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EC number: 416-210-4 | CAS number: 128119-70-0
- 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:
- Between 15 March and 05 April 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- -
- EC Number:
- 416-210-4
- EC Name:
- -
- Cas Number:
- 128119-70-0
- Molecular formula:
- C14H26O2
- IUPAC Name:
- 2-methyl-3-({1,7,7-trimethylbicyclo[2.2.1]heptan-2-yl}oxy)propan-1-ol
- Test material form:
- liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Three healthy adult rabbits of the New Zealand White strain were obtained from Froxfield (U.K.) Ltd., Petersfield, Hampshire, England.
The animals were in the weight range of 3.6 to 3.9 kg and approximately 15 weeks of age, prior to treatment (Day 1). All rabbits were acclimatised to the experimental environment.
The rabbits were selected without conscious bias for the study. They were housed individually in plastic cages with perforated floors in Building R 14 Room 1.
A standard laboratory diet SDS Stanrab (P) Rabbit Diet and drinking water were provided ad libitum.
The batch of diet used for the study was not analysed for nutrients, contaminants or microorganisms.
Results of routine chemical examination of drinking water at source as conducted usually weekly by the supplier, are made available to Huntingdon Research Centre Ltd. as quarterly summaries.
Animal room temperature was maintained at approximately 19 QC and relative humidity at 30 - 70 %. These environmental parameters were recorded daily. Air exchange was maintained at approximately 19 air changes per hour and lighting was controlled by means of a time switch to give 12 hours of artificial light (0700 - 1900 hours) in each 24 hours period.
Each animal was identified by a numbered aluminium tag placed through the edge of one ear.
This number was unique within the HRC Industrial Toxicology Department throughout the duration of the study. Each cage, was identified by a coloured label displaying the study schedule number, animal number and initials of the Study Director and Home Office licensee.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- A 0.1 ml amount of the test substance was placed into the lower everted lid of one eye of each animal.
- Observation period (in vivo):
- Up to 21 days
- Number of animals or in vitro replicates:
- 3 (One animal was treated in advance of the others, to ensure that if a severe response was produced no further animals would be exposed)
- Details on study design:
- TREATMENT PROCEDURE
The eyes of each animal were examined prior to instillation of the test substance to ensure that there was no pre-existing corneal damage, iridial or conjunctival inflammation. One animal was treated in advance of the others, to ensure that if a severe response was produced no further animals would be exposed. A 0.1 ml amount of the test substance was placed into the lower everted lid of one eye of each animal. The eyelids were then gently held together for one second before releasing. The contralateral eye remained untreated.
OBSERVATIONS
- Clinical signs: All animals were observed daily for signs of ill health or toxicity.
- Ocular responses: Examination of the eyes was made after 1 hour and 1, 2, 3 (equivalent to 24, 48 and 72 hours after instillation), 4, 7, 14 and 21 days after instillation. Observation of the eyes was aided by the use of a handheld light.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 1606
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 d
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 1607 and 1608
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- iris score
- Basis:
- animal: 1606 and 1607
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- iris score
- Basis:
- animal: 1608
- Time point:
- 24/48/72 h
- Score:
- 0.667
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 1606
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 1607
- Time point:
- 24/48/72 h
- Score:
- 2.333
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 1608
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- chemosis score
- Basis:
- animal: 1606
- Time point:
- 24/48/72 h
- Score:
- 1.333
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 d
- Irritation parameter:
- chemosis score
- Basis:
- animal: 1607
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- chemosis score
- Basis:
- animal: 1608
- Time point:
- 24/48/72 h
- Score:
- 1.333
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- Irritant / corrosive response data:
- - Corneal opacification developed in all three animals together with stripping of the corneal surface.
- Vascularisation of the sclera was seen four days after instillation in one animal (1607 male).
- Iridial inflammation was seen in all three animals.
- A diffuse crimson or beefy red colouration of the conjunctivae, accompanied by obvious swelling with partial eversion of the eyelids was observed in all three animals.
- The eyes were normal 7, 14 or 21 days after instillation. - Other effects:
- CLINICAL SIGNS
There were no signs of toxicity or ill health in any rabbit during the observation period.
Any other information on results incl. tables
Table 1 Ocular Reactions observed after instillation of Bornafix
Rabbit no. and sex |
Region of eye |
One hour |
Day after instillation |
|||||||
1 |
2 |
3 |
4 |
7 |
14 |
21 |
||||
1606 male* |
Cornea |
a1 |
a2 |
a2 |
a2 |
a2 |
1 |
1 |
0 |
|
Iris |
0 |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
||
Conjunctiva |
Redness |
2 |
2 |
2 |
2 |
2 |
1 |
1 |
0 |
|
Chemosis |
1 |
2 |
1 |
1 |
0 |
0 |
0 |
0 |
||
1607 male |
Cornea |
aD |
1 |
1 |
1 |
b1 |
0 |
0 |
|
|
Iris |
0 |
1 |
1 |
1 |
1 |
0 |
0 |
|
||
Conjunctiva |
Redness |
2 |
2 |
2 |
3 |
2 |
2 |
0 |
|
|
Chemosis |
1 |
2 |
2 |
2 |
2 |
0 |
0 |
|
||
1608 male |
Cornea |
aD |
1 |
1 |
1 |
1 |
0 |
|
|
|
Iris |
0 |
1 |
1 |
0 |
0 |
0 |
|
|
||
Conjunctiva |
Redness |
2 |
2 |
2 |
2 |
2 |
0 |
|
|
|
Chemosis |
1 |
2 |
1 |
1 |
1 |
0 |
|
|
* Pilot animal
a Stripping of epithelial cells
b Vascularisation of the sclera
D Dulling of the normal lustre of the cornea
Applicant's summary and conclusion
- Interpretation of results:
- other: The substance is an eye irritant Cat 2 according to EU CLP (1272/2008 and its amendments)
- Conclusions:
- The substance is considered to be irritating to eyes Category 2
- Executive summary:
A study according to OECD 405 was performed to assess the eye irritation potential of Bornafix to the rabbit. Three rabbits were each administered a single ocular dose of 0.1 ml of the test substance and observed for a maximum of 21 days after instillation. A single instillation of Bornafix into the eye of the rabbit elicited corneal opacification, iridial inflammation and well-defined to moderate conjunctival reactions. All reactions had resolved 7, 14 or 21 days after instillation. It is concluded that Bornafix is irritant to the rabbit eye.
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