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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- The study was conducted in July 1981.
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Meets generally accepted scientific standards with acceptable restrictions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: FDA of the United. States (Fed. Reg. 28 (119), 5582, 1963)
- Deviations:
- not specified
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: Draize and Kelley (Drug Cosmet. Industr. 71 (1952) 36)
- Deviations:
- not specified
- GLP compliance:
- no
- Remarks:
- 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
- Physical state: Clear colourless liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 100%
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 6 animals
- Details on study design:
- Protocol for eye irritation test
In general the techniques of tests as published by the FDA of the United. States (Fed. Reg. 28 (119), 5582, 1963) and. Draize and Kelley (Drug Cosmet. Industr. 71 (1952) 36) are followed.
Six New Zealand White albino rabbits are used for each test substance.
The animals are caged individually and receive no hay or other extraneous material that might enter the eyes.
The eyes of the animals are examined before testing and only those animals without observable eye defects are used. One tenth of a millilitre of the test substance, or in the case of solids or semisolids, 100 milligrams of the test substance, is allowed to tell everted lower lid. of one eye of each rabbit; the War and lower eye lid are then carefully closed and subsequently held together for at least one second before releasing, to prevent loss of material. The other eye, remaining untreated, serves as a control.
The eyes are not washed following instillation and the animals are released immediately.
The eyes are examined at 2%, 1&8, 72 hours and 7 days after instillation of the test material.
An animal is considered as giving a positive reaction if there is, at any of the readings, discernible opacity of the cornea (other than a slight dulling of the normal lustre), or ulceration of the cornea, or inflammation of the iris (other than a. slight deepening of the folds (rugse) or a. slight circumcorneal injection), or if such substance produces in the conjunctivae (palpebrel and bulbar, excluding the cornea and iris) an obvious swelling with partial eversion of the lids, or a diffuse deep-crimson red with individual vessels not easily discernible. The FDA-scoring scale was used.
The test is considered positive it four or more of the animals in the test group of six rabbits exhibit a positive reaction. If one animal exhibits a positive reaction, the test is regarded as negative.
If two or three animals exhibit 9, positive reaction, the test is re- pea-ted, using a different group of six animals. The second test is considered as positive if three or more of the animals exhibit a positive reaction. If only one or two animals in the second test exhibit a positive reaction, the test is again repeated with a different group of six animals. Should a third test he needed, the substance will be regarded as an irritant if two or more animals exhibit a positive response.
A substance which has elicited corneal and/or iris lesions which have not cleared by the seventh day reading, is considered a severe eye irritant.
Grades for ocular lesions:
Cornea.
No ulceration or opacity = 0
Scattered or diffuse areas of opacity (other than slight dulling of normal luster), details of iris clearly visible = (1)'
Easily discernible translucent areas, details of iris slightly obscured = 2
Nacreous areas, no details of iris visible, size of pupil barely discernible = 3
Complete corneal opacity, iris not discernible = 4
Iris
Normal = 0
Markedly deepened folds, congestion, swelling, moderate circumcorneal injection (any of these or combination of any thereof), iris still reacting to light (sluggish reaction is positive) = (1)*
No reaction to light, haemorrhage, gross destruction (any or all of these) = 2
Conjunctivae
-Redness (refers to palpebral and bulbar conjunctivae excluding cornea and iris)
Vessels normal = 0
Some vessels definitely injected = 1
Diffuse, crimson red, individual vessels not easily discernible = (2)*
Diffuse beefy red = 3
-Chemosis
No swelling = 0
Any swelling above normal (includes nictitating membrane) 1
Obvious swelling with partial eversion of lids (2)*
Swelling with lids about half closed = 3
Swelling with lids more than half closed = 4
(*Bracket figures indicate lowest grades considered positive.)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- Animal 1
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Based on conjunctival redness
- Irritation parameter:
- conjunctivae score
- Remarks:
- Animal 2
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Based on conjunctival redness
- Irritation parameter:
- conjunctivae score
- Remarks:
- Animal 3
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Based on conjunctival redness
- Irritation parameter:
- conjunctivae score
- Remarks:
- Animal 4
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Based on conjunctival redness
- Irritation parameter:
- conjunctivae score
- Remarks:
- Animal 5
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Based on conjunctival redness
- Irritation parameter:
- conjunctivae score
- Remarks:
- Animal 6
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.66
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Based on conjunctival redness
- Irritation parameter:
- chemosis score
- Remarks:
- Animal 1
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Remarks:
- Animal 2
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Remarks:
- Animal 3
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Remarks:
- Animal 4
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Remarks:
- Animal 5
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
Any other information on results incl. tables
Herboxane caused slight conjunctivitis in 2/6 rabbits and moderate conjunctivitis in 4/6 rabbits. Two animals (no. 3 and 4) showed slight discharge of eye fluid. At the end of the seven—day observation period four animals still showed slight redness of the conjunctivae.
Table Of Individual Scores Awarded To The Ocular Lesions Elicited By Herboxane
Rabbit Number |
Score |
|||
Cornea |
Iris |
Conjunctivae |
||
Redness |
Chemosis |
|||
after 24 hours |
||||
1 |
0 |
0 |
2 |
1 |
2 |
0 |
0 |
1 |
0 |
3 |
0 |
0 |
2 |
1 |
4 |
0 |
0 |
2 |
2 |
5 |
0 |
0 |
1 |
1 |
6 |
0 |
0 |
2 |
1 |
after 48 hours |
||||
1 |
0 |
0 |
1 |
0 |
2 |
0 |
0 |
2 |
1 |
3 |
0 |
0 |
1 |
1 |
4 |
0 |
0 |
2 |
2 |
5 |
0 |
0 |
1 |
0 |
6 |
0 |
0 |
2 |
0 |
after 72 hours |
||||
1 |
0 |
0 |
1 |
0 |
2 |
0 |
0 |
1 |
0 |
3 |
0 |
0 |
1 |
0 |
4 |
0 |
0 |
2 |
1 |
5 |
0 |
0 |
1 |
0 |
6 |
0 |
0 |
1 |
0 |
after 7 days |
||||
1 |
0 |
0 |
1 |
0 |
2 |
0 |
0 |
0 |
0 |
3 |
0 |
0 |
1 |
0 |
4 |
0 |
0 |
1 |
0 |
5 |
0 |
0 |
1 |
0 |
6 |
0 |
0 |
0 |
0 |
On the basis of the present results it is concluded that according to the FDA-standards undiluted Herboxane is considered to be an eye irritant.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- On the basis of the present results it is concluded that according to the FDA-standards undiluted Herboxane is considered to be an eye irritant.
- Executive summary:
The product Herboxane was examined an in-eye irritation test. New Zealand White albino rabbits were used as the experimental animals. According to the FDA-standards, undiluted Herboxane is considered to be an eye irritant.
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