other adverse dermal reactions
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 3.67
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other:
- Remarks:
- From day 7 unable to evaluate degree of erythema or oedema due to presence of other adverse dermal reactions
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 2.5
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks on result:
- other:
- Remarks:
- From 72 hrs unable to evaluate degree of erythema or oedema due to presence of other adverse dermal reactions
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 3.5
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other:
- Remarks:
- From 72 hrs unable to evaluate degree of erythema or oedema due to presence of other adverse dermal reactions
- Irritant / corrosive response data:
- Severe dermal responses were produced. The adverse skin reactions sometimes precluded accurate evaluation of erythema and
oedema. Very slight to well -defined erythema, haemorrhage of the dermal capillaries and slight to moderate oedema were noted
one hour after patch removal. The responses increased in severity and at subsequent observations were identified as well -
defined and moderate to severe oedema, haemorrhage of the dermal capillaries, blanching of the skin, a brown discolouration of theepidermis, scabbing, loss of skin flexibility, a straw-coloured crust (possible hyperkeratinisation), desquamation, thickening of the
skin, reduced re-growth of fur and glossy skin. Scar tissue, indicative of dermal corrosion was noted in five out of six rabbits. - Other effects:
- No data.
Any other information on results incl. tables
Summary of dermal irritation (following 4-h application)
Animal no. |
Effect |
Hour |
Days after application |
Mean score erythema (24/48/72 h) |
Mean score oedema (24/48/72 h) |
||||||
1 |
1 |
2 |
3 |
7 |
14 |
||||||
25 M |
Erythema Oedema |
2 2 |
3 4 |
2 4 |
? ? |
? ? |
? ? |
2.5? |
4? |
||
28 F |
Erythema Oedema |
2 2 |
3 4 |
3 3 |
? ? |
? ? |
0 ? |
3? |
3.5? |
||
31 M |
Erythema Oedema |
2 3 |
3 4 |
3 4 |
3 3 |
? ? |
? ? |
3 |
3.67 |
||
33 M |
Erythema Oedema |
2 2 |
3 4 |
3 4 |
3 3 |
? ? |
? ? |
3 |
3.67 |
||
73 M |
Erythema Oedema |
2 2 |
2 4 |
2 4 |
2 3 |
? ? |
? 0 |
2 |
3.67 |
||
134 F |
Erythema Oedema |
1 2 |
2 4 |
3 3 |
? ? |
? ? |
? ? |
2.5? |
3.5? |
||
Mean all animals |
2.67? |
3.67? |
? Unable to evaluate degree of erythema or oedema due to presence of other adverse dermal reactions
At day 7: scabs, dry straw-coloured crust, sometimes flaking from the skin (possible hyperkeratinisation)
At day 14: desquamation, thickening of the skin, scabs, scar tissue, reduced re-growth of fur, skin glossy in appearance (keratinolysis)
Applicant's summary and conclusion
- Interpretation of results:
- Category 1C (corrosive) based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- The test material was considered to be corrosive (Category 1C) to the rabbit skin according to OECD-GHS. This was essentially
based on the formation of scar tissue, indicative of dermal corrosion, in 5 out of 6 rabbits. - Executive summary:
A study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The method used followed the recommendations of the OECD Guidelines for Testing of Chemicals No. 404 "Acute Dermal Irritation/Corrosion" and Method B4 of the EC. A single
4 -hour, semi-occluded application of the test material to the intact skin of six rabbits produced severe dermal responses. Scar tissue, indicative of dermal corrosion was noted in 5 out of 6 rabbits 14 days after application. The test material was therefore classified as corrosive (Category 1C) to the rabbit skin, according to OECD/GHS criteria.
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