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EC number: 259-210-8 | CAS number: 54546-26-8
- 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:
- The study was conducted in 1980.
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Meets generally accepted scientific standards with acceptable restrictions.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- not specified
- Principles of method if other than guideline:
- Primary irritation to the skin is measured by a patch-test technique on the abraded and intact skin of albino rabbits.
- GLP compliance:
- no
- Remarks:
- The study pre-dates GLP.
Test material
- Reference substance name:
- Herboxane
- IUPAC Name:
- Herboxane
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material: Herboxane
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: Intact and abraded skin
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 72 hours
- Number of animals:
- 12 rabbits
- Details on study design:
- Protocol for Primary skin irritation test
Primary irritation to the skin is measured by a patch-test technique on the abraded and intact skin of albino rabbits.
Twelve healthy adult New Zealand White albino rabbits are used for 1 - 4 test substances. Twenty four hours prior to applying the materials, the hair is removed from the backs of the animals with an electric clipper in such a way as to avoid abrasions.
An amount of 0.5 ml (in case of liquids) or 0.5 g (in case of solids or semi-solids) of the test substance is brought on the intact or abraded skin under a surgical patch measuring l inch x 1 inch. The patches are fixed to the application site by means of adhesive tape and the entire trunk of the rabbits is wrapped with an impervious material to maintain the test patches in position and to retard evaporation of volatile substances.
Six rabbits are treated on the intact skin, the other six on the abraded skin. The abrasions are minor incisions through the stratum corneum, but not sufficiently deep to disturb the derma or to produce bleeding. After an exposure period of 24 hours the patches and the material applied are removed and the resulting skin reactions are evaluated by the method of Draize (J. Pharmacol. 82 (1944) 377 - 390). A second reading is made 48 hours later (72 hours after application).
In the case of surface active test substances the skin reactions after 72 hours usually consist of scaliness and or necrosis. Since the Draize grading system does not comprise these abnormalities the second reading is carried out on the basis of the CIVO grading system.
Evaluation of skin reactions (Draize) Value
A. Erythema and eschar formation
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
B. 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 millimeter) 3
Severe edema (raised more than 1 millimeter and extending beyond the area of exposure) 4
Total possible score for primary irritation: 8 (4 + 4)
Evaluation of skin reactions (CIVO) Value
No reaction at all 0
Very slight scaliness 1
Distinct scaliness or very slight incrustation 2
Distinct incrustation 3
Severe incrustation 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other: Intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal: 8416
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other: Intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal: 8417
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal: 8418
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other: Intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal: 8419
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other: Intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal: 8420
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other: Intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal: 8421
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other: Intact skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0.16
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other: Intact skin
- Irritation parameter:
- edema score
- Basis:
- animal: 8416
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Intact skin
- Irritation parameter:
- edema score
- Basis:
- animal: 8417
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Intact skin
- Irritation parameter:
- edema score
- Basis:
- animal: 8418
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Intact skin
- Irritation parameter:
- edema score
- Basis:
- animal: 8419
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Intact skin
- Irritation parameter:
- edema score
- Basis:
- animal: 8420
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other: Intact skin
- Irritation parameter:
- edema score
- Basis:
- animal: 8421
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Intact skin
- Irritation parameter:
- other: Evaluation of Skin Reaction - CIVO
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other: Intact skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 1.6
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other: Abraded skin. One animal died during the test.
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0.2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other: Abraded skin. One animal died during the test.
- Irritation parameter:
- other: Evaluation of Skin Reaction - CIVO
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 1.4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other: Abraded skin. One animal died during the test.
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.25
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: score based on 24h and 72h skin observation (not measured at 48h)
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.25
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: Score based on skin observation at 24h and 72h (not measured at 48h)
- Irritant / corrosive response data:
- The skin reactions observed after 24 hours consisted of very slight erythema or well—defined erythema together with very slight edema.
The skin reactions observed after 72 hours consisted of slight to distinct scaliness.
There were no distinct differences between the skin reactions of the intact skin and those of the abraded skin.
From the results of the primary skin irritation test it is concluded that Herboxane is a slight primary skin irritant.
Any other information on results incl. tables
One rabbit died during the exposure period probably because of amechanical trauma.
The individual and average skin irritation scores are presented inthe table below:
Rabbit Number |
Intact Skin |
Rabbit Number |
Abraded Skin |
||||
24 hr |
72 hr |
24 hr |
72 hr |
||||
a |
b |
a |
b |
||||
8416 |
1 |
0 |
2 |
8410 |
1 |
0 |
2 |
8417 |
0 |
0 |
0 |
8411 |
* |
* |
* |
8418 |
1 |
0 |
1 |
8412 |
4 |
1 |
1 |
8419 |
1 |
0 |
2 |
8413 |
1 |
0 |
2 |
8420 |
2 |
1 |
2 |
8414 |
1 |
0 |
0 |
8421 |
1 |
0 |
1 |
8415 |
1 |
0 |
2 |
average |
1.2 |
1.3 |
1.4 |
1.4 |
Where: A=erythema, B=edema, *=dead
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- It was concluded that Herboxane is a slight primary skin irritant
- Executive summary:
The product Herboxane was examined for primary skin irritating properties and acute dermal toxicity in experiments with albino rabbits.
It was concluded that Herboxane is a slight primary skin irritant.
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