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EC number: 275-912-7 | CAS number: 71720-84-8
- 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:
- March from 09 to 20, 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted May 12, 1981
- GLP compliance:
- no
Test material
- Reference substance name:
- Acid Green 040
- IUPAC Name:
- Acid Green 040
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG CH 4414 FueIllinsdorf/SwitzerIand.
- Age at study initiation: 14 - 15 weeks.
- Weight at study initiation: 2.4 - 2.8 kg.
- Housing: individually in stainless steel cages equipped with an automatic cleaning and drinking system.
- Diet: pelleted standard KIiba 341, Batch 94/84 rabbit maintenance diet, ad Iibitum.
- Water: community tap water from Itingen, ad libitum.
- Acclimation period: 4 days under laboratory conditions after veterinary examination.
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 2 °C
- Relative humidity: 55 ± 10 %
- Air changes: 10 - 15 air change per hour.
- Photoperiod: 12 hours artificial fluorescent light/12 hours dark.
- Other: at least 8 hours music/light period.
Test system
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- A single dose was administered to the left eye of each animal, individual dose volume was 0.1 g per animal.
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 2 males and 1 female
- Details on study design:
- TOOL USED TO ASSESS SCORE: eye examinations were made with a slit-lamp 30 SL.
OBSERVATIONS
- Viability / Mortality: daily.
- Body weights: pre-test, day 1 and at termination.
SCORING SYSTEM
The eyes of each animal were examined 1, 24, 48, 72 hours and 7 days after administration.
The irritation was assessed according to the OECD guideline 405 "Acute Eye Irritation/Corrosion " adopted May 12, 1981.
The corrosive properties of the test article and the color of the treated eye were described and recorded.
The following subjective numerical scoring system was used to grade the eye lesions.
CORNEAL IRRITATION
Opacity, degree of density (densest area used for assessment)
No ulceration of opacity 0
Scattered or diffuse areas of opacity (other than slight dulling of normal lustre), details of iris clearly visible 1
Easily discernible translucent area, details of iris slightly obscured 2
Nacreous area for details of iris visible, size of pupil banely discernible 3
Opaque cornea, iris not discernible through the opacity 4
IRIDIC IRRITATION
Normal 0
Markedly deepened rugae, congestion, swelling, moderate circurncorneal hyperemia, or injection, any of these or combination thereof, iris still reacting to light (sluggish reaction is positive) 1
No reaction to light, hemorrahge, gross destruction (any or all of these) 2
CONJUNCTIVAL IRRITATION
Redness (refers to palpebrar and bulbar conjunctivae, cornea and iris)
Blood vessels normal 0
Some blood vessels definitely hyperaemic (injected) 1
Diffuse, crimson color, individual vessels not easily discernible 2
Diffuse beefy red 3
Chemosis, lids and/or nictating membranes
No swelling 0
Any swelling above normal (include nictating membranes) 1
Obvious swelling with partial eversion of lids 2
Swelling with lids about half closed 3
Swelling with lids more than half closed 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 3/3
- Time point:
- 24/48/72 h
- Score:
- >= 1 - <= 1.7
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal: 3/3
- Time point:
- 24/48/72 h
- Score:
- < 1
- Reversibility:
- fully reversible within: 48 hrs
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 3/3
- Time point:
- 24/48/72 h
- Score:
- >= 2.3 - <= 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal: 3/3
- Time point:
- 24/48/72 h
- Score:
- < 2
- Reversibility:
- fully reversible within: 72 hrs
- Irritant / corrosive response data:
- Test item showed a primary irritation score of 5.0 when applied to the rabbit eye mucosa.
In the area of application a bluish discoloration of the cornea and conjunctivae was observed within 1 hour after treatment. This could be related to effects of the test article.
No corrosion of the cornea was observed at each of the measuring intervals. - Other effects:
- TOXIC SYMPTONS / MORTALITY
No acute toxic symptoms were observed in the animals during the test period, and no mortality occurred.
BODY WEIGHT
The body weight gain of all rabbits was similar.
Any other information on results incl. tables
MEAN SCORES PER ANIMAL
Animal N. / sex | Reaction | 1 hr | 24 hrs | 48 hrs | 72 hrs | 7 days | Mean 24/48/72 hrs |
323 M | Corneal opacity | 1* | 1* | 1* | 1* | 0 | 1.00 |
324 M | Corneal opacity | 2* | 2* | 1* | 1* | 0 | 1.33 |
325 F | Corneal opacity | 1* | 2* | 2* | 1* | 0 | 1.66 |
323 M | Iris | 0 | 1* | 0 | 0 | 0 | 0.33 |
324 M | Iris | 0 | 1* | 0 | 0 | 0 | 0.33 |
325 F | Iris | 0 | 1* | 0 | 0 | 0 | 0.33 |
323 M | Conjunctival redness | 1 | 3* | 3* | 3* | 1 | 3.00 |
324 M | Conjunctival redness | 1 | 3* | 3* | 2* | 0 | 2.67 |
325 F | Conjunctival redness | 1 | 3* | 2* | 2* | 0 | 2.33 |
323 M | Conjunctival chemosis | 2* | 2* | 1 | 0 | 0 | 1.00 |
324 M | Conjunctival chemosis | 3* | 1 | 1 | 0 | 0 | 0.67 |
325 F | Conjunctival chemosis | 2* | 1 | 1 | 0 | 0 | 0.67 |
INDIVIDUAL FINDINGS
Animal No 323, male
After 1 hr | Cornea: opacity, slight, whole; discolored. Conjunctivae: reddened, slight, dorsal; edema, clear visible; discolored, including nictating membrane, substance remainders, greenish mucous diffuse. Sclera: not visible. Discharge: severe. |
After 24 hrs | Cornea: opacity, whole, diffuse. Iris: red. Conjunctivae: reddened severe; edema. Sclera: reddened, severe. Discharge: moderate to severe. |
After 48 hrs | Cornea: opacity ventral. Conjunctivae: reddened severe; edema slight. Sclera: reddened, severe. Discharge: minimal |
After 72 hrs | Cornea: opacity ventral, diffuse, hardly visible. Conjunctivae: reddened severe. Sclera: reddened, severe. |
After 7 days | Conjunctivae: reddened, conjunctival sac, hardly visible. |
Animal No 324, male
After 1 hr | Iris: darkened. Conjunctivae: reddened, slight; edema, severe, discolored including nictating membrane; substance remainders, greenish mucous, diffuse. Sclera: not visible. Discharge: severe. |
After 24 hrs | Cornea: opacity, whole. Iris: red. Conjunctivae: reddened, severe, whole; edema, slight. Sclera: reddened, severe. Discharge: severe. |
After 48 hrs | Cornea: opacity, whole. Conjunctivae: reddened, severe, whole; edema, slight. Sclera: reddened, severe. |
After 72 hrs | Cornea: opacity, whole. Conjunctivae: reddened, clear visible. Sclera: reddened, ventral |
After 7 days | No abnormal changes visible. |
AnimaI No 325, female
After 1 hr | Cornea: opacity, slight, whole; discolored. Conjunctivae: reddened, slight, dorsal; edema, clear visible; discolored, including nictating mernbrane, substance remainders, greenish rnucous, diffuse. Sclera: not visible. Discharge: severe. |
After 24 hrs | Cornea: opacity, whole. Iris: red, slight. Conjunctivae: reddened, severe; edema, slight. Sclera: reddened, slight. Discharge: moderate. |
After 48 hrs | Cornea: opacity, diffuse. Conjunctivae: reddened, clear visible; edema slight. Sclera: reddened, clear visible. Discharge: minimal. |
After 72 hrs | Cornea: opacity, ventral slight. Conjunctivae: reddened, clear visible. Sclera: reddened, clear visible. Discharge: moderate. |
After 7 days | No abnormal changes visible. |
Applicant's summary and conclusion
- Interpretation of results:
- other: Eye Irrit. 2 (H319), according to the CLP Regulation No (EC) 1272/2008
- Conclusions:
- Test item is able to cause eye irritation.
- Executive summary:
The primary eye irritation study was investigate according to the OECD guideline 405. The irritation potential was assessed placing the test item in the conjunctival sac of rabbit eyes. In the area of application a greenish discoloration of the cornea and conjunctivae was observed within 1 hour after treatment. This could be related to effects of the test article. The mean values from gradings at 24, 48 and 72 hours were between 1 and 1.7 for corneal opacity, lower than 1 for iritis, between 2.3 and 3 for conjunctival redness and lower than 2 for conjunctival oedema, in all of the tested animals. No corrosion was observed at each of the measuring intervals.
The substance was found to cause a primary irritation score of 5.0 when applied to the rabbit eye mucosa.
Conclusion
The mean values from gradings at 24, 48 and 72 hours were between 1 - 1.7 for corneal opacity, lower than 1 for iritis, between 2.3 - 3 for both conjunctival redness and lower than 2 for conjunctival oedema, in all of the tested animals. All the reactions were fully recovered within 7 days.
The test item meets the criteria to be classified as capable to causes serious eye irritation (i.e. Eye Irrit. 2, H319), according to the CLP Regulation No (EC 1272/2008).
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