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EC number: - | CAS number: -
- 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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1992-06-18 to 1992-07-12
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- May 12, 1981
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- A valid GPMT conducted according to guideline is available, which is reliable without restrictions and adequate for classification and labelling purposes. Potency estimation is not mandatory when existing guideline and GLP conforming data are available, which were conducted before the new annex of the REACH Regulation entered into force. Moreover, no indication for skin sensitisation was observed in this study, thus, no dose response information is needed. For this reason and for reasons of animal welfare no additional LLNA was conducted.
Test material
- Test material form:
- other: paste
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright white Bor:DHPW (SPF)
- Sex:
- male/female
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- intradermal injection: 5 % in aqua ad inject
topical application: 25 % in aqua ad inject - Day(s)/duration:
- intradermal: day 0 / epicutaneous: 7 days after intradermal for 48 h
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 10% in aqua ad inject.
- Day(s)/duration:
- day 21 / 24 h exposure
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 20 (10 male, 10 female)
- Details on study design:
- RANGE FINDING TESTS:
- Intradermal injection:
The test article was diluted with aqua ad inject. and Freund's complete adjuvant (FCA; Sigma, 8024 Deisenhofen) to give a final concentration of 5 %.
Two animals were employed for the concentration tested, skin reactions were recorded 48 h after treatment.
- Dermal Application:
The test article was used undiluted. A closed patch exposure was effected by means of an occlusive bandage. Since this maximum concentration proved irritating, lower concentrations (75, 50, 25, 10 %) were tested. Ten animals were employed and skin reactions were recorded 48 h post applicationem.
MAIN STUDY
A. INDUCTION EXPOSURE (day 0)
- First stage -an area of 4 x 6 cm over the shoulders was clipped short with electric clippers and cleaned with 70 % (v/v) ethanol. Three pairs of intradermal injections were then made symmetrically in two rows on either side of the spine:
-- Test group:
1. 0.1 ml FCA 50 % (w/w) diluted in aqua ad inject.
2. 0.1 ml test article diluted in aqua ad inject (final concentration: 5 %)
3. 0.1 ml test article diluted in FCA /aqua ad inject (final concentration: 5 %)
-- Control group:
1. 0.1 ml FCA 50 % (w/w) diluted in aqua ad inject
2. 0.1 ml aqua ad inject. (undiluted)
3. 0.1 ml aqua ad inject 50 % (w/w) diluted in FCA
-- Second stage (day 7)
- 7 days after the intradermal injections the dermal application was initiated subsequent to reclipping of the area 24 hours before application of the test article at the highest concentration producing mild to moderate irritation, i.e. (25 % in aqua ad. inject). The test article was spread in a thick layer [to saturation] over a 4 x 5 cm patch (filter paper). The latter was firmly secured over the previous injection sites by an occlusive dressing for 48 h.
Control animals received a patch loaded with the vehicle alone.
B. CHALLENGE EXPOSURE (day 21)
Both control and test animals were subjected to a challenge exposure 14 days after the second stage of induction. The challenge test was performed on a 5 x 5 cm clipped and shaved area on each flank. The maximal non-irritating concentration of the test article (10 % in aqua ad iniect.) was applied to the left flank and the vehicle to the right using the patch technique described. In each case the duration of exposure was 24 h under an occlusive dressing. 24 and 48 h after patch removal, allergic responses were evaluated on a numerical scale according to Draize.
GRADING SYSTEM
Dermal reactions graded for erythema and edema according to grading scale:
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
No edema: 0
Very slight edema (barely perceptible): 1
Slight edema (edges well defined by raising): 2
Moderate edema (raised approx 1 mm): 3
Severe edema (raised > 1 mm; beyond area of exposure): 4 - Positive control substance(s):
- yes
- Remarks:
- 2,4 dinitrochlorobenzene (extreme sensitizer) and benzocaine (moderate sensitizer) are tested periodically. The last test with an acceptable level of response to each of these substances was performed in April 1992.
Results and discussion
- Positive control results:
- 2,4 dinitrochlorobenzene (extreme sensitizer) and benzocaine (moderate sensitizer) are tested periodically. The last test with an acceptable level of response to each of these substances was performed in April 1992.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 1st reading
- Group:
- positive control
- Remarks on result:
- other: valid, but not further detailed in the study report
Any other information on results incl. tables
RESULTS
Pilot study (range finding):
- Intradermal: No specific findings were observed.
- Dermal:
-- 100, 75 and 50 %: Partly well-defined erythema and slight oedema with induration of the treated areas were observed.
-- 25 %: Slight to well-defined erythema were observed.
-- 10 %: No skin reactions were observed, highest non-irritant concentration.
Main study:
Signs of irritation during induction:
At a concentration of 25 % slight to well-defined erythema and oedema were observed.
Challenge (conc. of test substance: 10 %, left flank) : The sensitization rate at 24 h and at 48 h was 0 %.
No reactions observed in control and test animals at 24 or 48h.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test article "partially unsaturated TEA-Esterquat" is considered to be a non-sensitizer in this study.
- Executive summary:
In a dermal sensitization study according to OECD Guideline 406, May, 12 1981 with partially unsaturated TEA-Esterquat (a.i. 90 %, in isopropanol 10 %) diluted in water young adult Pirbright white guinea pigs (10 male, 10 female) were tested using the MAXIMIZATION TEST method.
Intradermal induction was performed with a 5 % test substance concentration. After dermal induction with 25 % solution of test substance, slight to well defined erythema and oedema was observed. None of the animals of the test group or control group showed any positive skin reactions after challenge treatment with a non-irritating test article concentration of 10 % in water. The sensitization rate at 24 h and at 48 h was 0 %.
The test article is considered to be a non-sensitizer in this study.
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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