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EC number: 233-520-3 | CAS number: 10213-78-2
- 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
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- Nanomaterial pour density
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- Nanomaterial radical formation potential
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- Endpoint summary
- Stability
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- 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:
- 20 April 2010 and 04 May 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2,2'-(C16-18 (evennumbered) alkyl imino) diethanol
- EC Number:
- 620-539-0
- Cas Number:
- 1218787-30-4
- Molecular formula:
- No molecular formula
- IUPAC Name:
- 2,2'-(C16-18 (evennumbered) alkyl imino) diethanol
- Test material form:
- other: liquid/paste
- Details on test material:
- - Chemical name: 2,2'-(C16-18 (evennumbered) alkyl imino) diethanol
- EC number: 620-539-0
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 ANIMAL
- Source:
One New Zealand White rabbit supplied by an accredited supplier.
- Age at study initiation:
Twelve to twenty weeks old.
- Weight at study initiation:
At the start of the study the animal weighed 2.44 kg.
- Housing:
The animal wasindividually housed in a suspended cage.
- Diet (e.g. ad libitum):
Certified Rabbit Diet. ad libitum.
- Water (e.g. ad libitum):
ad libitum
- Acclimation period:
At least Five days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C):
17 to 23°C
- Humidity (%):
30 to 70%
- Air changes (per hr):
The rate of air exchange was at least fifteen changes per hour.
- Photoperiod (hrs dark / hrs light):
The lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: Moistened sufficiently with 0.5 ml of distilled water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit):
0.5 g
- Concentration (if solution):
Not applicable.
VEHICLE
Not applicable.
- Concentration (if solution):
Not applicable.
- Lot/batch no. (if required):
Not given in study report. - Duration of treatment / exposure:
- 3-minutes, 1-hour and 4 hours
- Observation period:
- 14 days
- Number of animals:
- 1
- Details on study design:
- TEST SITE
- Area of exposure:
On the day of the test a suitable test site was selected on the back of the rabbit.
- % coverage:
Not given in study report.
- Type of wrap if used:
Test material was introduced under a 2.5 cm x 2.5 cm cotton gauze patch and placed in position on the shorn skin.
REMOVAL OF TEST SUBSTANCE
- Washing (if done):
Any residual test material removed by gentle swabbing with cotton wool soaked in distilled water.
- Time after start of exposure:
3-minute, 1-hour and 4 hours.
SCORING SYSTEM:
Approximately one hour following the removal of the patches, and 24, 48 and 72 hours later, the test sites were examined for evidence of primary irritation and scored according to the following scale (table below).
Additional observations were made on Days 7 and 14 to assess the reversibility of skin reactions.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- Erythema/Eschar Formation
- Basis:
- animal #1
- Remarks:
- 69116 male
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks:
- within 14 days
- Remarks on result:
- other: Brown discolouration of the epidermis, loss of skin elasticty and loss of skin flexibility noted at the 24, 48 and 72-Hour observations. A hardened light brown coloured scab was noted at the 7-Day observation.
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- 69116 male
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks:
- Fully reversible in 14-days
- Irritant / corrosive response data:
- RESULTS
Skin Reactions
3-Minute Exposure Period
The scores for erythema/eschar and oedema are given in Table 1.
Very slight erythema was noted at the treated skin site at the 24, 48 and 72 Hour observations.
The treated skin site appeared normal at the 7-Day observation.
1-Hour Exposure Period
The scores for erythema/eschar and oedema are given in Table 1.
Well-defined erythema and very slight oedema were noted at the treated skin site at the 24, 48 and 72 Hour observations. Crust formation, preventing accurate evaluation of erythema and oedema, was noted at the treated skin site at the 7 Day observation.
The treated skin site appeared normal at the 14 Day observation.
4-Hour Exposure Period
The scores for erythema/eschar and oedema are given in Table 2.
Very slight erythema was noted at the treated skin site one hour after patch removal. Well-defined erythema, slight oedema, light brown discolouration and loss of skin elasticity and flexibility were noted at the treated skin site at the 24, 48 and 72-Hour observations. A hardened, light brown coloured scab, preventing accurate evaluation of erythema and oedema, was noted at the treated skin site at the 7 Day observation.
The treated skin site appeared normal at the 14 Day observation.
Any other information on results incl. tables
The individual scores for erythema/eschar and oedema are given in the folowing tables.
IndividualSkin Reactions - 3 -Minute and 1 -Hour exposures
Skin Reaction |
Observation Time |
Individual Scores - Rabbit Number and Sex |
|
69116Male |
|||
3-Minute Exposure |
1-Hour Exposure |
||
Erythema/Eschar Formation |
Immediately |
0 |
0 |
1 Hour |
0 |
0 |
|
24 Hours |
1 |
2 |
|
48 Hours |
1 |
2 |
|
72 Hours |
1 |
2 |
|
7 Days |
0 |
?eCf |
|
14 Days |
0 |
0 |
|
Oedema Formation |
Immediately |
0 |
0 |
1 Hour |
0 |
0 |
|
24 Hours |
0 |
1 |
|
48 Hours |
0 |
1 |
|
72 Hours |
0 |
1 |
|
7 Days |
0 |
?od |
|
14 Days |
0 |
0 |
Cf= Crust formation
?e = Adverse skin reactions prevent accurate evaluation of erythema
?od = Adverse skin reactions prevent accurate evaluation of oedema
Table2 Skin ReactionsFollowing 4-Hour Exposure
Skin Reaction |
Observation Time |
Individual Scores – Rabbit Number and Sex |
69116Male |
||
Erythema/Eschar Formation |
Immediately |
0 |
1 Hour |
1 |
|
24 Hours |
2BrLeLf |
|
48 Hours |
2BrLeLf |
|
72 Hours |
2BrLeLf |
|
7 Days |
?eSp |
|
14 Days |
0 |
|
Oedema Formation |
Immediately |
0 |
1 Hour |
0 |
|
24 Hours |
2 |
|
48 Hours |
2 |
|
72 Hours |
2 |
|
7 Days |
?od |
|
14 Days |
0 |
|
Sum of 24 and 72-hour Readings (S) : 8 |
||
Primary Irritation Index (S/2) : 8/2 = 4.0 |
||
Classification : MODERATE IRRITANT |
Br= Light brown discolouration of the epidermis
Le = Loss of skin elasticity
Lf = Loss of skin flexibility
Sp = Hardened light dark brown coloured scab
?e = Adverse skin reactions prevent accurate evaluation of erythema
?od = Adverse skin reactions prevent accurate evaluation of oedema
The test material produced a primary irritation index of 4.0 and was classified as a MODERATE IRRITANT to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.
Interpretation of Results
Calculation of Primary Irritation Index and Grading of Irritancy Potential Using the Draize Scheme
The scores for erythema and oedema at the 24 and 72-hour readings were totalled for the three test rabbits (12 values) and this total was divided by six to give the primary irritation index of the test material. The test material was classified according to the following scheme devised by Draize J H (1959) "Dermal Toxicity" In: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics. Association of Food and Drug Officials of the,,, p.47:
Primary Irritation Index |
Classification of Irritancy |
0 |
Non-irritant |
> 0 to 2 |
Mild irritant |
> 2 to 5 |
Moderate irritant |
> 5 to 8 |
Severe irritant |
If irreversible alteration of the dermal tissue is noted in any rabbit, as judged by the Study Director, which include ulceration and clear necrosis or signs of scar tissue, the test material is classified as corrosive to rabbit skin. Classification according to Draize may, therefore, not be applicable.
Applicant's summary and conclusion
- Interpretation of results:
- moderately irritating
- Remarks:
- Migrated information EU - R38 "Irritating to skin". Criteria used for interpretation of results: other: EU and Draize
- Conclusions:
- The test material produced a primary irritation index of 4.0 and was classified as a MODERATE IRRITANT to rabbit skin according to the Draize classification scheme (based on one rabbit only). No corrosive effects were noted.
The test material produced positive criteria and was considered to be an irritant according to EU labelling regulations Commission Directive 2001/59/EC. The symbol “Xi”, the indication of danger “Irritant” and the risk phrase R 38 “IRRITATING TO SKIN” are therefore required. This corresponds to a CLP/GHS classification of Category 2 for skin irritation. - Executive summary:
Introduction.
The study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The method was designed to meet the requirements of the following:
§ OECD Guidelines for the Testing of Chemicals No. 404 “Acute Dermal Irritation/Corrosion” (adopted 24 April 2002)
§ Method B4 Acute Toxicity (Skin Irritation) of Commission Regulation (EC) No. 440/2008
Results.
3-Minute and 1-Hour semi-occluded applications of the test material to the intact skin of one rabbit produced no corrosive effects.
A single 4-Hour, semi-occluded application of the test material to the intact skin of one rabbit produced well-defined erythema and slight oedema. Other skin reactions noted were light brown discolouration of the epidermis, loss of skin elasticity and flexibility and hardened, light brown coloured scab (preventing accurate evaluation of erythema and oedema). The treated skin site appeared normal at the 14‑Day observation.
Conclusion.
The test material produced a primary irritation index of 4.0 and was classified as a MODERATE IRRITANT to rabbit skin according to the Draize classification scheme (based on one rabbit only). No corrosive effects were noted.
The test material produced positive criteria and was considered to be an irritant according to EU labelling regulations Commission Directive 2001/59/EC. The symbol “Xi”, the indication of danger “Irritant” and the risk phrase R 38 “IRRITATING TO SKIN” are therefore required.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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