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EC number: 295-653-3 | CAS number: 92113-48-9
- 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
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 16 Apr - 18 May 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-guideline study.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bayerisches Landesamt für Gesundheit und Lebensmitelsicherheit, Landesinstitut für Arbeitsschutz und Produktsicherheit, München, Germany
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- There were hints that the substance is not a strong sensitiser, and the GPMT is the better method to detect weak sensitisers
- Species:
- guinea pig
- Strain:
- other: Crl:HA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Sulzfeld, Germany
- Age at study initiation: 4 weeks
- Weight at study initiation: 369-467 g
- Housing: The animals were kept in groups.
- Diet: Altromin 3122 maintenance diet for guinea pigs (preliminary test: lot no. 061211; main study: lot no. 261111), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55± 10
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12/12 - Route:
- intradermal and epicutaneous
- Vehicle:
- cotton seed oil
- Concentration / amount:
- Induction: 5% (intradermal), 100% (topical)
Challenge: 100% - Route:
- epicutaneous, occlusive
- Vehicle:
- cotton seed oil
- Concentration / amount:
- Induction: 5% (intradermal), 100% (topical)
Challenge: 100% - No. of animals per dose:
- Negative control group: 5 animals
Test group: 10 animals - Details on study design:
- RANGE FINDING TESTS:
Three animals were used in the range-finding tests. Animal 1 was treated intradermally with concentrations of 1%, 1.5%, 2.5%, and 5% of the test item dissolved in cotton seed oil. Animal 2 was treated topically with 50% and 100% of the test item dissolved in vaseline for 24 h. Animal 3 was treated equivalent to animal 2 for 48 h. Based on the results a concentration of 5% was chosen for the intradermal application of the main test. This concentration caused slight signs of irritation, without leading to systemic effects. A concentration of 100% was found to be the highest concentration that did not cause any signs of irritation after topical treatment.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous)
- Exposure period: single injection (intradermal) and 48 h (epicutaneous)
- Test groups:
Intradermal (3 pairs of injections):
Injection 1: a 1:1 mixture (v/v) FCA/physiological saline 0.9% NaCl
Injection 2: test substance (5%) in cotton seed oil
Injection 3: test substance (5%) in a 1:1 mixture (v/v) FCA/physiological saline 0.9% NaCl
Epicutaneous: 100% test substance (0.5 g)
- Control group:
Intradermal (3 pairs of injections):
Injection 1: a 1:1 mixture (v/v) FCA/physiological saline 0.9% NaCl
Injection 2: 100% cotton seed oil
Injection 3: a 50% (v/v) formulation of cotton seed oil in a 1:1 mixture (v/v) FCA/physiological saline 0.9% NaCl
Epicutaneous: 100% vaseline
- Site: shoulder region
- Frequency of applications: every 7 days
- Duration: day 0-7
- Concentrations: intradermal 5%, epicutaneous 100%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: 20
- Exposure period: 24 h
- Test groups: 0.5 g of test item (100%)
- Control group: 0.5 g of test item (100%)
- Site: left flank (test item), right flank (vehicle)
- Concentrations: 100%
- Evaluation (hr after challenge): 24 and 48 h - Challenge controls:
- The control group is actually a challenge control.
- Positive control substance(s):
- yes
- Remarks:
- reliability check with mercaptobenzothiazole
- Positive control results:
- The positive control substance (induction 1: 15%; induction 2: 25%; challenge: 15% mercaptobenzothiazole) induced positive reactions in 10/10 animals (100%), thus meeting the reliability criteria for the GPMT.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5%. No with. + reactions: 2.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5%. No with. + reactions: 2.0. Total no. in groups: 10.0.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
Reference
Summary of sensitisation after challenge in comparison to control animals
|
Erythema reaction (grade 0-3) |
Oedema reaction (grade 0-3) |
|
||||||
|
E0 |
E1 |
E2 |
E3 |
O0 |
O1 |
O2 |
O3 |
Sensitised animals (%) |
Treated animals after 24 h |
8 |
2 |
- |
- |
10 |
- |
- |
- |
20 |
Treated animals after 48 h |
8 |
2 |
- |
- |
10 |
- |
- |
- |
20 |
Controls after 24 h |
5 |
- |
- |
- |
5 |
- |
- |
- |
0 |
Controls after 48 h |
5 |
- |
- |
- |
5 |
- |
- |
- |
0 |
Absolute body weights in g (Test group)
Test group |
||||||||||
Date |
Animal No. |
|||||||||
|
T1 |
T2 |
T3 |
T4 |
T5 |
T6 |
T7 |
T8 |
T9 |
T10 |
2012-04-24 |
377 |
396 |
383 |
402 |
383 |
441 |
414 |
452 |
415 |
455 |
2012-05-18 |
488 |
506 |
522 |
490 |
500 |
573 |
528 |
626 |
543 |
585 |
Weight gain |
111 |
110 |
139 |
88 |
117 |
132 |
114 |
164 |
128 |
130 |
Absolute body weights in g (Control group)
Control group |
|||||
Date |
Animal No. |
||||
|
T1 |
T2 |
T3 |
T4 |
T5 |
2012-04-24 |
467 |
464 |
435 |
417 |
369 |
2012-05-18 |
618 |
612 |
605 |
564 |
470 |
Weight gain |
151 |
148 |
170 |
147 |
101 |
Grading of reactions in the preliminary test (intradermal)
Animal No. |
Conc. (%) |
E (24 h) |
O (24 h) |
E (48 h) |
O 48 (h) |
E (72 h) |
O (72 h) |
1 |
5 |
E1 |
O1 |
E1 |
O1 |
E1 |
O1 |
|
2.5 |
E1 |
O1 |
E1 |
O1 |
E1 |
nsf |
1 |
1.5 |
E1 |
nsf |
E1 |
nsf |
E1 |
nsf |
|
1 |
E1 |
nsf |
E1 |
nsf |
E1 |
nsf |
E: erythema (grade 0 -3); O: Oedema (grade 0 -3); nsf: no specific findings
Grading of reactions in the preliminary test (epicutaneous)
Animal No. |
Conc. (%) |
E (24 h) |
O (24 h) |
E (48 h) |
O 48 (h) |
E (72 h) |
O (72 h) |
2 (24-h exposure) |
100 |
nsf |
nsf |
nsf |
nsf |
nsf |
nsf |
50 |
nsf |
nsf |
nsf |
nsf |
nsf |
nsf |
|
1(48-h exposure) |
100 |
nsf |
nsf |
nsf |
nsf |
nsf |
nsf |
50 |
nsf |
nsf |
nsf |
nsf |
nsf |
nsf |
E: erythema (grade 0 -3); O: Oedema (grade 0 -3); nsf: no specific findings
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
A guinea pig maximisation test performed according to OECD 406 and in compliance with GLP, is available for assessment of the skin sensitising properties ofFatty acids, C14-18 and C16-18-unsatd., mixed esters with castor oil, castor oil fatty acids, 2-ethylhexanoic acid and 2,2-bis(hydroxymethyl)-1-butanol (Stelter 2012, 2012). 10 animals of the test group were induced with 5% (intradermally) and 100% (topically) test substance. The challenge application was performed at day 20 with 100% test substance. In addition 5 control animals were induced with cotton seed oil (intradermally) and vaseline (topically). The challenge application was performed at day 20 with 100% test substance. In the control group, no reactions were observed 24 and 48 h after the challenge application (0/5). In the test group, 2/10 animals showed a reaction at 24 and 48 h (erythema grade 1). For a positive result the criterion of = 30% positive reactions must be fulfilled. As only 20% positive reactions were observed (2/10), the test substance is considered to be not skin sensitising.
Migrated from Short description of key information:
Skin sensitisation (OECD 406): not sensitising
Justification for selection of skin sensitisation endpoint:
There is only one study available.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on substance specific study, the available data on the skin sensitisation potential do not meet the classification criteria according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.
There are no data available on respiratory sensitisation.
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