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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
Endpoint summary
Administrative data
Description of key information
Skin / eye irritation / corrosion in vitro: Data waiving, in vivo studies are available.
Skin irritation in vivo: not irritating, rabbits, 0.5ml undiluted, semiocclusive (OECD 404, GLP)
Eye irritation in vivo: not irritating, rabbits, 0.1ml undiluted, semiocclusive ( US EPA FIFRA Guideline § 81-4, GLP)
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- 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)
- 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
- 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 - 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 - 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.
- 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.
Reference
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
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye 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)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-4 (Acute Eye Irritation)
- Version / remarks:
- US EPA FIFRA Guideline § 81-4
- Deviations:
- yes
- Remarks:
- Purity of the test compound was not determined by the laboratory prior to conduct of the test.
- GLP compliance:
- yes
- Remarks:
- self-certified to US EPA regulations at 40 CFR Parts 160, 792
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hazleton Research Products, Inc. Denver PA USA - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Left eyes were manipulated in a similar manner as the right eyes and served as contralateral controls.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- The eyes of all rabbits remained unwashed.
- Observation period (in vivo):
- 96 h
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): The eyes of all rabbits remained unwashed.
SCORING SYSTEM: The eyes were examined for ocular reactions in accordance with the method of Draize at approximately 1, 24, 48 and 72 hours, and, since conjunctival redness was still noted after 72 hours, on Day 4.
TOOL USED TO ASSESS SCORE: fluorescein; Sodium fluorescein was used to aid in revealing corneal damage at 72 hours. - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- conjunctive - redness
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.444
- Max. score:
- 2
- Reversibility:
- fully reversible within: 96h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.167
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72h
- Irritant / corrosive response data:
- The left (control) eyes of all rabbits were free of evidence of ocular irritation and other findings for the duration of the study. The right (test) eye for one rabbit exhibited a positive conjunctival reaction and all animals had minor conjunctival irritation. There was no evidence of any damage to the iris or the cornea. All ocular irritation was reversible and completely subsided by Day 4 or earlier. There were no remarkable changes or differences observed in body weights during the study period. The maximum average score for ethoxyquin was 3.7 and was observed at one hour postinstillation.
- Other effects:
- There were no deaths during the study.
- 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 eye irritation potential of ethoxyquin in rabbits.
The “Primary Eye Irritation Score” for each observation time is calculated as the sum of all individual irritation scores at that time divided by the number of animals in the group. Taking these values for the 24-, 48- and 72-hour observations into account, overall mean scores for corneal opacity, iris lesions, redness of the conjunctivae and edema of the conjunctivae (chemosis) will result. In this study, only conjunctival redness and chemosis were observed and for these findings, low mean scores of 0.44 and 0.17 were calculated.
If the 1-hour values for conjunctiva redness and conjunctiva chemosis are included in that calculation, mean scores would augment to 0.624 and 0.289, respectively.
Based on these results and in accordance with Annex VI of Commission Directive 2001/59/EC, ethoxyquin shall not be classified as an eye irritant.
According to Regulation 1272/2008, a substance must be classified as Irritating to eyes (Category 2), if, when applied to the eye of an animal, a substance produces:
— at least in 2 of 3 tested animals, a positive response of:
— corneal opacity ≥ 1 and/or
— iritis ≥ 1, and/or
— conjunctival redness ≥ 2 and/or
— conjunctival oedema (chemosis) ≥ 2
— calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material, and which fully reverses within an observation period of 21 days.
In the present study, ethoxyquin was tested on six rabbits. In none of the tested animals the above-mentioned scores met or exceeded the scores triggering classification, so also according to Regulation 1272/2008, ethoxyquin does not need to be classified as eye irritant. - Executive summary:
In a primary eye irritation study [US EPA FIFRA Guideline § 81-4], 0.1 ml of undiluted ethoxyquin was instilled into the conjunctival sac of the right eye of six New Zealand white rabbits. Eyes were not washed. Animals then were observed for ≥ 4 days. Irritation was scored by the method of Draize.
There were no deaths during the study. The left (control) eyes of all rabbits were free of evidence of ocular irritation. The right (test) eye for one rabbit exhibited a positive conjunctival reaction and all animals had minor conjunctival irritation. There was no evidence of any damage to the iris or the cornea. All ocular irritation was reversible and completely subsided by Day 4 or earlier. There were no remarkable changes or differences observed in body weights during the study period. The maximum average score for ethoxyquin was 3.7 and was observed at one hour postinstillation.
In this study, ethoxyquin is not an eye irritant and does not need to be classified.
Reference
Table Eye irritation scores according to the Draize scheme - unwashed eyes
|
Cornea |
Iris |
Conjunctiva - Redness |
Conjunctiva - Chemosis |
||||||||||||||||||||
Time / rabbit No. |
1 |
2 |
3 |
4 |
5 |
6 |
1 |
2 |
3 |
4 |
5 |
6 |
1 |
2 |
3 |
4 |
5 |
6 |
1 |
2 |
3 |
4 |
5 |
6 |
1 h |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
1 |
2 |
1 |
1 |
1 |
0 |
1 |
1 |
0 |
1 |
24 h |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
1 |
1 |
0 |
1 |
0 |
0 |
1 |
1 |
0 |
0 |
48 h |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
72h |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Mean scores 24-72 h |
0.0 |
0.0 |
0.444 |
0.167 |
Additional criteria in Directive 93/21/EEC Point 3.2.6.2 fulfilled: No
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
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 observations made in the study according to US EPA FIFRA § 81-5 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 (EC) No. 1272/2008, a substance must be classified as eye irritant category 2, if, when applied to the eye of an animal, a substance produces:
— at least in 2 of 3 tested animals, a positive response of:
— corneal opacity≥1 and/or
— iritis≥1, and/or
— conjunctival redness≥2 and/or
— conjunctival oedema (chemosis)≥2
— calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material, and which fully reverses within an observation period of 21 days
In the study according to US EPA FIFRA Guideline § 81-4 in none of the tested animals the above-mentioned scores met or exceeded the scores triggering classification, so also according to Regulation 1272/2008, ethoxyquin does not need to be classified as eye irritant.
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