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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 219-330-3 | CAS number: 2416-94-6
- 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
Endpoint summary
Administrative data
Description of key information
2,3,6-Trimethylphenol is severely irritating to the eye based on the finding of staphyloma and on the severity / irreversibility of observations.
2,3,6-trimethylphenol is a dermal
irritant based on signs of irritation observed in 1/2 animals after
short-term exposure and on necrosis observed after 20-hour exposure. The
signs of irritation / necrosis partially persisted at the end of the
8-day observation period. (Note: the exposure time of 20 hours exceeds
the requirement of OECD TG 404.)
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- no data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well-documented stud report which meets basic scientific principles; pre-GLP study.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- 2 animals, treatment time: 1, 5, 15 min, 20 hours; onservation after 24 hours and 8 days
- Principles of method if other than guideline:
- BASF-Test
- GLP compliance:
- no
- Remarks:
- pre-GLP study
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- light/dark rhythm: 12/12 hours
- Type of coverage:
- semiocclusive
- Preparation of test site:
- not specified
- Vehicle:
- water
- Controls:
- other: untreated sites of the same animals
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): no data
- Concentration (if solution): 50% aqueous suspension
No further data - Duration of treatment / exposure:
- 1 minute, 5 minutes, 15 minutes, 20 hours (dorsal skin)
20 hours (inner auricle) - Observation period:
- 8 days
- Number of animals:
- 2
- Details on study design:
- TEST SITE
- Area of exposure: back and ear
- % coverage: no data
- Type of wrap if used: no data
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
SCORING SYSTEM:
BASF scores, convertible into Draize scores, readings at 24 hours and 8 days after beginning of application - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 0-8 days
- Score:
- >= 1 - <= 3
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks on result:
- other: necrosis
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 0-8 days
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- see table
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Executive summary:
A 50% aqueous preparation applied for up to 20 hours under semiocclusive conditions was irritating to the skin of rabbits.
Reference
Draize scores (erythema and edema) and findings:
Site |
Exposure time |
24-hour reading |
8-day reading |
||
Animal no. 1 |
Animal no. 2 |
Animal no. 1 |
Animal no. 2 |
||
Back |
1 min |
Erythema: 2 |
No finding |
No finding |
No finding |
5 min |
Erythema: 2 |
No finding |
No finding |
No finding |
|
15 min |
Erythema: 3 |
Erythema: 1 |
Slight desquamation |
No finding |
|
20 h |
Centre: whitish-anemic Surrounding area: Erythema: 2 |
Erythema: 2 Necrotic focus (area ca. 1 cm²) |
Superficial necrosis |
Erythema: 2 Superficial necrosis |
|
Ear |
20 h |
Erythema: 2 Spotted anemic |
Erythema: 2 Superficial necrosis |
Encrustation |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- no data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well-documented study report which meets basic scientific principles; pre-GLP study.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- reading after 1,24hours, 8 days, 2 animals
- Principles of method if other than guideline:
- BASF-Test
- GLP compliance:
- no
- Remarks:
- pre-GLP study
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- dark/light rhythm 12/12 hours
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: talcum
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1 spoon of the kristalline unchanged substance - Duration of treatment / exposure:
- up to 8 days, no substance wash out
- Observation period (in vivo):
- 8 days
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM:
BASF scores, convertible into Draize scores, readings at 24 hours and 8 days after beginning of application
TOOL USED TO ASSESS SCORE: no data - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 0-8 days
- Score:
- >= 1 - <= 3
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks on result:
- other: staphyloma
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 0-8 days
- Score:
- >= 0 - <= 1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 0-8 days
- Score:
- >= 1 - <= 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- other: staphyloma
- Irritant / corrosive response data:
- see table
- Interpretation of results:
- Category 1 (irreversible effects on the eye)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Executive summary:
The test substance caused severe damage to the eyes when instilled unchanged into the conjunctival sac of the eye of the rabbits.
Reference
Draize scores and findings:
Reading |
Animal no |
Treated eye |
Control eye |
|||||
Cornea |
Iris |
Redness |
Edema |
Remarks |
Redness |
Remarks |
||
1 hour |
1 |
1 |
0 |
1 |
3-4 |
- |
2 |
RS |
2 |
1 |
0 |
1 |
2 |
- |
2 |
RS |
|
24 hours |
1 |
3 |
1 |
2 |
2 |
H |
2 |
|
2 |
3 |
1 |
2 |
2 |
- |
0 |
||
8 days |
1 |
3 |
0 |
2 |
0 |
S, IV |
0 |
|
2 |
3 |
0 |
0 |
0 |
IV |
0 |
Legend: abbreviations used for remarks
RS = residues of the test substance
H = hemorrhages
S = staphyloma
IV = ingrowing vessels
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Eye irritation
In a primary eye irritation study (BASF, 1969), 0.05 ml bulk volume of unchanged, solid 2,3,6 -trimethylphenol (purity not given) was instilled into the conjunctival sac of one eye of two rabbits without rinsing. Talcum was placed into the other eye for control purpose. Animals then were observed for 8 days. Irritation was scored by an internal BASF method; the scores of which are convertible to the Draize system. In this study, 2,3,6 -trimethylphenol is severely irritating to the eye based on the finding of staphyloma and on the severity / irreversibility of observations. Instillation of the test substance produced corneal opacity (up to grade 3), iritis (grade 1), conjunctivae redness (up to grade 2), chemosis (up to grade 3 -4), hemorrhages, staphyloma and ingrown vessels. The signs of irritation / lesions partially persisted at the end of the 8 -day observation period. In this study, 2,3,6 -Trimethylphenol is severely irritating to the eye based on the finding of staphyloma and on the severity / irreversibility of observations.
Skin irritation
In a primary dermal irritation study (BASF, 1969), two rabbits were dermally exposed to a 50% aqueous suspension of 2,3,6 -trimethylphenol (purity not given) for 1, 5, and 15 minutes (short-term exposure, application to the back). Additionally, the two rabbits were exposed the same suspension for 20 h (long-term exposure; application to the back and ear). Animals then were observed for 8 days. Irritation was scored by an internal BASF method; the scores of which are convertible to the Draize system. Erythema of grade 2 to 3 was reported after application for 1, 5, or 15 minutes for 1/2 animal. Erythema of grade 2 and necrosis was observed in both animals after application for 20 h; the findings were not reversible within 8 days.
2,3,6 -trimethylphenol (no further data) was irritating to the rabbit skin (HRC, 1985). The study is available as secondary citation only, and therefore not assignable at the moment.
Effects on skin
irritation/corrosion: irritating
Effects on eye irritation: corrosive
Justification for classification or non-classification
The available experimental test data are reliable and suitable for classification purposes under regulation 1272/2008. 2,3,6 -trimethylphenol has to be classified as corrosive / causing severe damage to the eye Cat. 1 (H318) and as irritating to the skin Cat. 2 (H315).
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.