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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 696-317-2 | CAS number: 174489-76-0
- 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)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
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)
- Deviations:
- yes
- Remarks:
- The relative humidity was observed below 40 % in the test laboratory
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- prop-2-en-1-yl 2-(2-chloro-5-nitrobenzoyloxy)-2-methylpropanoate
- EC Number:
- 696-317-2
- Cas Number:
- 174489-76-0
- Molecular formula:
- C14H14ClNO6
- IUPAC Name:
- prop-2-en-1-yl 2-(2-chloro-5-nitrobenzoyloxy)-2-methylpropanoate
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Himalayan Spotted (GOH)
- Sex:
- male/female
- Details on test animals and environmental conditions:
TEST ANIMALS
- Source: RCC Ltd, Biotechnology & Animal Breeding Division, Wölferstrasse 4, CH-4414, Füllinsdorf / Switzerland
- Age at study initiation: 4 - 6 weeks
- Weight at study initiation: Pretest groups - males 362 - 368 g, females 358 g. Control and test group - males 317 - 406 g, females 294 - 336 g.
- Housing: Individual
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 ° C
- Humidity (%): 28 - 55 %
- Air changes (per hr): 10 - 15/hour
- Photoperiod (hrs dark / hrs light): 12/12/hours
The animal were distributed as follows:
Number of animals per group Animal numbers per group
1 Control Group 10 422 - 431
2 Test Group 20 432 - 451
3 Intradermal Pre-test 1 452
4 Epidermal Pre-test 2 453 - 454
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- 1 % + 1 % Tween 80 in distilled water
- Concentration / amount:
- Intradermal Induction: 5 %
Epidermal Induction: 75 %
Epidermal Challenge: 75 %
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- 1 % + 1 % Tween 80 in distilled water
- Concentration / amount:
- Intradermal Induction: 5 %
Epidermal Induction: 75 %
Epidermal Challenge: 75 %
- No. of animals per dose:
Number of animals per group Animal numbers per group
1 Control Group 10 422 - 431
2 Test Group 20 432 - 451
3 Intradermal Pre-test 1 452
4 Epidermal Pre-test 2 453 - 454- Details on study design:
- RANGE FINDING TESTS:
Pre-test:
The pre-tests were performed with the test material before and during the acclimatization period of the control and test group.
Intradermal Injections:
The three concentrations for the intradermal injection pre-tests were determined during formulation trials performed prior to the acclimatization. The concentration of 5 % was considered to be the highest technically applicable concentration which could be injected into the intra-cellular space in spite of the high viscosity of the application dilution and the obstacle caused by the tissues.
Four intradermal injections (0.1 ml/site) of a 1:1 (v/v) mixture of FVA/physiological saline were made into the shaved neck of one guinea pig. One week later intradermal injections (0.1 ml/site) were made into the clipped flank of the same guinea pig. At concentrations of 5, 3 and 1 % of the test item in the vehicle.
Dermal reactions were assessed 24 hours later using the Magnusson and Klingman scoring method.
Epidermal injections:
Prior to testing, it was determined that a 75 % concentration of the test material in the vehicle was the highest which could be applied to the skin to ensure optimal skin contact during the treatment period and to avoid mechanical irritation caused by the test item.
Four intradermal injections 0.1 ml/site of a 1:1 (v/v) mixture of FCA/physiological saline were made to the shaved neck of two guinea pigs. One week later both flanks of each of the guinea pigs were clipped and shaved just prior to the application.
Thereafter 4 patches of filter paper (3 x 3 cm) were saturated with the test item at 75, 50, 25 and 15 % in the vehicle and applied to the clipped and shaved flanks. The amount of test item preparation applied was approximately 0.2 g for the test item at 75 % and 50 % and a volume of approximately 0.2 ml was applied for the remaining test item concentrations. The patches were covered by a strip of aluminium foil and firmly secured by elastic plaster wrapped around the trunk and covered with impervious adhesive tape. This procedure ensured the intensive contact of the test item.
The dressings were removed after an exposure of 24 hours.
The reaction sites were assessed 24 and 48 hours after removal of the bandage for erythema and oedema according to the method of Magnusson and Klingman.
Main Study
Intradermal injections - Test Day 1:
3 x 0.1 ml injections
Test group
1) 1:1 (v/v) mixture of FCA and physiological saline.
2) The test item at 5 % in the vehicle
3) The test item in a 1:1 (v/v) mixture of FCA and physiological saline.
Control group
1) 1:1 (v/v) mixture of FCA/physiological saline.
2) The vehicle alone.
3) 1:1 (w/w) mixture of the vehicle and a 1:1 (v/v) mixture of FCA and physiological saline.
Epidermal Applications – Day 8:
Test group
Approximately 0.3 g of the test item (75 % in vehicle) was saturated on a 2 x 4 cm patch of filter paper.
Control group
0.3 ml of the vehicle only.
Challenge – Day 22
Test and Control group were treated in the same way.
Left and right flank of each animal clipped and shaved.
2 patches of 3 x 3 cm filter paper were saturated with 0.2 g of the test item at the highest non-irritating concentration of 75 % and 0.2 ml of vehicle
only. These patches were applied to and applied to the left flank (test item) and the right flank (vehicle), using the same method as for the epidermal application. - Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- other: Epdermal Induction
- Hours after challenge:
- 24
- Group:
- other: Control
- No. with + reactions:
- 6
- Total no. in group:
- 10
- Clinical observations:
- Discrete/patchy erythema
- Remarks on result:
- other: Reading: other: Epdermal Induction. . Hours after challenge: 24.0. Group: other: Control. No with. + reactions: 6.0. Total no. in groups: 10.0. Clinical observations: Discrete/patchy erythema.
- Reading:
- other: Epidermal Induction
- Hours after challenge:
- 48
- Group:
- other: Control
- No. with + reactions:
- 6
- Total no. in group:
- 10
- Clinical observations:
- Discrete/patchy erythema
- Remarks on result:
- other: Reading: other: Epidermal Induction. . Hours after challenge: 48.0. Group: other: Control. No with. + reactions: 6.0. Total no. in groups: 10.0. Clinical observations: Discrete/patchy erythema.
- Reading:
- other: Epidermal Induction
- Hours after challenge:
- 24
- Group:
- test chemical
- No. with + reactions:
- 19
- Total no. in group:
- 20
- Clinical observations:
- Discrete/patchy to moderate/confluent erythema
- Remarks on result:
- other: Reading: other: Epidermal Induction. . Hours after challenge: 24.0. Group: test group. No with. + reactions: 19.0. Total no. in groups: 20.0. Clinical observations: Discrete/patchy to moderate/confluent erythema .
- Reading:
- other: Epidermal Induction
- Hours after challenge:
- 48
- Group:
- test chemical
- No. with + reactions:
- 19
- Total no. in group:
- 20
- Clinical observations:
- Discrete/patchy to moderate/confluent erythema
- Remarks on result:
- other: Reading: other: Epidermal Induction. . Hours after challenge: 48.0. Group: test group. No with. + reactions: 19.0. Total no. in groups: 20.0. Clinical observations: Discrete/patchy to moderate/confluent erythema.
- Reading:
- other: Challenge
- Hours after challenge:
- 24
- Group:
- other: Control
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No skin reaction observed
- Remarks on result:
- other: Reading: other: Challenge. . Hours after challenge: 24.0. Group: other: Control. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No skin reaction observed.
- Reading:
- other: Challenge
- Hours after challenge:
- 48
- Group:
- other: Control
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No skin reaction observed
- Remarks on result:
- other: Reading: other: Challenge. . Hours after challenge: 48.0. Group: other: Control. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No skin reaction observed.
- Reading:
- other: Challenge
- Hours after challenge:
- 24
- Group:
- test chemical
- No. with + reactions:
- 15
- Total no. in group:
- 20
- Clinical observations:
- Discrete/patchy to moderate/conflent erythema
- Remarks on result:
- other: Reading: other: Challenge. . Hours after challenge: 24.0. Group: test group. No with. + reactions: 15.0. Total no. in groups: 20.0. Clinical observations: Discrete/patchy to moderate/conflent erythema.
- Reading:
- other: Challenge
- Hours after challenge:
- 48
- Group:
- test chemical
- No. with + reactions:
- 16
- Total no. in group:
- 20
- Clinical observations:
- Dicrete/patchy to moderate/confluent erythema
- Remarks on result:
- other: Reading: other: Challenge. . Hours after challenge: 48.0. Group: test group. No with. + reactions: 16.0. Total no. in groups: 20.0. Clinical observations: Dicrete/patchy to moderate/confluent erythema.
Any other information on results incl. tables
There were no deaths during the course of the study, hence no necropsies were performed.
No signs of systemic toxic were observed in the animals.
The body weight of the animals was within range commonly recorded for animals of this strain and age.
Applicant's summary and conclusion
- Interpretation of results:
- other: May cause sensitization by skin contact
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The 80 % incidence of skin reactions to the test material is above the threshold (30 % for adjuvant tests) set in Commission Directive 93/21/EEC. Therefore, CA 2218 A (Intermediate of CGA 276854) is required to be classified as ‘May cause sensitization by skin contact’.
- Executive summary:
In order to assess the cutaneous allergenic potential of CA 2218 A (Intermediate of CGA 276854), Maximisation-Test was performed in 5 male and 5 female control and 10 male and 10 female test albino guinea pigs, in accordance with OECD Guideline No. 406 and the Directive 96/54/EEC, B.6.
The intradermal induction of the test group animals was performed with 5 % concentrations of the test item in the vehicle (1 % CMC + 1 % Tween 80 in distilled water) and in Freund’s Complete Adjuvant (FCA) (as 1:1 FCA in physiological saline). Control group animals were injected with the vehicle control alone and FCA/physiological saline alone. On study day 7, the test areas of all animals were pre-treated with 10 % sodium-lauryl-sulfate. Beginning on study day 8, the epidermal induction was conducted for 48 hours with a 75 % concentration of the test item in the vehicle (test group animals) or vehicle alone (control group animals). Two weeks after epidermal induction, the control and test animals were challenged by epidermal application of the test item at 75 % in the vehicle and the vehicle alone. Cutaneous reactions were evaluated 24 and 48 hours after removal of the dressing.
After 24 hours
Positive / Total
% positive of total
After 48 hours
Positive / Total
% positive of total
CONTROL GROUP
CA 2218 A, 75 % in vehicle (left flank)
Vehicle only
0 / 10
0
0 / 10
0
0 / 10
0
0 / 10
0
TEST GROUP
CA 2218 A, 75 % in vehicle (left flank)
Vehicle only
15 / 20
75
0 / 20
0
16 / 20
80
0 / 20
0
Fifteen (at the 48 hour reading) and 16 (at the 48 hour reading) out of the 20 test animals showed discrete/patchy to moderate/confluent erythema after challenge treatment with CA 2218 A (Intermediate of CGA 276854) at 75 % (w/w) in the vehicle. No skin effect was observed in the control group.
No toxic symptoms were evident in the guinea pigs of the control or test group.
No deaths occurred.
The 80 % incidence of skin reactions to the test material is above the threshold (30 % for adjuvant tests) set in Commission Directive 93/21/EEC. Therefore, CA 2218 A (Intermediate of CGA 276854) is required to be classified as ‘May cause sensitization by skin contact’.
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.