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EC number: 404-740-9 | CAS number: 115895-09-5
- 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 irritation (OECD 404): not irritating
Eye irritation (OECD 405): not irritating
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
- Study period:
- from October 3rd, 1988 to October 7th, 1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study performed according to the Test Guideline B.4 of the EEC Directive 84/449/EEC and OECD guideline N°404
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- test substance was applied under occlusive conditions without justification
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- test substance was applied under occlusive conditions without justification
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Healthy male, young adult, New Zealand White albino rabbits, obtained from
ENKI—Konijnenfarm, Someren, the Netherlands, were used as experimental
animals. Age at study initiation: young adult.
The body weight range was 2571—3108 g. The animals were
identified by earmarking, and subsequently housed individually in
suspended, galvanized cages, fitted with a wire—mesh floor and front.
Acclimation period : 6 days.
The cages were placed in a room, controlled for light (12 hours light/12 hours
dark cycle), temperature (18 ± 3°C), ventilation (c. 10 air changes/hour),
and relative humidity (at least 40%) throughout the test period.
A standard laboratory rabbit diet and tap water were provided ad libitum. - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Remarks:
- 1:1 ratio of test substance and water
- Controls:
- other: not required, the untreated site of the same rabbit served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1.0 g
- Concentration (if solution): 50%
VEHICLE
- Amount(s) applied (volume or weight with unit): 1.0 g
- Concentration (if solution): 50% - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
Reading time points: 1, 24, 48 and 72 h - Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: a shaved, 2.5 cm diameter area on the back or flank of the rabbit
- Type of wrap if used: a plastic cup with the test solution (0.5 g test substance, 0.5 g water) was placed on an area of intact skin and fixed to the application site by means of adhesive tape (Leukopor, BDF). The entire trunk of the rabbit was wrapped with self-adhesive gauze (Fixomull, art. No. 2112, BDF, Germany) to hold the cup in place.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the substance was removed from the skin area after exposure ended
- Time after start of exposure: 4 h
SCORING SYSTEM: Draize scoring system - Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- There were no skin irritation reactions at any time point in any animal.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- On the basis of the resuits obtained it is conciuded that, under the
conditions of this study and according to the EEC—standards (as published
in the Official Journal of the European Coxumunities, L 257, Volume 26,
16 September 1983), “AF—366” is not irritating or corrosive to skin.
Reference
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
- Study period:
- 1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study performed according to the Test Guideline B.5 of the EEC Directive 84/449/EEC and OECD guideline N°405
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Healthy male, young adult, New Zealand White albino rabbits, obtained from
ENKI—Konijnenfarm, Someren, the Netherlands, were used as the experimental
animals. The body weight range was 2670—3055 g. The animals ware
identified by earmarking, and subsequently housed individually in
suspended, galvanized cages, fitted with a wire—mesh floor and front. The
cages ware placed in a room, controlled for light (12 hours light42 hours
dark cycle), temperature (18 ± 3°C), ventilation (c. 10 air changes/hour),
and relative humidity (at least 40%) throughout the test period.
A standard laboratory rabbit diet and tap water ware provided ad libitum. - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye served as the control
- Amount / concentration applied:
- - Amount(s) applied (volume or weight with unit): 0.1ml (0.071g)
- Duration of treatment / exposure:
- at least 1 second
Single application without washing - Observation period (in vivo):
- 72 hours
Reading time points: 1, 24, 48 and 72 h - Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): the treated eye was not washed after application - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: mean over 24, 48 and 72h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48 and 72h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48 and 72h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: mean over 24, 48 and 72h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48 and 72h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48 and 72h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72h
- Irritant / corrosive response data:
- Remains of the test substance were observed in the treated eye of 3/3 rabbits 1 hour after instillation, but disappeared within 24 hours. At the 1-hour reading time point, 3/3 rabbits had slight to moderate conjunctivae (redness) and slight chemosis. 24 and 48 hours after instillation, 2/3 rabbits still had slight conjunctivae and chemosis. All the eye irritation effects had cleared within 72 hours.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- On the basis of the resuits obtained it is concluded that, under the
conditions of this study and according to the EEC—standards (as published
in the Official Journal of the European Communities, L 257, Volume 26, 16
September 1983), the substance “AF—366” is not irritating or corrosive to
eyes.
Reference
Table 1. Results of eye irritation study
Rabbit #
|
Time [h]
|
conjunctivae
|
iris
|
cornea
|
|
redness |
swelling |
||||
1
|
1 |
1 |
1 |
0 |
0 |
24 |
0 |
0 |
0 |
0 |
|
48 |
0 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
|
average |
0.0 |
0.0 |
0.0 |
0.0 |
|
2
|
1 |
1 |
1 |
0 |
0 |
24 |
1 |
1 |
0 |
0 |
|
48 |
1 |
1 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
|
average |
0.67 |
0.67 |
0.0 |
0.0 |
|
3
|
1 |
2 |
1 |
0 |
0 |
24 |
1 |
1 |
0 |
0 |
|
48 |
1 |
1 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
|
average |
0.67 |
0.67 |
0.0 |
0.0 |
|
Time [h] |
conjunctivae
|
iris |
cornea |
|
|
redness |
swelling |
|
|
|
average score |
1 |
1.33 |
1.00 |
0.00 |
0.00 |
24 |
0.67 |
0.67 |
0.00 |
0.00 |
|
48 |
0.67 |
0.67 |
0.00 |
0.00 |
|
72 |
0.00 |
0.00 |
0.00 |
0.00 |
|
24+48+72 |
0.45 |
0.45 |
0.00 |
0.00 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The skin irritation potential of ethyl 3,5-dichloro-4- hexadecyloxycarbonyloxybenzoate (AF-366) was assessed in a study performed according to OECD guideline 404 (Prinsen, 1988a). 0.5 g of the test substance was moistened with 0.5 g water and applied to the shaved skin of rabbits under occlusive conditions for 4 hours. No skin irritation effects (erythema and edema) were observed in any of the animals at the reference time points 1, 24, 48 and 72 h. There was no mortality and no signs of systemic toxicity were observed.
The eye irritation potential of ethyl 3,5 -dichloro-4 -hexadecyloxycarbonyloxybenzoate (AF-366) was evaluated in a study performed according to OECD guideline 405 (Prinsen, 1988b). 0.1 mL (approximately 0.071 g) of the test substance was instilled into one eye of 3 male rabbits, without washing the eye after the 24 -hour exposure period. The irritating effects were assessed 1, 24, 48 and 72 hours after the treatment ended. 3/3 animals had slight to moderate redness (conjunctivae) and slight chemosis at the 1-hour reading time point. For all the animals, the mean values of the 24, 48 and 72 -hour reading time points were 0 -0.67 for both redness and chemosis. The irritation effects were completely reversible within 72 hours.
Justification for classification or non-classification
The available data on skin irritation and eye irritation of the test substance do not meet the criteria for classification according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.
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