Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 700-136-7 | 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- January 19 to 29, 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well documented and reported study, conducted according to internationally accepted technical guidelines and in compliance with GLP in recognized contract research organization.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- of 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- of 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Version / remarks:
- of 1998
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), 12 Nousan, Notification No 8147, November 2000, including the most recent partial revisions.
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- - Age at study initiation (treatment day): 9 - 11 weeks.
- Number and Sex: 3 males
- Animal supplier: Harlan France SARL, Gannat, France
- Weight at study initiation( before application): Minimum 1950 g, maximum 2201 g.
- Housing: Individual housing in cages with perforated floor and with shelters.
- Diet (approx. 100 g/day): Commercially available pelleted rabbit diet (K-H from SSNIFF® Spezialdiäten GmbH, Soest, Germany).
- Hay (at least 3 times/week): Supplier: TecniLab-BMO BV, Someren, The Netherlands)
- Water (ad libitum): Tap water
- Acclimation period: At least 5 days before treatment under laboratory conditions.
During health inspection of the animals prior to treatment, special attention was paid to the eyes, which were free from any abnormality.
ENVIRONMENTAL CONDITIONS
Animal housing and environmental conditions were appropriate for eye irritation / corrosion testing in the rabbit: Controlled environment with approximately 15 air changes per hour, 12 hours artificial fluorescent light and 12 hours darkness per day and 21 – 23ºC. The relative humidity during the study period was 41 – 71%.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- Single dose of 100 mg test substance per animal instilled into the conjunctival sac of one eye. The other eye remained untreated and served as a control.
Explanatory Note Regarding Administered Amount of Test Substance:
Each animal was treated with approximately 116 mg (range: 115.7 - 116.4) of the test substance as received by the testing laboratory corresponding to 100 mg of the test substance expressed as water- and minor impurity-free test substance. Dosing was based on water- and minor impurity-free test substance. Therefore, a multiplication factor of 1.16 was applied to calculate the amount of test substance required for administration. This correction resulted in the administration of a larger amount than the 100 mg prescribed by the guidelines. However, since this correction almost exclusively accounts for the water content of the test substance, it was considered that animal welfare was not adversely affected by this. - Duration of treatment / exposure:
- 72 hours, as the eyes were not rinsed with tap-water or physiological saline after treatment.
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- Eyes were evaluated at: 1, 24, 48 and 72 hours after application. Grades attained at 24, 48 and 72 hours after application were included in the mean gradings of ocular lesions used for eye irritation/corrosion classification.
Immediately after the 24-hour observation, a solution of 2% fluorescein (Merck, Darmstadt, Germany) in water (adjusted to pH 7.0) was instilled into both eyes of each animal to quantitatively determine corneal epithelial damage.
Where standard lighting was considered inadequate for observing minor effects, eye examinations were performed using an ophthalmic examination lamp. In cases of equivocal results when comparing the treated and untreated eyes, the illustrated guide from the Consumer Product Safety Commission, Washington, D.C. 20207 was used for additional control purposes.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- over 3 animals and 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks:
- corneal opacity was always grade 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- over 3 animals and 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- not specified
- Remarks:
- Iris score was always grade 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Remarks:
- over 3 animals and 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.55
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Remarks:
- swelling of lids and/or nictitating membranes
- Basis:
- mean
- Remarks:
- over 3 animals and 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.22
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- other: Area of corneal opacity
- Basis:
- mean
- Remarks:
- over 3 animals and 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h. Reversibility referring to slight dulling of the normal lustre of the cornea (grade 0) in two of three animals
- Irritation parameter:
- other: discharge
- Basis:
- mean
- Remarks:
- over 3 animals and 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritant / corrosive response data:
- Ocular lesions of each individual animal are listed in Table 2 under "Remarks on results including tables and figures".
- Other effects:
- No other effects were reported. Mortality, symptoms of systemic toxicity or adverse effects on bodyweight were not evident.
Any other information on results incl. tables
Table 2: OCULAR LESIONS OF EACH ANIMAL
|
|
Cornea |
|
Iris |
|
Conjunctivae |
|
Comments |
|||||||
Animal |
Time after dosing |
|
Opacity (0-4) |
Area (0-4) |
Fluor area (%)2 |
|
(0-2) |
|
Redness (0-3) |
Chemosis (0-4) |
Discharge (0-3) |
|
|||
|
|
|
|
||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|||
11 |
1 hour |
|
0 |
0 |
|
|
0 |
|
1 |
1 |
2 |
|
a b e |
||
|
24 hours |
|
0 |
0 |
0 |
|
0 |
|
1 |
0 |
1 |
|
e |
||
|
48 hours |
|
0 |
0 |
|
|
0 |
|
0 |
0 |
0 |
|
e |
||
|
72 hours |
|
0 |
0 |
|
|
0 |
|
0 |
0 |
0 |
|
e |
||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||
|
|
|
|
|
|
|
|
|
|
|
|
|
|||
2 |
1 hour |
|
0 |
2 |
|
|
0 |
|
1 |
2 |
2 |
|
a b e g |
||
|
24 hours |
|
0 |
0 |
0 |
|
0 |
|
1 |
1 |
1 |
|
e |
||
|
48 hours |
|
0 |
0 |
|
|
0 |
|
1 |
0 |
0 |
|
e |
||
|
72 hours |
|
0 |
0 |
|
|
0 |
|
0 |
0 |
0 |
|
e |
||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||
3 |
1 hour |
|
0 |
1 |
|
|
0 |
|
1 |
2 |
2 |
|
a b e g |
||
|
24 hours |
|
0 |
0 |
0 |
|
0 |
|
1 |
1 |
1 |
|
e |
||
|
48 hours |
|
0 |
0 |
|
|
0 |
|
1 |
0 |
0 |
|
e |
||
|
72 hours |
|
0 |
0 |
|
|
0 |
|
0 |
0 |
0 |
|
e |
||
|
|
|
|
|
|
|
|
|
|
|
|
|
|||
1 Animal
1 was treated one week before Animals 2 and 3.
(Animal identification numbers stated in the original report were
altered to nos. 1, 2 and 3 for convenience)
2 Green staining after fluorescein treatment (percentage of total corneal area)
Comments:
a Yellow/orange staining by the test substance hampered scoring for redness of the upper and/or lower eyelids and third eyelid.
b Remnants of the test substance in the eye.
e Yellow/orange staining of the head and paws by the test substance.
g Slight dulling of the normal lustre of the cornea (grade 0).
Adverse effects on iris and cornea were not evident during the 72 hour observation period, and staining with 2% fluorescein 24 hours after test substance instillation revealed no corneal epithelial damage. Conjunctival redness, chemosis and discharge were seen in all animals. These signs of irritation had completely resolved within 48 hours after test substance administration in animal No. 1 and within 72 hours in the other two animals. Yellow/orange staining of the fur on the head and paws, caused by the test substance, was noted during the observation period in all animals, but this finding was considered to be toxicologically irrelevant.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In the present study, the overall mean eye irritation scores derived from 3 rabbits 24, 48 and 72 hours post test substance instillation were 0.55 for conjunctival redness, 0.22 for chemosis and 0.0 for both corneal opacity and iridal irritation. In view of the absence of relevant effects on iris and cornea and the presence of only minor conjunctival irritation, which was completely reversible within 72 hours post test substance instillation, and according to EU classification rules [DIRECTIVE 67/548/EEC and REGULATION (EC) 1272/2008], the test substance was considered "not irritating to eyes" and not having any labelling requirement regarding eye irritation.
- Executive summary:
the test substance was tested for eye irritation according to OECD Guideline 405 and the corresponding EC, EPA-OPPTS and JMAFF Technical Guidelines in compliance with GLP. Reliability grade 1 was assigned to the study.
Each of three New Zealand White rabbits was treated for 4 hours by instillation of a single dose of 100 mg test substance* into the conjunctival sac of one eye. The other eye remained untreated and served as a control. Eyes were evaluated for ocular lesions at 1, 24, 48 and 72 hours after instillation.
Conjunctival redness grade 1, chemosis grades 1 or 2 and discharge grade 2 were seen in all animals at 1 hour after test substance instillation. By 24 hours afterwards grades 0 or 1 were assigned to these signs of irritation and by 48 hours they had completely resolved in one animal and by 72 hours in the other two animals. Adverse effects on iris and cornea were not evident throughout the observation period, and staining with 2% fluorescein 24 hours after test substance instillation revealed no corneal epithelial damage. Yellow/orange staining of eyelids and remnants of test substance in the treated eyes were only recorded at 1 hour after test substance instillation and were no longer evident thereafter. Mortality, signs of systemic toxicity or adverse effects on bodyweight were not evident.
In view of the absence of relevant effects on iris and cornea and the presence of only minor conjunctival irritation completely reversible within 72 hours post test substance instillation in the present study, and according to EU classification rules [DIRECTIVE 67/548/EEC and REGULATION (EC) 1272/2008], the test substance was considered "not irritating to eyes" and not having any labelling requirement regarding eye irritation.
________________________________________________________________
* Expressed as water- and minor impurity-free test substance
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.