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Diss Factsheets
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EC number: 916-540-3 | 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
- Remarks:
- source of read across
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Principles of method if other than guideline:
- The test was carried out according to the method given in the "Hazardous Substances Regulations" under the U.S. Federal Hazardous Substances Labelling Act Sect. 191.11 (February 1965).
- GLP compliance:
- no
Test material
- Reference substance name:
- Similar Substance 02
- IUPAC Name:
- Similar Substance 02
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 9 - 13 weeks.
- Weight at study initiation: average 2.05 kg males and 2.22 kg females.
- Housing: rabbits were caged singly.
- Diet: commercial irradiated diet (Styles-Oxoid), ad libitum.
- Water: sterile filtered water, ad libitum.
- Acclimation period: one week prior to the start of the trial.
ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 1 °C
- Relative humidity: 50 - 70 %
- Photoperiod: animals were exposed to artificial light for 10 hours daily from 08.00 - 18.00 hours.
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved and abraded
- Vehicle:
- water
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- Amount: 0.5 g
Fromulaiton: 10 g.of the test compound was mixed with 10 ml of water to make a solution of 15 ml, 0.75 ml of which was applied to each test site on a 2.5 cm square gauze pad. - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 72 hours
- Number of animals:
- 3 males and 3 females
- Details on study design:
- TEST SITE
- Area of exposure: 24 hours prior to the dermal application, the backs of the rabbits were shaved. Two test sites lateral to the mid line of the back were used on each rabbit. Immediately before the application of the test compound, the right hand site was abraded uith the point of a sterile hypodermic needle. The abrasions were sufficiently deep to penetrate the stratum corneum but not to damage the dermis.
- % coverage: at least 10 % of the total body surface.
- Type of wrap if used: animals were covered with aluminium foil secured with "Sleek" adhesive tape. The test sites were then enclosed by a 6 wide "Coban" self adhesive bandage the edges of which were fixed to the skin by strips of "Sleek" in order to retain the test substance in close contact with the skin.
OBSERVATION TIME POINTS
After 24 hours the dressing was removed and the intact and abraded application sites were assessed for oedema and erythema. A further assessment wes made at 72 hours.
SCORING SYSTEM
Erythema and Eschar Formation
No erythema 0
Slight erythema (barely perceptible) 1
Well defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet red) to slight eschar formation 4
Oedema Formation
No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well defined by definite raising) 2
Moderate oedema (raised approximately 1 mm) 3
Severe-oedema (raised more than 1 mm and extending beyond the area of exposure) 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: 6/6
- Remarks:
- both intact and abraded
- Time point:
- 24/48/72 h
- Score:
- < 2.3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Basis:
- animal: 6/6
- Remarks:
- both intact and abraded
- Time point:
- 24/48/72 h
- Score:
- < 2.3
- Irritant / corrosive response data:
- A slight to well defined erythema and a very slight to slight oedema was seen in all rabbits 24 hours after application of the compound. A very slight oedema was still present in 3/6 rabbits at 72 hours. Also at this time 3/6 (No. 11, 14, 15) rabbits were showing slight desquamation of the epidermis at the application sites.
There was no significant difference between intact and abraded sites.
The primary irritation score was 1.6.
Any other information on results incl. tables
Animal N. | Reaction | Itact skin | Itact skin | ||
24 hrs | 72 hrs | 24 hrs | 72 hrs | ||
11 male | Erythema | 1 | 0 | 1 | 0 |
13 male | 1 | 0 | 1 | 0 | |
15 male | 1 | 0 | 1 | 0 | |
12 female | 1 | 0 | 1 | 0 | |
14 female | 2 | 0 | 2 | 0 | |
16 female | 1 | 0 | 1 | 0 | |
11 male | Oedema | 2 | 0 | 1 | 0 |
13 male | 2 | 0 | 2 | 1 | |
15 male | 2 | 1 | 1 | 1 | |
12 female | 2 | 0 | 1 | 0 | |
14 female | 2 | 0 | 2 | 0 | |
16 female | 1 | 1 | 2 | 1 |
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified, according to the CLP Regulation (EC) No 1272/2008
- Conclusions:
- Mild irritating
- Executive summary:
The skin irritation potential of test item was assessed in six New Zealand White rabbits. The test was carried out according to the method given in the "Hazardous Substances Regulations" under the U.S. Federal Hazardous Substances Labelling Act Sect. 191.11 (February 1965).
A slight to well defined erythema and a very slight to slight oedema was seen in all rabbits 24 hours after application of the compound. A very slight oedema was still present in 3/6 rabbits at 72 hours. Also at this time 3/6 (No. 11, 14, 15) rabbits were showing slight desquamation of the epidermis at the application sites.
There was no significant difference between intact and abraded sites.
The primary irritation score was 1.6.
Conclusion
The scoring system criteria used to record the hardness of the skin reactions followed in the current test are the same as those reported into the OECD guideline, therefore it is possible to re-evaluate the results in accordance with the CLP Regulation (EC) No 1272/2008. Althought the observation time points were 24 and 72 hours, the mean scores for grading at 24, 48 and 72 hours can be reasonably estimated.
The mean values from gradings at 24, 48 and 72 hours were lower than lower than 2.3 for both erythema and oedema, in all the tested animals, both with skin shaved and scarified. Therefore, the substance does not meet the criteria to be classified as eye irritating, according to the CLP Regulation (EC) No 1272/2008.
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