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Reactions mass of N-{2-[(4-bromo-6-substituted-2-alkyl-1,3-dioxo-2,3-dihydro-1H-isoindol-5-yl)diazenyl]-[alkyl(2-methoxyalkyl)amino]phenyl}acetamide) and N-{2-[(4-bromo-6-substiuted-2-alkyl-1,3-dioxo-2,3-dihydro-1H-isoindol-5-yl)diazenyl]-[alkyl(2-hydroxy-3-phenoxypropyl)amino]phenyl}acetamide
EC number: - | CAS number: -
- 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
- Study period:
- 10 June 2014 to 13 June 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Two New Zealand White (Hsdlf:NZW) strain rabbits were supplied by Harlan Laboratories UK Ltd., Leicestershire, UK. At the start of the study the animals weighed 2.90 and 2.95 kg and were twelve to twenty weeks old. After an acclimatization period of at least five days each animal was given a number unique within the study which was written with a black indelible marker pen on the inner surface of the ear and on the cage label.
The animals were individually housed in suspended cages. Free access to mains drinking water and food (2930C Teklad Global Rabbit diet supplied by Harlan Laboratories UK Ltd., Oxon, UK) was allowed throughout the study. The diet and drinking water were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.
The temperature and relative humidity were set to achieve limits of 17 to 23 °C and 30 to 70% respectively. The rate of air exchange was at least fifteen changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.
The animals were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 g of the test item, moistened sufficiently with 0.5 mL of distilled water
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 2
- Details on study design:
- On the day before the test two rabbits were clipped free of fur from the dorsal/flank area using veterinary clippers. Only animals with a healthy intact epidermis by gross observation were selected for the study.
On the day of the test a suitable test site was selected on the back of each rabbit. At each test site a quantity of 0.5 g of the test item, moistened sufficiently with 0.5 mL of distilled water was introduced under a 2.5 cm x 2.5 cm cotton gauze patch. The patch was secured in position with a strip of surgical adhesive tape. To prevent the animals interfering with the patches, the trunk of each rabbit was wrapped in an elasticated corset and the animals were returned to their cages for the duration of the exposure period.
Four hours after application the corset and patches were removed from each animal and any residual test item removed by gentle swabbing with cotton wool soaked in distilled water.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: Erythema/Eschar Formation
- Basis:
- animal: 74369 Female
- Time point:
- other: Highest score at 24, 48 and 72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: Black staining observed up to 1 hour after patch removal
- Irritation parameter:
- other: Erythema/Eschar Formation
- Basis:
- animal: 74370 Female
- Time point:
- other: Gighest score at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No evidence of skin irritation
- Remarks on result:
- other: Black staining observed up to 72 hours after patch removal
- Irritation parameter:
- other: Oedema Formation
- Basis:
- animal: 74369 Female
- Time point:
- other: Highest score at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No evidence of skin irritation
- Irritation parameter:
- other: Oedema Formation
- Basis:
- animal: 74370 Female
- Time point:
- other: Highest score at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No evidence of skin irritation
- Irritant / corrosive response data:
- The individual scores for erythema/eschar and edema are given in Table 1.
Black staining, not preventing evaluation of skin responses, was noted at both treated skin sites during the study.
Very slight erythema was noted at one treated skin site at the 24 Hour observation.
No evidence of skin irritation was noted during the study. - Other effects:
- Individual body weights and body weight change are given in Table 2.
Both animals showed expected gain in body weight during the study.
Any other information on results incl. tables
Calculation of Primary Irritation Index and Grading of Irritancy Potential Using the Draize Scheme
The scores for erythema and edema at the 24 and 72‑Hour readings were totaled for the two test rabbits (8 values) and this total was divided by 4 to give the primary irritation index of the test item. The test item was classified according to the following scheme devised byDraize, J.H. (1959):
Primary Irritation Index |
Classification of Irritancy |
0 |
Non-irritant |
> 0 to 2 |
Mild irritant |
> 2 to 5 |
Moderate irritant |
> 5 to 8 |
Severe irritant |
If irreversible alteration of the dermal tissue is noted in any rabbit, as judged by the Study Director, which include ulceration and clear necrosis or signs of scar tissue, the test item is classified as corrosive to rabbit skin. Classification according to Draize may, therefore, not be applicable.
The results were also interpreted according to the Regulation (EC) No 1272/2008, relating to the Classification, Labelling and Packaging of Substances and Mixtures.
Table 1 Individual Skin Reactions
Skin Reaction |
Observation Time |
Individual Scores – |
Total |
|
74369 Female |
74370 Female |
|||
Erythema / Eschar Formation |
Immediately |
0STA |
0STA |
(0 ) |
1 Hour |
0STA |
0STA |
( 0 ) |
|
24 Hours |
1 |
0STA |
1 |
|
48 Hours |
0 |
0STA |
( 0 ) |
|
72 Hours |
0 |
0STA |
0 |
|
Edema Formation |
Immediately |
0 |
0 |
( 0 ) |
1 Hour |
0 |
0 |
( 0 ) |
|
24 Hours |
0 |
0 |
0 |
|
48 Hours |
0 |
0 |
( 0 ) |
|
72 Hours |
0 |
0 |
0 |
|
Sum of 24 and 72‑Hour Readings (S) : 1 |
||||
Primary Irritation Index (S/4) : 1/4 = 0.3 |
||||
Classification : MILD IRRITANT |
( ) = Total values not used for calculation of primary irritation index
STA = Black staining
Table 2 Individual Body Weights and Body Weight Change
Rabbit Number |
Individual Body Weight (kg) |
Body Weight Change (kg) |
|
Day 0 |
Day 3 |
||
74369 |
2.95 |
3.05 |
0.10 |
74370 |
2.90 |
2.98 |
0.08 |
Applicant's summary and conclusion
- Interpretation of results:
- other: The test item produced a primary irritation index of 0.3 and was classified as a mild irritant to rabbit skin according to the Draize classification scheme.
- Remarks:
- Criteria used for interpretation of results: other: Draize classification scheme.
- Conclusions:
- The test item produced a primary irritation index of 0.3 and was classified as a mild irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.
The test item does not meet the criteria for classification according to Regulation (EC) No 1272/2008, relating to the Classification, Labelling and Packaging of Substances and Mixtures - Executive summary:
Introduction
The study was performed to assess the irritancy potential of the test item to the skin of the New Zealand White rabbit.
Results
A single 4‑Hour, semi‑occluded application of the test item to the intact skin of two rabbits produced very slight erythema at one treated skin site at the 24‑Hour observation. No evidence of skin irritation was noted at the other treated skin site during the study
Conclusion
The test item produced a primary irritation index of 0.3 and was classified as a mild irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.
The test item does not meet the criteria for classification according to Regulation (EC) No 1272/2008, relating to the Classification, Labelling and Packaging of Substances and Mixtures.
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