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Diss Factsheets
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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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
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:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study follows acceptable practices. Conducted prior to GLP regulations.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 977
- Report date:
- 1977
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Guidelines established by the US Federal Hazardous Substances Act (1973)
- Deviations:
- not specified
- GLP compliance:
- no
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Test material form:
- other: viscous, applied as 50% in light paraffinic petroleum oil as placed on the market
- Details on test material:
- 50% DNNSA (DI C8-C10, BRANCHED, C9 RICH, ALKYLNAPHTHALENE SULFONIC ACID)
50% light paraffinic petroleum oil
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Six healthy mature male albino rabbits of the New Zealand variety were selected from the stock colony.
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: 6 sites abraded and 6 sites intact skin
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 ml of 50% solution in light paraffinic petroleum oil
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 24 and 72 hours
- Number of animals:
- 6
- Details on study design:
- Prior to application of the sample, the backs were
clipped free of hair. The skin was left intact at six test sites and was
abraded on the other six. 0.5 ml of a liquid test material was
applied to an area of skin approximately 1 inch square on each rabbit. Patches
of surgical gauze measuring 1 inch square, 2 single layers thick, were applied
over the samples and covered with a non-reactive tape. The rabbits were then
wrapped with a rubber dam.
After the 24-hour exposure, the dam and tape were removed and the skin reactions
evaluated. An evaluation was also made at 72 hours after application.
The reactions were scored according to the methods described in the Federal
Hazardous Substances Act.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- other: 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- no data
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- other: 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- no data
- Remarks on result:
- other: abraded skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- other: 24 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- no data
- Remarks on result:
- other: intact skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- other: 24 h
- Score:
- 1.83
- Max. score:
- 4
- Reversibility:
- no data
- Remarks on result:
- other: abraded skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- other: 72 h
- Score:
- 2.16
- Max. score:
- 4
- Reversibility:
- no data
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- other: 72 h
- Score:
- 2.16
- Max. score:
- 4
- Reversibility:
- no data
- Remarks on result:
- other: abraded skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- other: 72 h
- Score:
- 2.16
- Max. score:
- 4
- Reversibility:
- no data
- Remarks on result:
- other: intact skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- other: 72 h
- Score:
- 2.16
- Max. score:
- 4
- Reversibility:
- no data
- Remarks on result:
- other: abraded skin
- Irritant / corrosive response data:
- The primary irritation index was 4.04, moderate irritation. It would not be considered a primary skin irritant.
INDEX Evaluation
0 No irritation
0.04 to 0.99 Irritation barely perceptible
1.00 to 1.99 Slight irritation
2.00 to 2.99 Mi ld irritation
3.00 to 5.99 Moderate irritation
6.00 to 8.00 Severe irritation
Any other information on results incl. tables
RABBIT NO. |
24 HOURS |
72 HOURS |
||||||
INTACT |
ABRADED |
INTACT |
ABRADED |
|||||
ERYTHEMA |
EDEMA |
ERYTHEMA |
EDEMA |
ERYTHENA |
EDEMA |
ERYTHEMA |
EDEMA |
|
A |
B |
C |
D |
E |
F |
G |
H |
|
2582 |
1 |
2 |
1 |
2 |
2 |
2 |
2 |
2 |
2583 |
2 |
2 |
2 |
2 |
2 |
2 |
2 |
2 |
2584 |
1 |
2 |
2 |
2 |
1 |
2 |
1 |
2 |
2585 |
2 |
2 |
2 |
2 |
3 |
3 |
3 |
3 |
2586 |
2 |
2 |
2 |
2 |
2 |
2 |
2 |
2 |
2587 |
2 |
2 |
2 |
2 |
3 |
2 |
3 |
2 |
TOTAL |
10 |
12 |
11 |
12 |
13 |
13 |
13 |
13 |
PRIMARY IRRITATION INDEX = ( sum of individual totals, each divided by 6 ) divided by 4 = 4.04
Scoring of Irritation
Evaluation of Skin Reaction |
|
Erythema and eschar formation: |
Value |
No erythema |
0 |
Very slight erythema (barely perceptible) |
1 |
Well-defined erythema |
2 |
Moderate to severe erythema |
3 |
Severe erythema (beet redness) to slight eschar formation (injuries in depth) |
4 |
|
|
Edema formation: |
|
No edema |
0 |
Very slight edema (barely perceptible) |
1 |
Slight edema (edges of area well defined by definite raising) |
2 |
|
|
Moderate edema (raised approximately 1 mm) |
3 |
|
|
Severe edema (raised more than 1 mm) and extending beyond the area of exposure |
4 |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The substance is a moderate skin irritant but according to classification criteria as defined in GHS and CLP not subject to classification.
- Executive summary:
A 50% DNNSA formulation in light paraffinic petroleum oil was tested on six healthy mature male albino rabbits (New Zealand variety) for evaluation of primary irritation. Prior to application of the sample, the backs were clipped free of hair. The skin was left intact at six test sites and was abraded on the other six. 0.5 ml of a liquid test material was applied to an area of skin approximately 1 inch square on each rabbit. Patches of surgical gauze measuring 1 inch square, 2 single layers thick, were applied over the samples and covered with a non-reactive tape. The rabbits were then wrapped with a rubber dam. After the 24-hour exposure, the dam and tape were removed and the skin reactions evaluated. An evaluation was also made at 72 hours after application. The reactions were scored according to the methods described in the Federal Hazardous Substances Act.
RESULTS
The primary irritation index was 4.04 indicating moderate irritation.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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