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EC number: 201-071-2 | CAS number: 77-94-1
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- 2000-05-09 - 2000-06-06
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP-study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- (1992-07-17)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- (1992-12-29)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Version / remarks:
- (August 1998)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EEC Directive 92/69/EEC (31 July 1992), Annex V, Test B 5 (dated 29 December 1992) and EEC Directive 93/21/EEC, 27 April 1993
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Gefahrstoff-Verordnung (GefStoffV) of 29 September 1994 (BGBL 1, p. 2557)
- Deviations:
- no
- Principles of method if other than guideline:
- None
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Tris(2-ethylhexyl) 2-(acetyloxy)propane-1,2,3-tricarboxylate
- EC Number:
- 205-617-0
- EC Name:
- Tris(2-ethylhexyl) 2-(acetyloxy)propane-1,2,3-tricarboxylate
- Cas Number:
- 144-15-0
- Molecular formula:
- C32H58O8
- IUPAC Name:
- tris(2-ethylhexyl) 2-acetoxypropane-1,2,3-tricarboxylate
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): ATEHC, CAS-NO: 144-15-0
- Physical state: liquid
- Expiration date of the lot/batch: 1 November 2000
- Storage condition of test material: at room temperature
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 3.31, 3.59 and 5.22 kg
- Housing: Before the animals arrived, the study room and cages were cleaned and disinfected. During the study, the room and cages were cleaned at regular intervals. The rabbits were kept individually in a battery of cages with a cage size of 50 x 45 x 40 cm (L x B x H), equipped with a paper disposal system.
- Diet (e.g. ad libitum): Pelleted breeding diet, offered ad libitum.
- Water (e.g. ad libitum): Tap water as for human consumption was continuously available ad libitum via drinking nipples.
- Acclimation period: more than 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Humidity (%): between 30 and 70 %
- Air changes (per hr): 16 times per hour and filtered adequately
- Photoperiod (hrs dark / hrs light): Artificial light was set to give a cycle of 12 hours light and 12 hours dark with light on at 7.00 a.m.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye served as the control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL of the test substance - Duration of treatment / exposure:
- no information given
- Observation period (in vivo):
- up to 72h after the end of exposure
- Number of animals or in vitro replicates:
- 3 animals: 1 female, 2 male
- Details on study design:
- The liquid test substance was used undiluted. One of the animals (rabbit no. 1) was treated in advance in order to assess ocular reactions to the test substance. The animal was treated with 0.1 mL of the test item, which was introduced into the conjunctival sac of the left eye after gently pulling the lower lid away from the eyeball. The lid was then gently held together for about 1 sec in order to limit loss of the test item. The untreated right eye served as control.
Since there was no remarkable response to the instillation of the test substance, the further two animals were treated subsequently in the same manner.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #2 and #3
- Time point:
- other: 1h, 24h, 48h and 72h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2 and #3
- Time point:
- other: 1h, 24h, 48h and 72h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Time point:
- other: 1h, 24h and 48h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Time point:
- other: 72h
- Score:
- 0
- Max. score:
- 1
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal: #2 and #3
- Time point:
- other: 1h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal: #2 and #3
- Time point:
- other: 24h, 48h and 72h
- Score:
- 0
- Max. score:
- 1
- Irritation parameter:
- conjunctivae score
- Remarks:
- chemosis
- Basis:
- animal: #1, #2 and #3
- Time point:
- other: 1h, 24h, 48h and 72h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- The mean grades of ocular reactions at 24, 48 and 72 h after instillation were lower than the value classified as irritant by the EEC Directive 93/21/EEC of 27 April 1993 and the Gefahrstoffverordnung (GefStoffV) of 29 September 1994 (BGB1. I, p. 2557). When administered to the eye, the test substance may be classified as "non-irritant".
- Other effects:
- Clinical Observations: Slight redness of the conjunctivae and slight discharge were observed in all animals 1 h after instillation. Slight redness was still apparent up to 48 h after instillation in one animal.
No other toxic effects than slight ocular irritation were observed.
Any other information on results incl. tables
Grades for ocular lesions (as stipulated by OECD 405)
Cornea | Grade |
Opacity: degree of density (area most dense taken for reading) | |
No ulceration or 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, no details of iris visible, size of pupil barely discernible | 3 |
Opaque cornea, iris not discernible through the opacity | 4 |
Iris | Grade |
Normal | 0 |
Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia or 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 | Grade |
Redness (refers to palpebral and bulbar conjunctivae, cornea and iris) | |
Blood vessels normal | 0 |
Some blood vessels definitely hyperaemic (injected) | 1 |
Diffuse, crimson colour, individual vessels not easily discernible | 2 |
Diffuse, beefy red | 3 |
Chemosis: lids and/or nictitating membranes | Grade |
No swelling | 0 |
Any swelling above normal (including nictitating 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 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: EU-GHS
- Conclusions:
- The test substance can be regarded as non irritant according to the results of the study.
- Executive summary:
The potential toxicity of acetyltri-2 -ethylhexylcitrate (ATEHC) was assessed in an acute eye irritation/corrosion test on 3 albino rabbits according to OECD 405 and EU method B.5 in compliance with GLP (2000). In each animal, 0.1 mL of the test substance was introduced into the conjunctival sac of the left eye, the untreated right eye served as control. Both eyes were examined at 1, 24, 48 and 72 h post applicationem. The following results were obtained: Slight redness of the conjunctivae and slight discharge were observed in all animals 1 h after instillation. Slight redness was still apparent up to 48 h after instillation in one animal. The observed findings were fully reversible within 72 h p.a. - no other toxic effects than slight ocular irritation were observed.
It can be assumed that the same applies to tributyl citrate (CAS 77-94-1) as it is a near analogue to the test substance acetyltri-2 -ethylhexylcitrate' (ATEHC).
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.
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