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EC number: 238-874-2 | CAS number: 14806-72-5
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1996-06-28 to 1996-08-07
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study performed according to Guidelines. Thia study also meets with GLP Regulations, 21 CFR, Part 58, July 1991.The study is the result of a structural analogue substance used as read-across substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
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:
- other: Toxic Substance Control Act (TSCA), 40 CFR, Part 798, Subpart E, Specific Organ/Tissue Toxicity, Primary Dermal Irritation, Section 798, 4470, Juy, 1993
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- Self certified
Test material
- Reference substance name:
- -
- EC Number:
- 427-360-5
- EC Name:
- -
- IUPAC Name:
- 427-360-5
- Details on test material:
- - Description: yellow solid.
- Stability: Stable
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Test animals –
Species: Rabbit
Strain: New Zealand White
Weight/Age range: Betwwen 2.0 and 3.0 kg (10 to 12 weeks old) weighed to the nearest 10gm.
Source: Registered commercial breeder.
Acclimatisation period: At least 5 days under test conditions
Diet: Commercial rabbit ration ad libitum
Water: Tap water ad libitum
Housing: Individually housed
Environmental conditions
Temperature: 68 ±5 °F
Humidity: 30 - 70 %
Air changes: 10 - 15 per hour
Photoperiod: 12-hour light/dark cycle, full spectrum fluorescent
Test system
- Type of coverage:
- other: A bandage was used to keep the test substance in contact with the skin. No data has been provided on whether it was semi-occlusive or occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- The test substance (0.5 grams) was applied to each application site. Seperate animals were not required for an untreated control group.
- Duration of treatment / exposure:
- Four hours
- Observation period:
- 72 hours
- Number of animals:
- Six rabbits (3 male and 3 female)
- Details on study design:
- 24 hours prior to test application, fur was removed from a group of 6 albino rabbits by clipping the skin of the trunk of the animals free of hair within 24 hours prior to application of the test substance. 0.5 g of the test substance was applied directly to each application site, and was secured using a bandage. 4 hours later, the bandage was removed.
Animals were observed for signs of erythema and edema at 30 - 60 minutes and then at 24, 48 and 72 hours after bandage removal. Observations were scored according to the Draize Scale for scoring skin reactions.
Animals were observed daily for mortality/clinical signs. Bodyweights were measured on day 0 and day 3.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 4 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- No signs of erythema were noted at any of the observation periods. The test sites did not exhibit signs of oedema during the observation period.
- Other effects:
- No rabbits died during the course of the study. There were no overt signs of toxicity during the course of the study and all six animals exhibited a gain in body weight during the observation period.
Any other information on results incl. tables
Table 1: Animal weights and clinical observations.
|
|
Body Weight (Kg) |
|
||
Animal # |
Sex |
Day 0 |
Day 3 |
Weight Change |
Signs of Toxicity* |
60905 |
Male |
2.51 |
2.56 |
0.05 |
None |
60906 |
Female |
2.27 |
2.31 |
0.04 |
None |
60907 |
Male |
2.86 |
2.90 |
0.04 |
None |
60908 |
Female |
2.48 |
2.53 |
0.05 |
None |
60909 |
Male |
2.93 |
2.96 |
0.03 |
None |
60910 |
Female |
2.88 |
2.93 |
0.05 |
None |
|
|
|
|
|
|
*Excluding erythema and edema observations at 30-60 minutes after the 4 hour exposure. 24, 48 and 72h
Table IIA: Draize scores
Animal# |
30/07/96 4 Hours* |
31/07/96 24 Hours |
01/08/96 48 Hours |
02/08/96 72 Hours |
Total Divided by 4 |
60905 |
0/0 |
0/0 |
0/0 |
0/0 |
0.0 |
60906 |
0/0 |
0/0 |
0/0 |
0/0 |
0.0 |
60907 |
0/0 |
0/0 |
0/0 |
0/0 |
0.0 |
60908 |
0/0 |
0/0 |
0/0 |
0/0 |
0.0 |
60909 |
0/0 |
0/0 |
0/0 |
0/0 |
0.0 |
60910 |
0/0 |
0/0 |
0/0 |
0/0 |
0.0 |
Primary Dermal Irritation Index (PDII) = 0.0
Note: PDII equals sum for all animals divided by 6.
*taken 30-60 minutes after the 4 hour exposure treatment.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- According to the established criteria and guidelines, the test substance is considered a non-irritant to the skin of New Zealand White rabbits.
- Executive summary:
The Read Across test substance RA2 was tested for its dermal irrtancy potential.
6 albino rabbits (3/sex) were prepared by clipping the skin of the trunk free of hair. 24 hours later, 0.5 grams of test substance was applied in a single dose application to the skin of the rabbits for 4 hours.
No mortalities or clinical signs were seen. There was no evidence of erythema or oedema at any of the observation periods.
Based on these results, the test substance is considered not to be a skin irritant.
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