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EC number: 202-269-1 | CAS number: 93-70-9
- 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 (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2004-08-26 to 2004-09-07
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study documented and performed according to GLP standards and in compliance with OECD Guideline 429: Skin sensitization: Local Lymph Node Assay
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable.
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 2'-chloroacetoacetanilide
- EC Number:
- 202-269-1
- EC Name:
- 2'-chloroacetoacetanilide
- Cas Number:
- 93-70-9
- Molecular formula:
- C10H10ClNO2
- IUPAC Name:
- 2'-chloroacetoacetanilide
- Details on test material:
- Identity: Acetoacet-o-chloroanilide
Aggregate state at RT: Solid
Color: White
Storage: At RT, dry. dark
Expiry date: July 25, 2006
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- Strain: CBA/CaOlaHsd
Source: Harlan Netherlands
Number of animals for pre-test: 2 females
Number of animals for main study: 16 females
Number of animals per group: 4 females (nulliparous and non-pregnant)
Age: 8-12 weeks (beginning of acclimatization)
Identification: Single caging.
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- 5, 10, 25 % (in DMF)
- No. of animals per dose:
- 4 females
- Details on study design:
- For determination of the highest non-irritant and technically applicable test item concentration, a non-GLP pretest was performed on two mice
with concentrations of 2.5, 5, 10, and 25 % (w/v). The top dose of the test item is the highest technically achievable concentration whilst avoiding
systemic toxicity and excessive local irritation. Four female mice were treated with different concentrations of the test item and vehicle alone by
topical application at the dorsum of each ear lobe (left and right) on three consecutive days. Five days after the first topical application, the mice were intravenously injected into a tail vein with radio-labelled thymidine (3H-methyl thymidine).
Five hours after intravenous injection, the mice were sacrificed and the draining auricular lymph nodes excised and pooled per group.
Single cell suspensions of lymph node cells were prepared from pooled lymph nodes which were subsequently washed and incubated with
trichloroacetic acid overnight. The proliferative capacity of pooled lymph node cells was determined by the incorporation of 3H-methyl
thymidine measured in a ß-scintillation counter. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- The proliferative response of lymph node cells is expressed as the number of radioactive disintegrations per
minute per lymph node and as the ratio of 3HTdR incorporated into lymph node cells of test lymph nodes relative to that recorded for
control lymph nodes (stimulation index). Before DPM/node values were determined, mean scintillation-background DPM was subtracted from test andcontrol raw data.
The mean values and standard deviations were calculated in the body weight tables.
A statistical analysis was conducted for assessment of the dose-response relationship, and the EC3 value was calculated according to the equation
EC3 = (a-c) [(3-d)/(b-d)] + c
where EC3 is the estimated concentration of the test item required to produce a 3-fold increase in draining lymph node cell proliferative activity;
(a, b) and (c, d) are respectively the co-ordinates of the two pair of data lying immediately above and below the S.I. value of
3 on the local lymph node assay dose response plot.
Results and discussion
- Positive control results:
- Positive control substance: α-Hexylcinnamaldehyde
Vehicle: Acetone/olive oil
Test item concentration %
(w/v) S.I.
Group 2 5 (a) 2.0 (b)
Group 3 10 (c) 3.0 (d)
EC3 = (a-c) [(3-d)/(b-d)] + c = 9.9 % (w/v)
EC3 = Estimated concentration for a S.I. of 3.
a,b,c,d = Co-ordinates of the two pair of data lying immediately above and below the S.I.
value of 3 on the LLNA dose response plot.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: See table below
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: See table below
Any other information on results incl. tables
Results:
Vehicle: DMF
Test item concentration % (w/v) |
Group |
Measurement DPM |
DPM-BG a) |
Number of Lymph Nodes |
DPM per Lymph Node b) |
S.I. |
--- |
BG I |
0.0 |
--- |
--- |
--- |
--- |
--- |
BG II |
0.0 |
--- |
--- |
--- |
--- |
--- |
CG 1 |
3336.7 |
3336.7 |
8 |
417.1 |
|
5.0 |
TG 2 |
2414.6 |
2414.6 |
8 |
301.8 |
0.72 |
10.0 |
TG 3 |
2723.4 |
2723.4 |
8 |
340.4 |
0.82 |
25.0 |
TG 4 |
2248.4 |
2248.4 |
8 |
281.1 |
0.67 |
BG = Background (1 ml 5% trichloroacetic acid) in duplicate
CG = Control Group
TG = Test Group
S.I. .= Stimulation Index
a) = The mean value was taken from the figures BG I and BG II
b) = Since the lymph nodes of the animals of a dose group were pooled, DPM/node was determined by dividing the measured value by the number of lymph nodes pooled
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- The test item Acetoacet-o-Chloroanilide was found to be not a skin sensitiser.
- Executive summary:
The LLNA study was documented and performed in year 2004 according to GLP standards and in compliance with OECD Guideline 429: Skin sensitization: Local Lymph Node Assay. As test system Mice, strain CBA/CaOlaHsd was used. Upon sponsor's request the data of and additional validation- / positive control study performed under GLP are included in the study report.
No deaths occurred during the study period. No symptoms of local toxicity at the ears of the animals and no systemic findings were observed during the study period. The body weights of the animals, recorded prior to the 1st application and prior to necropsy was within the range commonly recorded for animals of this strain and age.
The estimated concentration of test item required to produce an S.I. of 3 is referred to as the EC3 value. In this study the EC3 value could not be calculated, since none of the tested concentrations induced an S.I. greater than 3.
Therefore, the test item Acetoaceto- Chloroanilide was not found to be a skin sensitiser.
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