Registration Dossier
Registration Dossier
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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 29/10/1980 to 1/11/1980
- 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:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- This primary dermal irritation study was conducted prior to the adoption of OECD Guideline 404 (original adopted in 1981). However, the study was conducted in accordance with the test facility protocol and US FHSA guidelines available at the time. Study methods and results are well documented in the study report and summarised here.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Benzenesulfonic acid, mono- and dialkylation products with C16-20 (even numbered, branched and linear) olefins
- Molecular formula:
- Cannot be adequately determined for this UVCB substance
- IUPAC Name:
- Benzenesulfonic acid, mono- and dialkylation products with C16-20 (even numbered, branched and linear) olefins
- Test material form:
- liquid
- Details on test material:
- Test material is 65% of the registered substance diluted in 35% non-hazardous mineral oil. E-050 is described in the study reports as a thick, brown oily liquid.
Constituent 1
- Specific details on test material used for the study:
- Test material is 65% of the registered substance diluted in 35% non-hazardous mineral oil. Described in the study reports as a thick, brown oily liquid.
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: B&D Commercial Rabbitry, Malvern, Arkansas
- Age at study initiation: At least 8 weeks old
- Weight at study initiation: 2507-2866 g
- Housing: Individually housed in stainless steel cages, which are elevated above the droppings, in an environmentally controlled room. Rooms and cages maintained in accordance with the standards of the American Association for Accredication of Laboratory Animal Care (AAALAC).
- Diet: Wayne Feeds Rabbit Ration available ad libitum
- Water: Tap water available ad libitum
- Acclimation period: 21 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not reported
- Humidity (%): Not reported
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12 hrs light
IN-LIFE DATES: From: To: 29/10/1980 to 1/11/1980
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: Fur was clipped from the dorsal area of the test animnals at least 24 hours prior to application. Two test sites were used per animal; one site was abraded using a hypodermic needle immediately prior to dosing. The skin of the other site was left intact.
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml per test site - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 72 hours
- Number of animals:
- Six; 3 females and 3 males
- Details on study design:
- TEST SITE
- Area of exposure: 3 cm2 per test site
- % coverage: Not reported
- Type of wrap if used:
Each dose was introduced under a square patch of surgical gauze measuring 1 inch by 1 inch and two single layers thick. Patches secured in place with Coban elastic bandage and Johnson and Johnson Zonas porous adhesive tape. The entire trunk of each animal was then wrapped with an impervious non-reactive material (such as plastic, 2 mils thick) and sealed at both ends to retard evaporation of volatile substances and to prevent the ingestion of the test material. A white cotton towel (15cm x 45cm) was then wrapped over the plastic and secured with Johnson and Johnson Zonas porous tape.
REMOVAL OF TEST SUBSTANCE
After the 24-hour exposure, the patches were removed and the skin was wiped, but not washed (unless necessary to observe the skin) to remove any test substance still remaining.
OBSERVATION TIME POINTS
A 30-minute period was allowed following removal of the test substance for pressure and hydration effects to subside. The animals were then scored for dermal reactions. Test sites were scored again after an additional 48 hours (i.e. 24 and 72-hour time points).
SCORING SYSTEM:
Irritation potential was scored according to the method of Draize (1944), as outlined in the Federal Hazardous Substances Act Grading Code at 16 CFR 1500.41. Primary irritation score was calculated as the total of the average scores for erythema / eschar formation and edema formation at 24- and 72-hours in either intact or abraded skin (8 values) divided by 4.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- other: Primary Irritation score = Total of average scores / 4
- Time point:
- other: 24/72 hr
- Score:
- 5.38
- Reversibility:
- not specified
- Remarks on result:
- other: Primary dermal irritant
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: Severe erythema to slight eschar formation
- Remarks:
- Intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- other: Moderate to severe erythema
- Remarks:
- Intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 2
- Reversibility:
- not specified
- Remarks on result:
- other: Well-defined erythema
- Remarks:
- Intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 2
- Reversibility:
- not specified
- Remarks on result:
- other: Well-defined erythema
- Remarks:
- Intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: Severe erythema to slight eschar formation
- Remarks:
- Intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- other: Moderate to severe erythema
- Remarks:
- Intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24 h
- Score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: Severe erythema to slight eschar formation
- Remarks:
- Intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 72 h
- Score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- other: Moderate to severe erythema
- Remarks:
- Intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24 h
- Score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: Severe erythema to slight eschar formation
- Remarks:
- Intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 72 h
- Score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- other: Moderate to severe erythema
- Remarks:
- Intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24 h
- Score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: Severe erythema to slight eschar formation
- Remarks:
- Intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 72 h
- Score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- other: Moderate to severe erythema
- Remarks:
- Intact skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 3.67
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- probability of severe irritation
- Remarks:
- Intact skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 2.83
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- probability of severe irritation
- Remarks:
- Intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: Severe erythema to slight eschar formation
- Remarks:
- Abraded skin
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: Severe erythema to slight eschar formation
- Remarks:
- Abraded skin
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 2
- Reversibility:
- not specified
- Remarks on result:
- other: Well-defined erythema
- Remarks:
- Abraded skin
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 2
- Reversibility:
- not specified
- Remarks on result:
- other: Well-defined erythema
- Remarks:
- Abraded skin
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: Severe erythema to slight eschar formation
- Remarks:
- Abraded skin
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: Severe erythema to slight eschar formation
- Remarks:
- Abraded skin
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24 h
- Score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: Severe erythema to slight eschar formation
- Remarks:
- Abraded skin
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 72 h
- Score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: Severe erythema to slight eschar formation
- Remarks:
- Abraded skin
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24 h
- Score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: Severe erythema to slight eschar formation
- Remarks:
- Abraded skin
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 72 h
- Score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: Severe erythema to slight eschar formation
- Remarks:
- Abraded skin
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24 h
- Score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: Severe erythema to slight eschar formation
- Remarks:
- Abraded skin
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 72 h
- Score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: Severe erythema to slight eschar formation
- Remarks:
- Abraded skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 3.67
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- probability of severe irritation
- Remarks:
- Abraded skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 3.67
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- probability of severe irritation
- Remarks:
- Abraded skin
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 4
- Reversibility:
- fully reversible within: 72 hours (no 48-hour scoring)
- Remarks on result:
- other: Severe edema
- Remarks:
- Intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Remarks:
- Intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 3
- Reversibility:
- fully reversible within: 72 hours (no 48-hour scoring)
- Remarks on result:
- other: Moderate edema
- Remarks:
- Intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Remarks:
- Intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 4
- Reversibility:
- fully reversible within: 72 hours (no 48-hour scoring)
- Remarks on result:
- other: Severe edema
- Remarks:
- Intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Remarks:
- Intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24 h
- Score:
- 4
- Reversibility:
- fully reversible within: 72 hours (no 48-hour scoring)
- Remarks on result:
- other: Severe edema
- Remarks:
- Intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Remarks:
- Intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24 h
- Score:
- 4
- Reversibility:
- fully reversible within: 72 hours (no 48-hour scoring)
- Remarks on result:
- other: Severe edema
- Remarks:
- Intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Remarks:
- Intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24 h
- Score:
- 4
- Reversibility:
- fully reversible within: 72 hours (no 48-hour scoring)
- Remarks on result:
- other: Severe edema
- Remarks:
- Intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Remarks:
- Intact skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 3.83
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours (no 48-hour scoring)
- Remarks on result:
- probability of severe irritation
- Remarks:
- Intact skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Remarks:
- Intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 4
- Reversibility:
- fully reversible within: 72 hours (no 48-hour scoring)
- Remarks on result:
- other: Severe edema
- Remarks:
- Abraded skin
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Remarks:
- Abraded skin
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 3
- Reversibility:
- fully reversible within: 72 hours (no 48-hour scoring)
- Remarks on result:
- other: Moderate edema
- Remarks:
- Abraded skin
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Remarks:
- Abraded skin
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 4
- Reversibility:
- fully reversible within: 72 hours (no 48-hour scoring)
- Remarks on result:
- other: Severe edema
- Remarks:
- Abraded skin
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Remarks:
- Abraded skin
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24 h
- Score:
- 4
- Reversibility:
- fully reversible within: 72 hours (no 48-hour scoring)
- Remarks on result:
- other: Severe edema
- Remarks:
- Abraded skin
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Remarks:
- Abraded skin
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24 h
- Score:
- 4
- Reversibility:
- fully reversible within: 72 hours (no 48-hour scoring)
- Remarks on result:
- other: Severe edema
- Remarks:
- Abraded skin
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Remarks:
- Abraded skin
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24 h
- Score:
- 4
- Reversibility:
- fully reversible within: 72 hours (no 48-hour scoring)
- Remarks on result:
- other: Severe edema
- Remarks:
- Abraded skin
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Remarks:
- Abraded skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 3.83
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours (no 48-hour scoring)
- Remarks on result:
- probability of severe irritation
- Remarks:
- Abraded skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Remarks:
- Abraded skin
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 48 h
- Reversibility:
- not specified
- Remarks on result:
- not measured/tested
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 48 h
- Reversibility:
- not specified
- Remarks on result:
- not measured/tested
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 48 h
- Reversibility:
- not specified
- Remarks on result:
- not measured/tested
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 48 h
- Reversibility:
- not specified
- Remarks on result:
- not measured/tested
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 48 h
- Reversibility:
- not specified
- Remarks on result:
- not measured/tested
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 48 h
- Reversibility:
- not specified
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 48 h
- Reversibility:
- not specified
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 48 h
- Reversibility:
- not specified
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 48 h
- Reversibility:
- not specified
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 48 h
- Reversibility:
- not specified
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 48 h
- Reversibility:
- not specified
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 48 h
- Reversibility:
- not specified
- Remarks on result:
- not measured/tested
- Other effects:
- No abnormal behaviour was noted in any animal during the conduct of this study.
Any other information on results incl. tables
Primary irritation scores in six rabbits following a 24 -hour exposure:
Skin condition |
Time (hr) |
Animal number / sex |
Total score |
Average score |
|||||
|
1/M |
2/M |
3/M |
4/F |
5/F |
6/F |
|||
Erythema and Eschar formation |
|||||||||
Intact |
24 |
4 |
2 |
4 |
4 |
4 |
4 |
22 |
3.67 |
Intact |
72 |
3 |
2 |
3 |
3 |
3 |
3 |
17 |
2.83 |
Abraded |
24 |
4 |
2 |
4 |
4 |
4 |
4 |
22 |
3.67 |
Abraded |
72 |
4 |
2 |
4 |
4 |
4 |
4 |
22 |
3.67 |
Edema formation |
|||||||||
Intact |
24 |
4 |
3 |
4 |
4 |
4 |
4 |
23 |
3.83 |
Intact |
72 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Abraded |
24 |
4 |
3 |
4 |
4 |
4 |
4 |
23 |
3.83 |
Abraded |
72 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (corrosive) based on GHS criteria
- Conclusions:
- A primary irritation score of 5.38 was calculated. The test substance was therefore considered to be a primary dermal irritant according to the FHSA Regulations at 16 CFR 1500.3, as referenced in the study report. Severe erythema was observed at both the 24- and 72-hour timepoints in intact and abraded skin. Severe edema was noted at the 24-hour time point but was reversible within 72-hours. Due to the lack of 14-day observation period in this study, it is unclear whether the erythema would be reversible after a longer period of time. Therefore, as a worst case, the test substance is classified as Category 1 for skin corrosion/irritation under GHS and CLP. There is insufficient information to subcategorise.
- Executive summary:
A study was conducted in order to evaluate the dermal irritation potential of the test substance in six New Zealand White rabbits (3/sex). The test sites were prepared by clipping the fur (dorsal trunk area) 24 hours prior to treatment. Two test sites (each approximately 3 cm2) were prepared within the clipped area per animal; one to the left of the spinal column and one to the right, with at least 3 cm of separation between test sites. On one site the skin was abraded immediately prior to treatment and on the other the skin was left intact. A dose of 0.5 ml test substance was applied to each site under semi-occlusive conditions for 24 hours. Following the exposure period, the test area was wiped and a 30 -minute period allowed for pressure and hydration effects to subside. The test areas were then scored for dermal reactions (erythema and edema). The animals were observed for an additional 48 hours (72 hours total) and the dermal reactions were then scored again. At the 24-hour time point, well-defined erythema to severe erythema was observed at both the intact and abraded test sites, as well as edema ranging from moderate to severe. At the 72 -hour time point, erythema ranged from well-defined to severe but no edema was noted. Due to the lack of 14-day observation period in this study, it is unclear whether the erythema would be reversible after a longer period of time. Therefore, as a worst case, the test substance is classified as Category 1 for skin corrosion/irritation under GHS and CLP. There is insufficient information to subcategorise.
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