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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: - | 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
![](https://poisoncentres.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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 13. September 2010 - 28. September 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Study under GLP, according to international guidelines and with full documentation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2-propanol and 2-butanol production, distn. residues, sample 2010
- Molecular formula:
- UVCB substance
- IUPAC Name:
- 2-propanol and 2-butanol production, distn. residues, sample 2010
- Test material form:
- liquid
- Details on test material:
- - The analysis was performed for the reference sample "Sample 2010" as defined in Section 1.4
- Lot/batch No.: 10013593
- Expiration date of the lot/batch: March 2011
- Storage condition of test material: For several days, the test item was stored in the test facility at room temperature protected from light and kept under inert gas. As soon as a fridge with explosion prevention was available, the test item was stored at 2 – 8 °C. No relevant changes in composition were detected before and after storage at room temperature (GC chromatograms).
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Elevage de Gérome (Quartier Labaste –F40260 Linxe)
- Age at study initiation: 11 or 15 weeks old
- Weight at study initiation: between 1.93 kg and 3.53 kg
- Housing: individual box
- Diet (e.g. ad libitum), Water (e.g. ad libitum): Drinking water (tap-water from public distribution system) and foodstuff (SDS - C15) were supplied freely.
- Acclimation period: a minimal 5-day acclimatisation period
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23 °C
- Humidity (%): 30 to 70%
- Air changes (per hr): approximately fifteen changes per hour
- Photoperiod (hrs dark / hrs light): twelve hours continuous light (07.00 to 19.00) and twelve hours darkness
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- amount: 0.1 mL
- Observation period (in vivo):
- Ocular examinations were performed on both right and left eyes 1 hour, 24, 48 and 72 hours following treatment.
NOTE: As persistent reactions were noted at 72 hours post-dose, additional observations have been carried out from day 4 daily for up to 9 days in order to determine the reversible character of the lesions observed. - Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- Eye examinations were carried out using the scale of lesion scores according to OECD 405.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: between days 7 and 9
- Remarks on result:
- other: a moderate redness noted 1 hour after the test item instillation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.8
- Max. score:
- 4
- Reversibility:
- fully reversible within: between days 7 and 8
- Remarks on result:
- other: a moderate to important chemosis noted 1 hour after the test item instillation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible within: one day
- Remarks on result:
- other: a congestion, noted 1 hour after the test item instillation in two animals
- Irritation parameter:
- cornea opacity score
- Remarks:
- opacity
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Remarks on result:
- other: a moderate corneal opacity
Any other information on results incl. tables
INDIVIDUAL AND MEAN SCORES OF CONJUNCTIVAE, IRIS AND CORNEA
Animal n° | Time after treatment | Conjunctivae | Iris | Cornea | |
Chemosis (A) | Redness (C ) | Lesion (D) | Opacity (E ) | ||
A0356 | 24 hours | 2 | 2 | 0 | 2 |
48 hours | 1 | 2 | 0 | 0 | |
72 hours | 1 | 2 | 0 | 0 | |
Total | 4 | 6 | 0 | 2 | |
Mean | 1.3 | 2 | 0 | 0.7 | |
A0374 | 24 hours | 2 | 2 | 0 | 2 |
48 hours | 2 | 2 | 0 | 0 | |
72 hours | 2 | 1 | 0 | 0 | |
Total | 6 | 5 | 0 | 2 | |
Mean | 2 | 1.7 | 0 | 0.7 | |
A0375 | 24 hours | 2 | 3 | 0 | 2 |
48 hours | 2 | 2 | 0 | 0 | |
72 hours | 2 | 2 | 0 | 0 | |
Total | 6 | 7 | 0 | 2 | |
Mean | 2 | 2.3 | 0 | 0.7 | |
Classificationin accordance with the European regulation | According to the calculated means, the test item has to be classified R36 "irritating to eyes". | ||||
Classificationin accordance with the GHS regulation | According to the calculated means, the test item has to be classified in category 2 "irritating to eyes" with the hazard statement H319 "causes serious eye irritation". |
TOTAL AND INDIVIDUAL SCORES OF OCULAR IRRITATION
Animal No: A0356
Observation time | Conjunctivae | Iris | Cornea | Individual irritation index | ||||||
A | B | C | (A+B+C)x2 | D | Dx5 | E | F | ExFx5 | ||
X= | Y= | Z= | X+Y+Z= | |||||||
1 hour (D0) | 2 | 3 | 2 | 14 | 1 | 5 | 0 | 0 | 0 | 19 |
24 hours (D1) | 2 | 0 | 2 | 8 | 0 | 0 | 2 | 1 | 10 | 18 |
48 hours (D2) | 1 | 0 | 2 | 6 | 0 | 0 | 0 | 0 | 0 | 6 |
72 hours (D3) | 1 | 0 | 2 | 6 | 0 | 0 | 0 | 0 | 0 | 6 |
Day 4 (D4) | 1 | 0 | 2 | 6 | 0 | 0 | 0 | 0 | 0 | 6 |
Day 5 (D5) | 1 | 0 | 2 | 6 | 0 | 0 | 0 | 0 | 0 | 6 |
Day 6 (D6) | 1 | 0 | 2 | 6 | 0 | 0 | 0 | 0 | 0 | 6 |
Day 7 (D7) | 0 | 0 | 2 | 4 | 0 | 0 | 0 | 0 | 0 | 4 |
Day 8 (D8) | 0 | 0 | 1 | 2 | 0 | 0 | 0 | 0 | 0 | 2 |
Day 9 (D9) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Animal No: A0374
Observation time | Conjunctivae | Iris | Cornea | Individual irritation index | ||||||
A | B | C | (A+B+C)x2 | D | Dx5 | E | F | ExFx5 | ||
X= | Y= | Z= | X+Y+Z= | |||||||
1 hour (D0) | 3 | 3 | 2 | 16 | 1 | 5 | 0 | 0 | 0 | 21 |
24 hours (D1) | 2 | 0 | 2 | 8 | 0 | 0 | 2 | 1 | 10 | 18 |
48 hours (D2) | 2 | 0 | 2 | 8 | 0 | 0 | 0 | 0 | 0 | 8 |
72 hours (D3) | 2 | 0 | 1 | 6 | 0 | 0 | 0 | 0 | 0 | 6 |
Day 4 (D4) | 1 | 0 | 1 | 4 | 0 | 0 | 0 | 0 | 0 | 4 |
Day 7 (D7) | 1 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 2 |
Day 8 (D8) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Animal No: A0375
Observation time | Conjunctivae | Iris | Cornea | Individual irritation index | ||||||
A | B | C | (A+B+C)x2 | D | Dx5 | E | F | ExFx5 | ||
X= | Y= | Z= | X+Y+Z= | |||||||
1 hour (D0) | 3 | 3 | 2 | 16 | 0 | 0 | 0 | 0 | 0 | 16 |
24 hours (D1) | 2 | 0 | 3 | 10 | 0 | 0 | 2 | 1 | 10 | 20 |
48 hours (D2) | 2 | 0 | 2 | 8 | 0 | 0 | 0 | 0 | 0 | 8 |
72 hours (D3) | 2 | 0 | 2 | 8 | 0 | 0 | 0 | 0 | 0 | 8 |
Day 4 (D4) | 1 | 0 | 1 | 4 | 0 | 0 | 0 | 0 | 0 | 4 |
Day 7 (D7) | 1 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 2 |
Day 8 (D8) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 2A (irritating to eyes) based on GHS criteria
- Conclusions:
- In conclusion, the results obtained, under these experimental conditions, enable to conclude that the test item „2-propanol and 2-butanol production, distn. residue“ has to be classified in accordance with the Regulation EC No. 1272/2008 on classification, labelling and packaging of substances and mixtures, in category 2 “Irritating to eyes”. The signal word “Warning” and hazard statement H319 “Causes serious eye irritation” are required.
- Executive summary:
Acute eye irritation was assessed for „2-propanol and 2-butanol production, distn. residue“ according to OECD guideline No 405. The test item was instilled as supplied, into the eye of 3 New Zealand rabbits at the dose of 0.1 mL. The experimental protocol was established on the basis of the official method as defined in the OECD guideline No 405 dated April 24th, 2002 and the test method B.5 of the Council regulation No 440/2008. The ocular reactions observed during the study have been moderate to important and totally reversible in the three animals:
- at the conjunctivae level: a moderate redness noted 1 hour after the test item instillation and totally reversible between days 7 and 9, associated with a moderate to important chemosis noted 1 hour after the test item instillation and totally reversible between days 7 and 8,
- at the iris level: a congestion, noted 1 hour after the test item instillation in two animals, and totally reversible on day 1.
- at the corneal level: a moderate corneal opacity, noted 24 hours after the test item instillation, and totally reversible on day 2.
In accordance with the Regulation EC No. 1272/2008 on classification, labelling and packaging of substances and mixtures, the test item has to be classified in category 2 “Irritating to eyes”. The signal word “Warning” and hazard statement H319 “Causes serious eye irritation” are required.
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.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)