Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 443-010-4 | CAS number: 53641-10-4
- 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)
- Remarks:
- maximization test in guinea pig
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1999-12-06 to 2000-03-09
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- adopted July 17, 1992
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- An appropriate guinea pig maximisation test is available which would not justify conducting an additional LLNA due to animal welfare.
Test material
- Reference substance name:
- -
- EC Number:
- 443-010-4
- EC Name:
- -
- Cas Number:
- 53641-10-4
- Molecular formula:
- C14H15ClN2O4
- IUPAC Name:
- N-[3-chloro-4-(3-oxobutanamido)phenyl]-3-oxobutanamide
- Test material form:
- solid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: gpg, Pirbright-White HsdPoc:DH
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: HARLAN WINKELMANN, Gartenstraße 27, 33178 Borchen, SPF breeding colony
- Weight at study initiation: males: 350 g - 410 g
- Housing: Groups of five animals in fully air-conditioned rooms in macrolon cages (type 4) on soft wood granulate
- Diet (e.g. ad libitum): ssniff Ms-H (V 2233), ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least one week
- Animal identification: fur marking with KMnO4 and cage numbering
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C
- Humidity (%): 50 +/- 20%
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- water
- Remarks:
- deionized
- Concentration / amount:
- intradermal: 5 % in deionized water
- Day(s)/duration:
- day 1: induction
days 2-7: The administration area was examined for local tolerance. Systemic toxic
effects were recorded, when apparent. - Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Remarks:
- deionized
- Concentration / amount:
- 25 % in deionized water
- Day(s)/duration:
- day 8: induction
The administration area was then kept under an occlusive
bandage covered with an impermeable film and an elastic bandage for
48 hours - Adequacy of induction:
- non-irritant substance, but skin pre-treated with 10% SDS
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Remarks:
- deionized
- Concentration / amount:
- dermal: 25 % in deionized water
- Day(s)/duration:
- The administration area was then kept for
24 hours under an occlusive bandage covered with an impermeable film
and an elastic bandage. - Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Number of animals in test item group: 10
Number of animals in negative control group: 5 - Details on study design:
- Test procedure
The following preparations were used for the intradermal injections:
Control group:
Injection 1: a 1:1 mixture (v/v) FCA (Freund’s Complete Adjuvant)/ deionized water
Injection 2: deionized water
Injection 3: a 1:1 mixture (v/v) FCA (Freund’s Complete Adjuvant)/ deionized water (=vehicle)
Treatment group:
Injection 1: a 1:1 mixture (v/v) FCA/ deionized water
Injection 2: 5% of test chemical in deionized water
Injection 3: 5% of the test chemical in a 50% FCA solution
Determination of the primary non-irritant concentration:
Prior to the determination of the primary non-irritation concentration in a dermal occlusive test the animals received 4 intradermal injections of 50% FCA emulsion (4 x 0.1ml) into the dorsal area, since FCA may lower the threshold of primary irritation. Thereafter, each of the following test concentrations were administered to the flanks of two guinea pigs:
25% test item concentration in deionized water
5.0% test item concentration in deionized water
1.0% test item concentration in deionized water
The hair of the flanks of the animals was removed mechanically. 0.5 ml of the test substance preparation was administered to a 2x2 cm cellulose patch, which was fixed to the flank and covered occlusively for 24 hours with a bandage and film. 24 hours after removal of the patches, the treated skin areas were examined for erythema and edema.
Determination of the tolerance of the intradermal injections
To determine the tolerance of intradermal injections, each of the following preparations were administered twice by intradermal injection to 2 guinea pigs:
2 x 0.1 ml 5.0 % deionized water
2 x 0.1 ml 1.0 % deionized water
2 x 0.1 ml 0.2 % deionized water
The injection sites were all within a dorsal area measuring 2 x 4 cm in the vicinity of the shoulders. 24, 48, 72 and 96 hours after administration the injection sites were examined for local tolerance.
Main test for the sensitizing properties
Day 0: The body weight of the animals was determined. The guinea pigs were shaved mechanically over a dorsal area of 4 x 6 cm in the vicinity of the shoulders.
Day 1: Intradermal induction treatment:
Two intradermal injections per animal of the following preparations were applied. The injection sites were all within the dorsal area and left uncovered.
Treatment group:
Site 1: 2 x 0.1 ml of a 1:1 mixture (v/v) FCA/ deionized water
Site 2: 2 x 0.1 ml of 5% of test chemical in deionized water
Site 3: 2 x 0.1 ml of 5% of the test chemical in a 50% FCA solution
Control group:
Site 1: 2 x 0.1 ml of a 1:1 mixture (v/v) FCA/ deionized water
Site 2: 2 x 0.1 ml of deionized water
Site 3: 2 x 0.1 ml of a 1:1 mixture (v/v) FCA / deionized water (=vehicle)
Day 2-7: The administered area was examined for local tolerance. Systemic toxic effects were recorded, when apparent.
Day 8: Dermal induction treatment:
An amount of 0.5 ml of the test substance (25% test substance in deionized water = treatment group) or vehicle (deionized water) for the control group was administered to a 2 x 4 cm cellulose patch. This patch covered the area where the intradermal injection had been placed. The administration area was then kept under an occlusive bandage covered with an impermeable film and an elastic bandage for 48 hours.
Day 10: Occlusive bandage was removed, irritant effects were recorded, when apparent.
Day 11-21: Test animals were kept under observation.
Day 22: Dermal challenge treatment:
One area of 5 x 5cm on the left flank was shaved mechanically. An amount of 0.5 ml of the test substance 25% test substance in deionized water (treatment group and control group) was administered to a 2 x 2 cm cellulose patch. The administration area was then kept under an occlusive bandage covered with an impermeable film and an elastic bandage for 48 hours.
Day 23: Occlusive bandage was removed. Any remnants of the test substance were washed off with warm water.
Day 24: Examination of the skin approx. 24 hours after the removal of the patches.
Day 25: Examination of the skin approx.. 48 hours after the removal of the patches. Body weight of the test animals was determined. - Positive control substance(s):
- yes
- Remarks:
- positive control assay with alpha-hexyl cinnamic aldehyde: Testing for the sensitizing properties of alpha-hexyl cinnamic aldehyde was performed in female guinea pigs according to the method of BUEHLER.
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 25% alpha-hexyl cinnamic aldehyde
- No. with + reactions:
- 6
- Total no. in group:
- 20
- Remarks on result:
- other: Testing for the sensitizing properties of a/pha-hexyl cinnamic aldehyde was performed in female guinea pigs according to the method of BUEHLER.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 25% alpha-hexyl cinnamic aldehyde
- No. with + reactions:
- 5
- Total no. in group:
- 20
- Remarks on result:
- other: Testing for the sensitizing properties of a/pha-hexyl cinnamic aldehyde was performed in female guinea pigs according to the method of BUEHLER.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- polyethylene glycol 400
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Testing for the sensitizing properties of a/pha-hexyl cinnamic aldehyde was performed in female guinea pigs according to the method of BUEHLER.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- polyethylene glycol 400
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Testing for the sensitizing properties of a/pha-hexyl cinnamic aldehyde was performed in female guinea pigs according to the method of BUEHLER.
Any other information on results incl. tables
Main test for the sensitizing properties:
Body weight gains and clinical signs
The body weight gains of the animals were not impaired.
The treated animals showed no clinical signs of intoxication throughout the study.
Maximum concentration not causing irritating effects in test: 25 %
Signs of irritation during induction:
The intradermal injections (with and without test substance)
caused severe erythema and edema as well as indurations and
encrustations. The intradermal injection with test substance
in vehicel caused slight erythema and edema. The intradermal
injection of the vehicel alone exhibited no signs of
irritation. The dermal induced application with FCA caused
severe erythema and edema as well as indurations,
encrustations and necrosis. The test substance in vehicel
and the vehicel alone exhibited no signs of irritation.
Evidence of sensitisation of each challenge concentration:
treatment group: 0/10
control group: 0/5
Dermal induction treatment:
After the removal of the patches at day 10, severe erythema and edema, indurated,
and encrusted skin as well as necrosis were observed at the sites previously treated
with Freund's Adjuvant. The administration sites treated with the test substance or the
vehicle alone showed no signs of irritation.
Dermal challenge treatment:
No skin reactions were observed in the control and the treatment group 24 and 48
hours after removal of the occlusive bandage.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Based on the results of this study the test item showed no evidence for sensitizing properties.
- Conclusions:
- Under the conditions of the present study, none of the animals of the treatment group showed a positive skin response after the challenge procedure. Therefore, based on the results of this study the test item showed no evidence for sensitizing properties.
- Executive summary:
Maximum concentration not causing irritating effects in test: 25 %
Signs of irritation during induction:
The intradermal injections (with and without test substance)
caused severe erythema and edema as well as indurations and
encrustations. The intradermal injection with test substance
in vehicel caused slight erythema and edema. The intradermal
injection of the vehicel alone exhibited no signs of
irritation. The dermal induced application with FCA caused
severe erythema and edema as well as indurations,
encrustations and necrosis. The test substance in vehicel
and the vehicel alone exhibited no signs of irritation.
Evidence of sensitisation of each challenge concentration:
treatment group: 0/10
control group: 0/5
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.