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EC number: 205-745-7 | CAS number: 149-73-5
- 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
- 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
Skin Irritation, rabbit: non-irritating (Huels, Muermann 1992)
Skin Irritation, rabbit: non-irritating (DuPont Haskell, Majkut 1966)
Eye irritation, rabbit: irritant, average scores day 1-3: cornea 0.78, iris 0.45, erythema 2.67, chemosis 1.67, reversible in 20 days (Huels, Muermann 1992)
Eye Irritation, rabbit: irritant, moderate corneal injury, reversible (DuPont Haskell, Reinke 1966)
Respiratory irritation: clear signs of irritation noted in acute inhalation toxicity (cf. 7.2.2)
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:
- 1992-11-09 to 1992-11-23
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- other: Kleine Weisse Russen, strain Chbb:HM, SPF
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Kleine Weisse Russen, strain Chbb:HM, SPF
- Age at study initiation: adult
- Weight at study initiation: 2 - 3 kg
- Housing: conventional, individual animals in stainless steel cages
- Diet: ad libitum, Ssniff K 4 Alleindiaet fuer Kaninchen
- Water: communal drinking water ad libitum
- Acclimation period: > 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12
IN-LIFE DATES: From: 1992-11-09 To: 1992-11-13 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume): 0.5 cm3
- Concentration (if solution): undiluted
VEHICLE
- none - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 30-60 min, 24 h, 48 h, and 72 h after removal of patch
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: approximately 6cm2
- Type of wrap: gauze patch, held in place with non-irritating tape, semi-occlusive dressing
REMOVAL OF TEST SUBSTANCE
- Washing: with warm water
- Time after start of exposure: 4 hours
SCORING SYSTEM: OECD Guideline 404: Table: Grading of skin reactions - Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- all animals had score 0 at all times
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks:
- no erythema or eschar formation at any time
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- all animals had score 0 at all times
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks:
- no edema formation at any time
- Irritant / corrosive response data:
- No signs of dermal irritation were observed 30-60 min after the removal of the patches. Neither were any skin reactions (erythema or edema) found at the later observation time points (24, 48, and 72 hours)
- Other effects:
- none observed
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance does not meet GHS classification criteria for skin irritation.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1966
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Clipped dorsal rabbit skin was wrapped with impervious film (secured by tape). Test substance was introduced through an opening (which was then sealed). Animals immobilized in FDA-type wooden stocks for up to 60 min. or 6 hours, then fitted with collars for 24 hrs to prevent oral uptake. 14-day observation with assessment of skin reactions, necropsy.
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- other: Albino, not otherwise specified
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit):
1) 2250 mg/kg bw (4.6 ml per animal, application site loosely covered)
2) 2250 mg/kg bw (5.9 ml per animal, application site wrapped with occlusive patch)
3) 3400 mg/kg bw (11.2 ml per animal, application site wrapped with occlusive patch)
- Concentration (if solution): 100% undiluted
VEHICLE
-none - Duration of treatment / exposure:
- 1) 55 minutes: 2250 mg/kg bw (application site loosely covered)
2) 1 hour: 2250 mg/kg bw (application site wrapped with occlusive patch)
3) 6 hours: 3400 mg/kg bw (application site wrapped with occlusive patch) - Observation period:
- 14 days
- Number of animals:
- 3 (one per dose and type of coverage)
- Details on study design:
- TEST SITE
- Area of exposure and % coverage: no data
- Type of wrap if used: impervious film, secured at each end with Elastoplast. Opening in the center back to introduce test substance, then closed with strip of adhesive
- 2-inch polyethylene collars to prevent oral uptake during first 24 hours (before washing)
- One experiment with 2250 mg/kg bw performed without occlusive wrap, loosely covered
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water, then dried
- Time after start of exposure: 24 hours
SCORING SYSTEM:
- none; verbal descriptions of findings - Irritation parameter:
- erythema score
- Remarks:
- derived from verbal description of effects
- Basis:
- animal #3
- Remarks:
- 3400 mg/kg bw, 6 hours exposure, occlusive
- Time point:
- other: days 1-5
- Score:
- >= 1 - <= 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Remarks on result:
- other: mild to moderate on day 1, diminishing
- Irritant / corrosive response data:
- No corrosion observed
- Other effects:
- No systemic effects observable
- Interpretation of results:
- slightly irritating
- Remarks:
- Criteria used for interpretation of results: EU
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1966
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Principles of method if other than guideline:
- Simple screening test, right eyes of two animals instilled, one washed after 20 seconds
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- other: Albino, not otherwise specified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): 100% (used as received)
VEHICLE
- none - Duration of treatment / exposure:
- Animal 1: washed 20 seconds after instillation with tap water for 1 minute
Animal 2: not washed - Observation period (in vivo):
- 1 hour after instillation, 1, 2, 3, 4, 7, and 14 days thereafter
- Number of animals or in vitro replicates:
- 2 (one washed)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): in 1 animal, 1 minute with tap water
- Time after start of exposure: 20 seconds
SCORING SYSTEM:
- no formal scoring (detailed description of findings and rating in the summary)
TOOL USED TO ASSESS SCORE:
- hand-slit lamp
- biomicroscope with fluorescein 5% (after the day of treatment) - Irritation parameter:
- cornea opacity score
- Remarks:
- derived from verbal description of findings
- Basis:
- animal #2
- Remarks:
- not washed
- Time point:
- other: days 1 + 2
- Score:
- ca. 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days (trace microscopic change)
- Remarks on result:
- other: Localized injury on day 1, moderate edema on day 2
- Irritation parameter:
- cornea opacity score
- Remarks:
- derived from verbal description of findings
- Basis:
- animal #2
- Remarks:
- not washed
- Time point:
- other: days 3 - 4
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days (trace microscopic change)
- Remarks on result:
- other: slight microscopic change
- Irritation parameter:
- iris score
- Remarks:
- derived from verbal description of findings
- Basis:
- animal #2
- Remarks:
- not washed
- Time point:
- other: days 1 + 2
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 3 days
- Remarks on result:
- other: Minimal congestion at 1 hour, slight at 2 days (possibly due to animal having rubbed the eye)
- Irritation parameter:
- conjunctivae score
- Remarks:
- derived from verbal description of findings
- Basis:
- animal #2
- Remarks:
- not washed
- Time point:
- other: 1 hour
- Score:
- ca. 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Moderate swelling and discharge, mild redness
- Irritation parameter:
- conjunctivae score
- Remarks:
- derived from verbal description of findings
- Basis:
- animal #2
- Remarks:
- not washed
- Time point:
- other: day 4
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Mild irritation
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1992-11-16 to 1992-12-16
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- other: Kleine Weisse Russen, strain Chbb:HM, SPF
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Kleine Weisse Russen, strain Chbb:HM, SPF
- Age at study initiation: adult
- Weight at study initiation: 2 - 3 kg
- Housing: conventional, individual animals in stainless steel cages
- Diet: ad libitum, Ssniff K 4 Alleindiaet fuer Kaninchen
- Water: communal drinking water ad libitum
- Acclimation period: > 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12
IN-LIFE DATES: From: 1992-11-16 To: 1992-12-07 - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 cm3 liquid test substance placed into the conjunctival sac of one eye
- Untreated eye serves as control
VEHICLE
- none - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 1, 24, 48, 72 hours, 6, 8, 10, 13, 17, 20 days after application
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: with warm physiological saline
- Time after start of exposure: 24 hours after application (after fluorescein test)
FLUORESCEIN TEST
- 24, 48, 72 hours and 6 days after application
SCORING SYSTEM: OECD Guideline 405: Table 1: Grading of ocular lesions
TOOL USED TO ASSESS SCORE: hand-slit lamp / fluorescein - Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 20 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 17 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 17 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 20 d
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 17 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 17 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 17 d
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.45
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks:
- no changes at any time point
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.78
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 d
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 d
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 d
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
Referenceopen allclose all
Instilllation of trimethy orthoformate produced moderate corneal injury, slight transient iritic congestion, and mild conjunctivitis; only minimal microscopic corneal effects were noted at 7 -14 days.
Prompt washing was ineffective in reducing injury.
Time post application |
|
1 h |
|
|
24 h |
|
|
48 h |
|
|
72 h |
|
|
6 d |
|
8, |
10, |
13 d |
|
17 d |
|
|
20 d |
|
Animal |
1 |
2 |
3 |
1 |
2 |
3 |
1 |
2 |
3 |
1 |
2 |
3 |
1 |
2 |
3 |
1 |
2 |
3 |
1 |
2 |
3 |
1 |
2 |
3 |
Conjunctivae: erythema |
2 |
2 |
2 |
2 |
3 |
3 |
2 |
3 |
3 |
2 |
3 |
3 |
2 |
2 |
2 |
1 |
1 |
1 |
0 |
0 |
1 |
0 |
||
Conjunctivae: chemosis |
1 |
2 |
2 |
1 |
2 |
2 |
1 |
2 |
2 |
1 |
2 |
2 |
1 |
1 |
1 |
1 |
0 |
1 |
0 |
0 |
0 |
0 |
||
Iris |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
0 |
Cornea |
1 |
1 |
1 |
0 |
1 |
1 |
0 |
1 |
2 |
0 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
0 |
Examination w. fluorescein |
|
|
0 |
3 |
4 |
0 |
3 |
1 |
0 |
1 |
1 |
0 |
0 |
0 |
|
|
|
|||||||
Exudation |
x |
x |
x |
|
x |
x |
|
x |
x |
|
|
|
|
|
|
|||||||||
Exudation (white, slimy) |
x |
|
|
|
x |
x |
|
x |
x |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Conjunctivae incl. nictitating membrane: bleeding |
|
|
|
slight |
severe |
severe |
x |
x |
x |
x |
x |
x |
|
|
|
|
|
|
|
|
|
|
|
|
Iris: reddened |
|
|
|
|
x |
x |
|
x |
x |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
From the numerical scores of the individual animals at 24, 48, and 72 hours, the following averages were calculated:
|
Animal 1 |
Animal 2 |
Animal 3 |
Average |
Conjunctivae: erythema |
2.00 |
3.00 |
3.00 |
2.67 |
Conjunctivae: chemosis |
1.00 |
2.00 |
2.00 |
1.67 |
Iris |
0 |
0.67 |
0.67 |
0.45 |
Cornea |
0 |
1.00 |
1.33 |
0.78 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Additional information
Skin:
A key study conducted 1992 according to guideline OECD 404 and under GLP is available. The study is considered to be relevant, reliable (Klimisch 1) and adequate for the purposes of risk assessment, classification and labelling. No irritating effect was observed in any of the three rabbits tested.
A supporting study (non-GLP, 1962) with much higher doses and 6-hour exposure essentially confirms these findings; the author concludes that trimethyl orthoformate is non-irritating, although slight transient erythema was observed in one animal.
No skin irritation was found during the dermal induction phase in two guinea pig sensitisation studies (cf. section 7.4.1).
Eye:
A key study conducted 1992 according to guideline OECD 405 and under GLP is available. The study is considered to be relevant, reliable (Klimisch 1) and adequate for the purposes of risk assessment, classification and labelling. Corneal opacity (3-day average score 0.78) and iritis (average score 0.45) were reversible in 6 days. Erythema (average score 2.67) and chemosis (average score 1.67) of the conjunctivae were reversible within 17-20 days.
A supporting study (non-GLP, 1962) essentially confirms the findings; corneal effects subsided to trace microscopic changes after 14 days. Immediate washing with tap water did not reduce the effects.
Respiratory:
Clear signs of respiratory irritation were observed in a rat inhalation toxicity study (cf. section 7.2.2).
Effects on eye irritation: moderately irritating
Effects on respiratory irritation: irritating
Justification for classification or non-classification
Based on the eye irritation effects observed in eye irritation studies and respiratory irritation effects observed in rat acute inhaltion toxicity studies, the substance meets GHS classification criteria for serious eye damage/irritation category 2 (H319) and STOT-respiratory tract irritation - single exposure category 3 (H335)
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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