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EC number: 202-075-7 | CAS number: 91-53-2
- 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
- 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Remarks:
- Peer-reviewed assessment report (attached in section 13)
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-5 (Acute Dermal Irritation)
- Version / remarks:
- US EPA FIFRA § 81-5
- Deviations:
- yes
- Remarks:
- Purity of the test compound was not determined by the laboratory prior to conduct of the test.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- not applicable
- GLP compliance:
- yes
- Remarks:
- self-certified to US EPA regulations at 40 CFR Parts 160 and 792
Test material
- Reference substance name:
- Ethoxyquin
- EC Number:
- 202-075-7
- EC Name:
- Ethoxyquin
- Cas Number:
- 91-53-2
- Molecular formula:
- C14H19NO
- IUPAC Name:
- ethoxyquin
- Details on test material:
- Chemical name
IUPAC: 6-ethoxy-2,2,4-trimethyl-1,2-dihydroquinoline
CAS: 6-ethoxy-1,2-dihydro-2,2,4-trimethylquinoline
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hazleton Research Products, Inc. Denver PA USA
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- 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:
- 4h
- Observation period:
- ≥ 7d
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure:
- % coverage:
- Type of wrap if used: semi-occlusive dressings / bandages
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 4h
OBSERVATION TIME POINTS
Application sites were evaluated in accordance with the method of Draize at approximately 30 - 60 minutes and 24, 48 and 72 hours after patch removal and daily thereafter through Day 7 since erythema still persisted in few animals at 72 hours.
SCORING SYSTEM:
- Method of calculation: Draize / according to OECD 404
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.333
- Max. score:
- 1
- Reversibility:
- fully reversible within: 4 days or earlier
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- The test material induced very slight erythema on five animals. Desquamation was noted on two sites. There were no edema or other dermal findings. With the exception of desquamation on two sites, all dermal irritation completely subsided by Day 4 or earlier.
- Other effects:
- There were no deaths during the study. There were no remarkable body weight changes during the study period.
Any other information on results incl. tables
Table Individual and mean skin irritation scores according to Draize
|
Erythema |
Edema |
||||||||||
Animal No. |
708 |
712 |
715 |
725 |
735 |
742 |
708 |
712 |
715 |
725 |
735 |
742 |
After 1h |
1 |
1 |
0 |
0 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
After 24h |
0 |
1 |
1 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
After 48h |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
After 72h |
0 |
0 |
1 d |
0 |
1 d |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Mean score 24-72h |
0.333 |
0.0 |
||||||||||
Additional criteria specified in Directive 93/21/EEC Point 3.2.6.1 fulfilled: No |
d = Desquamation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- As information was provided via a peer-reviewed assessment report, it can be considered as sufficiently reliable to assess the skin irritation potential of ethoxyquin in rabbits. Based on the observations after 24, 48 and 72 hours, the overall mean scores for erythema, eschar formation and edema were 0.33, 0.0 and 0.0, respectively. One hour after patch removal, erythema (but no edema) was seen in four out of six rabbits. If this observation time point is included, primary irritation index would be 0.4. Perhaps because of this calculation, classification by the notifier was “slightly irritating”. However, in fact, no classification according to Dir 67/548/EEC is required.
According to Regulation 1272/2008, classification as Skin irritation category 2 is triggered if:
(1) Mean value of ≥ 2,3 - ≤ 4,0 for erythema/ eschar or for oedema in at least 2 of 3 tested animals from gradings at 24, 48 and 72 hours after patch removal or, if reactions are delayed, from grades on 3 consecutive days after the onset of skin reactions; or
(2) Inflammation that persists to the end of the observation period normally 14 days in at least 2 animals, particularly taking into account alopecia (limited area), hyperkeratosis, hyperplasia, and scaling; or
(3) In some cases where there is pronounced variability of response among animals, with very definite positive effects related to chemical exposure in a single animal but less than the criteria above.
Based on the available results, this is not the case, so classification as skin irritant is also not triggered according to Regulation 1272/2008. - Executive summary:
In a primary dermal irritation study (US EPA FIFRA § 81-5, equivalent to OECD 404), six New Zealand White rabbits were dermally exposed to 0.5 ml of neat ethoxyquin for 4 hours. Animals then were observed for ≥ 7 days. Irritation was scored by the method of Draize.
There were no deaths during the study. The test material induced very slight erythema on five animals. Desquamation was noted on two sites. There were no edema or other dermal findings. With the exception of desquamation on two sites, all dermal irritation completely subsided by Day 4 or earlier. There were no remarkable body weight changes during the study period.
In this study, ethoxyquin is not a dermal irritant, no classification is triggered.
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