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EC number: 268-452-3 | CAS number: 68092-28-4
- 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
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Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP Guideline study. Reliability of 2 given since the data is based on read across, not the target substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- A valid guinea pig maximisation test was already available. It was considered un-ethical to re-run to the LLNA method
Test material
- Reference substance name:
- Diethanolamine
- IUPAC Name:
- Diethanolamine
- Reference substance name:
- 2,2'-iminodiethanol
- EC Number:
- 203-868-0
- EC Name:
- 2,2'-iminodiethanol
- Cas Number:
- 111-42-2
- Molecular formula:
- C4H11NO2
- IUPAC Name:
- 2,2'-iminodiethanol
- Test material form:
- liquid
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Himalayan
- Sex:
- female
- Details on test animals and environmental conditions:
- - Source: BRL, Fuellingsdorf, Switzerland
- Age at study initiation: 8 weeks
- Weight at study initiation: 324 - 342 g (mean)
- Diet: ad libitum
- Water: ad libitum
- Acclimation period:
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- physiological saline
- Concentration / amount:
- Range finding tests: intradermal (1, 3, 5 %); dermal (25, 50, 75, 100 %)
Induction: intradermal (5 % in saline and 5 % in Saline/FCA); dermal (25, 50, 75,100 %)
Challenge: dermal (25 %)
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- Range finding tests: intradermal (1, 3, 5 %); dermal (25, 50, 75, 100 %)
Induction: intradermal (5 % in saline and 5 % in Saline/FCA); dermal (25, 50, 75,100 %)
Challenge: dermal (25 %)
- No. of animals per dose:
- 40 femals in total and additional 6 females for pretests;
10 animals for control group 1
10 animals for control group 2
20 animals for test group
2 females for the intracutaneous pretest
4 females for the epicutaneous pretest. - Details on study design:
- For the identification of irritant test substance concentration suitable for the induction phase, intradermal injections (0.1 mL/site) were made into the clipped flank of 2 animals at concentrations of 1, 3 and 5 % dissolved in physiological saline. The dermal reactions were assessed 24 hours later. For epidermal applications patches of filter paper (2 x 2 cm) were saturated with the undiluted test substance (100 %) and with preparations in physiological saline of 25, 50, 75 % and were applied occlusively to the clipped and shaved skin of 4 animals. The dressings were removed after 24 hours and investigated for erythema and edema and re-investigated after 48 hours.
MAIN STUDY
A1. INDUCTION EXPOSURE (intrademal injections)
- No. of exposures: 3 pairs of intradermal injections (0.1 mL/site)
- Exposure period: 24 hours
- Test groups: 1) Freund's complete adjuvant 50:50 with bi-distilled water.
2) The test article, diluted to 5 % with physiological saline.
3) The test article at the concentration used in (2), emulsified in a 50:50 mixture of Freund's complete adjuvant and the vehicle ued i n (2) .
- Control group: 1) Freund's complete adjuvant 50:50 with bi-distilled water.
2) Vehicle used in (2) for test group .
3) Freund's complete adjuvant 50:50 with bi-distilled water.
- Site: clipped dorsal skin
- Frequency of applications:
- Duration: 24 h after injections reactions were assessed
A2. INDUCTION EXPOSURE (epidermal application)
- No. of exposures: single exposure with Patches of 2 x2 cm in size saturated with the test compound at different concentrations
- Exposure period: 24 hours
- Frequency of applications: epicutaneous application was made one week after intradermal induction
- Duration: 72 h (24h exposure, then substance removal and first reading; second and third readings 24h and 48h after substance removal)
- Concentrations: 100, 75, 50, 25 %
B. CHALLENGE EXPOSURE
- No. of exposures: 2 patches of 2 x2 cm in size saturated with the test compound were applied to the right and the left flank skin
- Day(s) of challenge: two weeks after the epidermal induction application
- Exposure period: 24 h
- Test groups: all test groups challenged with the test substance
- Control group: control group 1 challenged with the test substance, control group 2 left untreated
- Site: shaved flank skin
- Concentrations: non-irritant concentration (25 % in saline)
- Evaluation (hr after challenge): immediately after patch removal, 24h and 48h later
OTHER: Scoring
The reactions were scored according to the following numerical grading system according to Draize:
Erythema and eschar formation:
0 No erythema
1 Very slight erythema (barely perceptible)
2 Well-defined erythema
3 Moderate to severe erythema
4 Severe erythema (beet redness) to slight eschar formation (injuries in depth)
Edema formation:
0 No edema
1 Very slight edema (barely perceptible)
2 Slight edema (edges of area well-defined by definite raising)
3 Moderate edema (raised approximately 1 mm)
4 Severe edema (raised more than 1 mm and extending beyond the area of exposure) - Challenge controls:
- 1) Freund's complete adjuvant 50:50 with bi-distilled water.
2) Vehicle used in (2) for test group.
3) Freund's complete adjuvant 50:50 with bi-distilled water.
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Clinical observations:
- erythema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. No with. + reactions: 2.0. Total no. in groups: 20.0. Clinical observations: erythema.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Clinical observations:
- erythema
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. No with. + reactions: 1.0. Total no. in groups: 20.0. Clinical observations: erythema.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Group:
- positive control
- Remarks on result:
- not measured/tested
Any other information on results incl. tables
Results
of pretest:
Based on the
reactions of the pretest, the concentration of 5% was selected for
intradermal injection for the main study
Based
on the reactions of the pre-test with regards to epidermal application,
the concentration selected for the induction was 75 % and for the
challenge procedure was 25 %.
Results of main test:
No mortalities
or toxic signs occurred.
Control group:
No positive skin reactions were evident after 1st challenge neither with
when treated with physiological saline nor with 25 % Diethanolamine.
Test group:
Only 2/20 (10 %) showed erythema findings at 24 h readings, declining to
1/20 (5 %) at 48 h reading when treated with 25 % Diethanolamine. No
further findings were noted.
Summary of skin reactions after challenge exposure:
Readings: |
24 h |
48 h |
Control groups |
||
75 % epidermal DEA during induction |
0/10 |
0/10 |
Phys. Saline during induction |
0/10 |
0/10 |
Test group |
||
25 % DEA |
2/20 |
1/20 |
Phys. saline |
0/20 |
0/20 |
Body weights:
The body weight gain of the animals was not affected adversely during the study.
Systemic Symptoms:
No systemic symptoms were observed during the study.
Applicant's summary and conclusion
- Interpretation of results:
- other: GHS criteria not met
- Conclusions:
- Not skin sensitising
- Executive summary:
The potential of the test material to cause skin sensitisation was investigated in a guinea-pig maximisation test conducted in accordance with the standardised guideline OECD 406 under GLP conditions.
Twenty female Himalayan guinea-pigs were exposed to the test material. The concentrations used in the induction phase of the study were 5 % in saline and 5 % in saline/FCA for the intradermal and 25, 50, 75 and 100 % in physiological saline for the topical application.
In the challenge application, the animals were exposed to the test material at 25 % v/v in physiological saline.
No signs of ill health or toxicity were observed throughout the study. The test material elicited dermal reactions similar to those seen in the control animals.
Under the conditions of this study, the test material did not produce evidence of skin sensitisation and therefore requires no classification in accordance with EU criteria.
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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