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EC number: 201-972-0 | CAS number: 90-17-5
- 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
Skin irritation / corrosion
Administrative data
- 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:
- comparable to guideline study
- Justification for type of information:
- Data is from experimental study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- The test is designed to investigate the irritation effects of substances when applied once to the intact skin under a semi-occlusive dressing.
- GLP compliance:
- no
Test material
- Reference substance name:
- 2,2,2-trichloro-1-phenylethyl acetate
- EC Number:
- 201-972-0
- EC Name:
- 2,2,2-trichloro-1-phenylethyl acetate
- Cas Number:
- 90-17-5
- Molecular formula:
- C10H9Cl3O2
- IUPAC Name:
- 2,2,2-trichloro-1-phenylethyl acetate
- Test material form:
- solid: crystalline
- Details on test material:
- - Name of test material: 2, 2, 2-trichloro-1-phenylethyl acetate
- Molecular formula: C10H9Cl3O2
- Molecular weight: 267.54
- Substance type: Organic
- Physical state: Solid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- - Age at study initiation: 9-12 weeks
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- 0.5 ml of each test and std. solution (0.2 gm for solid samples)
- Duration of treatment / exposure:
- 7 days
- Observation period:
- 24,48 and 72 hours after treatment, and occasionally up to 7 days
- Number of animals:
- 8 animals
- Details on study design:
- TEST SITE
- Area of exposure: -clipped dorsum of each rabbit
- Type of wrap if used:Occlusive patches are prepared by attaching a piece of thin flexible polythene (3cm x 3cm) to a piece of zinc oxide plaster 9cm x 2.5cm. A 2.5 cm square of cotton gauze (8 ply folded in two) is laid on the polythene such that the edges of the pad are attached to the zinc oxide plaster
REMOVAL OF TEST SUBSTANCE
- Washing (if done): treated areas were wiped clean of excess material.
- Time after start of exposure: sites were evaluated at 24, 48 and 72 hours after treatment, and occasionally up to 7 days after treatment
SCORING SYSTEM: The wilcoxon matched - pairs signed ranks test, which consideres the size and direction of differences between reactions is used to test the significance of differences between pairs of treatment groups.
other: The whole dorsal surface is clipped 3-4 days before the test is due to start and animals in the telogen phase of hair growth are selected. Test solutions (0.5 ml) are applied to a dry patch. Test solids are applied to a moistened patch. Aerosol preparations are applied directly to the skin with two 1 second burst and the patches are saturated with spray which acts as a reservoir.
The patches are firmly attached to ensure good contact between the skin and test substance. The animals are immobilised in a canvas body sleeve for 4 hours after application of the patch. When the patches are removed, the treatment sites are wiped clean of excess material. The position of treatment sites are randomised.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Remarks:
- Test chemical
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 11
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: By 48 and 72 hours there were no visible macroscopic changes.
- Irritation parameter:
- other: Mean Score per site
- Remarks:
- test chemical
- Basis:
- mean
- Time point:
- other: 4/24/48/72 h
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- other: Mean score per site per day
- Basis:
- mean
- Time point:
- other: 4/24/48/72 h
- Score:
- 0.34
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- A single application of the test chemical produced marginal erythema in a few animals and marginal edema in one animal at 24 hours. By 48 and 72 hours there were no visible macroscopic changes.
Any other information on results incl. tables
Table 2: Daily microscopic assessment of irritation reaction of Test Chemical
|
Note:
er |
Erythema |
oe |
Oedema |
cr |
Cracking |
sc |
Scaling |
sb |
Scabbing |
ex |
Exudate |
hae |
Haemorrahage |
Reaction grades and scores:
Marginal/very slight |
1 |
Slight |
2 |
Fairly distinct |
3 |
Quite distinct |
4 |
Becoming well developed |
6 |
Well developed |
8 |
Becoming severe |
10 |
Severe |
12 |
Table 3: Total Irritation Scores
Rabbit number |
Treatment groups |
|||||
C |
B |
D |
A |
F |
E |
|
1144 |
0 |
2 |
1 |
26 |
21 |
27 |
1145 |
3 |
0 |
1 |
38 |
45 |
40 |
1146 |
1 |
4 |
2 |
34 |
26 |
33 |
1147 |
1 |
1 |
2 |
25 |
31 |
31 |
1092 |
0 |
1 |
2 |
18 |
30 |
31 |
1101 |
1 |
0 |
9 |
21 |
24 |
22 |
1163 |
0 |
0 |
3 |
26 |
44 |
39 |
1164 |
4 |
3 |
3 |
25 |
15 |
19 |
Overall irritation score |
10 |
11 |
23 |
213 |
236 |
242 |
Mean score per site |
1.25 |
1.38 |
2.88 |
26.63 |
29.5 |
30.25 |
Mean score per site per day |
0.31 |
0.34 |
0.72 |
6.66 |
7.38 |
7.56 |
Mean Irritation Ranking |
1.75 |
1.81 |
2.44 |
4.63 |
5.06 |
5.31 |
Reaction Grades and Score
a- Marginal/very slight = 1
b- Slight = 2
c- Fairly distinct = 3
d- Quite distinct = 4
e- Becoming well developed = 6
f- Well developed = 8
g- becoming severe = 10
h- severe = 12
Applicant's summary and conclusion
- Interpretation of results:
- other: Not Irritating
- Conclusions:
- A single application of the test chemical produced marginal erythema in a few animals and marginal edema in one animal at 24 hours. By 48 and 72 hours there were no visible macroscopic changes. The mean score per site per day for test chemical was calculated to be 0.34. Based on the scores and observations, the test material can be considered as not irritating to New Zealand White rabbit skin.
- Executive summary:
The test is designed to investigate the irritation effects of when applied once to the intact skin under a semi-occlusive dressing. Eight New Zealand White rabbits were used for the study.
in this test, the dorsal surface was clipped 3 -4 days before the test was due to start. Occlusive patches were prepared by attaching a piece of thin flexible polythene (3*3 cm) to a piece of zinc oxide plaster 9cm*2.5cm. A 2.5 cm square of cotton gauze was laid on the polythene such that the edges of the pad are attached to the zinc oxide plaster. 0.2 gm of undiluted test chemical on a patch dampened with Diethyl Phthalate and 0.5ml of the standards for comparison were applied to the clipped dorsum of rabbits for 4 hours under individual semi-occlusive patches. Bromostyrene, Coumarin, Diethyl phthalate, Cyclamen aldehyde and Geraniol were used as standards for comparison.
Four hours after exposure, the patches were removed and the test sites were wiped cleaned of the excess test material. The sites were scored for erythema, edema, cracking and scaling and any other feature using an 8 point grading scale ranging from "a" (very slight) to "h"(very severe). At the end of the test the reaction grades which were used to calculate the total irritation score per site, a mean irritation score per site per day for each treatment group.
A single application of the test chemical produced marginal erythema in a few animals and marginal edema in one animal at 24 hours. By 48 and 72 hours there were no visible macroscopic changes. The response was similar to that produced by Coumarin and Diethyl phthalate, but considerably less than that produced by Geraniol and Cyclamen aldehyde.
The mean score per site per day for test chemical was calculated to be 0.34.
Based on the scores and observations, the test material can be considered as not irritating to New Zealand White rabbit skin.
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