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EC number: 202-680-6 | CAS number: 98-55-5
- 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
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- Endpoint summary
- Stability
- Biodegradation
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- 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://chesar.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:
- key study
- Study period:
- 2006-02-20 to 2006-02-26
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study following OECD TG 405.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
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:
- Terpineol multi: 8000-41-7
- IUPAC Name:
- Terpineol multi: 8000-41-7
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): Dertol 90
- Substance type: multi-constituent
- Physical state: liquid
- Storage condition of test material: 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
- Source: Elevage de Gerome, Linxe, France
- Weight at study initiation: between 2.15 and 2.57 kg
- Housing: individual box installed in conventional air conditioned
-Diet(ad libitum): supplied by UAR, Villemoison s/Orange, France, ad libitum
-Water(ad libitum): tap water from public distribution system, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): between 20 and 22
- Humidity (%): between 30 and 37
-Air changes: at least 10 cycles per hour
-Photoperiod (hours dark / hours light): 12/12
IN-LIFE DATES: From: 2006-02-20 To: 2006-02-26
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- 24 hours, no washing done
- Observation period (in vivo):
- Observations performed at 1, 24, 48 and 72 h up to 21 days
- Number of animals or in vitro replicates:
- 3 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing
SCORING SYSTEM: According to the scale of lesion scores published in Directive n° 2004/73/EC and OECD guideline n°405
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- chemosis(A)
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness (C)
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- iris score
- Remarks:
- lesion (D)
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- cornea opacity score
- Remarks:
- opacity (E)
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- chemosis (A)
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness (C)
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- iris score
- Remarks:
- lesion (D)
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- cornea opacity score
- Remarks:
- opacity (E)
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- chemosis (A)
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness (C)
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- iris score
- Remarks:
- lesion(D)
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- cornea opacity score
- Remarks:
- opacity (E)
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritant / corrosive response data:
- Moderate redness at the conjunctival level associated with moderate chemosis and moderate opacity at the corneal level. All effects were totally reversible within the 7th day at the latest.
Any other information on results incl. tables
Table 1: 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) |
||
A 7230 |
24 hours |
1 |
2 |
0 |
2 |
48 hours |
1 |
2 |
0 |
2 |
|
72 hours |
1 |
2 |
0 |
2 |
|
TOTAL MEAN |
3 |
6 |
0 |
6 |
|
1.0 |
2.0 |
0.0 |
2.0 |
||
A 7231 |
24 hours |
1 |
2 |
0 |
2 |
48 hours |
1 |
2 |
0 |
2 |
|
72 hours |
1 |
1 |
0 |
2 |
|
TOTAL |
3 |
5 |
0 |
6 |
|
MEAN |
1.0 |
1.7 |
0 .0 |
2.0 |
|
A 7232 |
24 hours |
2 |
2 |
0 |
2 |
48 hours |
2 |
1 |
0 |
0 |
|
72 hours |
1 |
1 |
0 |
0 |
|
TOTAL |
5 |
4 |
0 |
2 |
|
MEAN |
1.7 |
1. 3 |
0.0 |
0.7 |
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under test conditions DERTOL 90 is irritant to eyes and should be classified R36 "irritant to eyes" according to the criteria of directive n°67/548/EEC and Category 2 according to CLP regulation (EC) n°1272/2008.
- Executive summary:
In an eye irritation study conducted according to the OECD Guideline 405 and in compliance with GLP, 3 healthy adults female rabbits of the New Zealand White strain were exposed to 0.1 mL of undiluted Terpineol multi in one eye while the other eye corresponded to the control. The eyes were examined unwashed and the changes were observed at 1, 24, 48 and 72 hours after dosing and graded (scale of lesion scores according to Directive n° 2004/73/EC and OECD guideline 405).
The occular reactions observed during the study have been moderate. The individual mean scores for conjunctival chemosis were 1.0, 1.0 and 1.7, conjunctival redness scores were 2.0, 1.7 and 1.3, cornea opacity scores were 2.0, 2.0 and 0.7 and iris lesion scores were 0.0 for all animals.
At the conjuctivae level, a moderate redness, noted 24 h after the test item installation and totally reversible between the 6th and 7th day of the test, was associated with a moderate chemosis, noted 1h after the test item instillation and totally reversible between the 5th and 6th day of the test. At corneal level, moderate opacity was observed 24 h after the test substance administration and totally reversible between the 3rd and 6th day.
Under these test conditions,Terpineol multi is considered as irritating to eyes according to the criteria of directive 67/548/EEC and CLP regulation (EC) n°1272/2008.
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.
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