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EC number: 830-217-3 | CAS number: 1393932-71-2
- 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:
- From 31 Jan, 1994 to 14 Feb, 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-({2,2-bis[(prop-2-enoyloxy)methyl]butoxy}methyl)-2-[(prop-2-enoyloxy)methyl]butyl prop-2-enoate
- EC Number:
- 830-217-3
- Cas Number:
- 1393932-71-2
- Molecular formula:
- Not applicable for this UVCB
- IUPAC Name:
- 2-({2,2-bis[(prop-2-enoyloxy)methyl]butoxy}methyl)-2-[(prop-2-enoyloxy)methyl]butyl prop-2-enoate
- 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:
- TEST ANIMALS
- Source: Three healthy adult rabbits of the New Zealand White strain were obtained from Froxfield (U .K.) Ltd., Petersfield, Hampshire, England.
- Age at study initiation: 12 to 15 weeks
- Weight at study initiation: 2.8 to 3.4 kg
- Housing: Housed individually in plasticcages with perforated floors in buliding R 14 room 1
- Diet: Ad libitum, satndard laboratory diet SDS stanrab (P) rabbit diet (diet was not analysed for nutrients, contaminants or micro-organisms)
- Water: Ad libitum, routine chemical examination of drinking water at source was conducted usually weekly by the supplier
- Acclimation period: Yes
ENVIRONMENTAL CONDITIONS
- Temperature: 19°C
- Humidity: 30 to 70%
- Air changes (per hr): 19 changes/h
- Photoperiod (hrs dark / hrs light): 12 h of artificial light (0700 - 1900 h) in each 24 h period.
Each animal was identified by a numbered aluminium tag placed through the edge of one ear.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1 mL undiluted
- Duration of treatment / exposure:
- Single instillation
- Observation period (in vivo):
- Observations were made 1, 24, 48 and 72 h after exposure.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- -Treatment: The eyes of each animal was examined prior to instillation of the test substance to ensure that there is no pre-existing corneal damage, iridial or conjunctival inflammation.
- One animal was tested in advance to ensure that if a severe response was produced no further animals would be exposed.
- Single instillation of 0.1 mL undiluted test substance was made in the lower everted lid of one eye of each animal. The lids were then gently held together for about 1 sec to prevent loss of the test substance. The contralateral eye remained untreated.
-Observation:
Clinical signs: Once daily.
Ocular responses: The eyes of each animal were examined approx 1, 24, 48 and 72 h and after 4 and 7 d after instillation of the test substance. The irritation scores and a description of all other (local) effects were recorded. Observations 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 #1
- Time point:
- 24/48/72 h
- Score:
- ca. 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0.66
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 2.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 1.63
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- Irritant / corrosive response data:
- Irritation: Instillation of approx 0.1 mL undiluted test substance into one eye of each of three rabbits resulted in corneal opacities, transient iridial inflammation, a diffuse crimson or beefy red coloration of the conjunctivae accompanied by swelling with partial eversion of the eyelids or with the eyelids closed. The eyes became normal 7 d after instillation.
- Other effects:
- No signs of toxicity or ill health were observed in any rabbit during the observation period.
Any other information on results incl. tables
Results:
Rabbit number |
Region of eye |
1 h |
24 h |
48 h |
72 h |
4 d |
7 d |
27 (male) |
Cornea |
dulling |
1 |
1 |
1 |
1 |
0 |
Iris |
0 |
1 |
0 |
0 |
0 |
0 |
|
Conjunctivae (redness) |
2 |
3 |
2 |
1 |
1 |
0 |
|
Conjunctivae (chemosis) |
2 |
3 |
2 |
1 |
0 |
0 |
|
81 (female) |
Cornea |
0 |
1 |
1 |
1 |
1 |
0 |
Iris |
0 |
1 |
1 |
0 |
0 |
0 |
|
Conjunctivae (redness) |
2 |
2 |
3 |
2 |
2 |
0 |
|
Conjunctivae (chemosis) |
2 |
2 |
2 |
1 |
1 |
0 |
|
82 (female) |
Cornea |
0 |
0 |
1 |
1 |
1 |
0 |
Iris |
0 |
0 |
0 |
1 |
0 |
0 |
|
Conjunctivae (redness) |
2 |
2 |
2 |
2 |
2 |
0 |
|
Conjunctivae (chemosis) |
2 |
1 |
1 |
1 |
1 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- other: Category 2 (irritating to eyes) based on CLP criteria
- Conclusions:
- Under the test conditions, undiluted di-TMPTTA was found to be irritating to the eye of rabbit under CLP (EC 1272/2008) but not under EC (67/548/EEC) criteria.
- Executive summary:
A study was performed to assess the eye irritation potential of di-TMPTTA in New Zealand White rabbits according to OECD Guideline 405 and EU Method B.5, in compliance with GLP. 0.1 mL undiluted test substance was placed in the lower everted lid of one eye of each of three animals. The lids were then gently held together for about 1 s to prevent loss of the test substance. The contralateral eye remained untreated and served as a negative control. Instillation resulted in corneal opacities, transient iridial inflammation, and diffuse crimson or beefy red coloration of the conjunctivae accompanied by swelling with partial eversion of the eyelids or with the eyelids closed. The eyes returned to normal 7 d after instillation. Given a conjunctival redness score ≥ 2 but ≤ 2.5 in 2 out of 3 animals, calculated as the mean score following grading at 24, 48 and 72 h and reversible within 21 days, the test substance was considered to be irritating to the eyes of rabbits under CLP (EC 1272/2008) but not under EC (67/548/EEC) criteria (Parcell 1994).
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