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EC number: 211-706-5 | CAS number: 688-74-4
- 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
Tributyl borate is rapidly hydrolyzed to Boric acid and n-Butanol in the presence of water or moisture in the air (18.3 sec at 21°C). Reliable data of the hydrolysis products n-Butanol and Boric acid are used to address the endpoint, which is considered entirely appropriate for the assessment of the skin and eye corrosion/irritation potential of Tributyl borate:
1) Hydrolysis product n-Butanol
- Skin irritation [in vivo study; Vienna White rabbits; occlusive; shaved; no vehicle; 5min, 1h and 2h exposure (no guideline followed, non-GLP)]: Category 2 (irritant) based on EU-GHS criteria;
- Eye irritation [in vivo study; New Zealand White rabbits; no vehicle; no wash-out (OECD 405, GLP)]: Category 1 (irreversible effects on the eye) based on EU-GHS criteria.
2) Hydrolysis product Boric acid
- Skin irritation [in vivo study; New Zealand White rabbits; occlusive; abraded; vehicle: physiological saline; 24h exposure (FIFRA (40 CFR 163)); non-GLP]: not irritating based on EU-GHS criteria;
- Eye irritation [in vivo study; New Zealand White rabbits; no vehicle; rinsed with physiological saline; 24h exposure (FIFRA (40 CFR 163)); non-GLP]: not irritating based on EU-GHS criteria.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- other: experimental study on hydrolysis product Boric acid
- Adequacy of study:
- key study
- Study period:
- No data
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: FIFRA (40 CFR 163)
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- Study pre-dates GLP
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan F Plummer
- Weight at study initiation: 1623 - 2922 g - Type of coverage:
- occlusive
- Preparation of test site:
- abraded
- Vehicle:
- physiological saline
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g
- Concentration: Moistened with physiological saline. - Duration of treatment / exposure:
- 24 h
- Observation period:
- 72 h
- Number of animals:
- 10
- Details on study design:
- TEST SITE
- Area of exposure: Saddle area
- Type of wrap if used: Occlusive
REMOVAL OF TEST SUBSTANCE
- Washing: Moistened towel
- Time after start of exposure: 24 h
SCORING SYSTEM: Draize - Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 0.1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritant / corrosive response data:
- No irritancy was observed
- Other effects:
- No data
- Interpretation of results:
- other: Not classifiable in the EU
- Remarks:
- Criteria used for interpretation of results: other: Classified in US Toxicity Category IV (slight or no irritation)
- Conclusions:
- The study was performed according to FIFRA (40 CFR 163). No irritancy was observed and it is therefore not classifiable in the EU.
Classified in US in Toxicity Category IV (slight or no irritation).
Data from other studies confirm the results. Further testing not warranted in the interests of animal welfare. - Endpoint:
- skin irritation: in vivo
- Type of information:
- other: experimental study on hydrolysis product n-Butanol
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Principles of method if other than guideline:
- Two rabbits were exposed to the test substance for 5 minutes, 1 hour and 2 hours under occlusive conditions. The animals were observed for 8 days.
- GLP compliance:
- no
- Specific details on test material used for the study:
- product No. 03331, 78/305
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2.97 - 3.4 kg
ENVIRONMENTAL CONDITIONS
no data - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin of the same animals
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml - Duration of treatment / exposure:
- 5 minutes, 1 hour and 2 hours
- Observation period:
- 8 days
- Number of animals:
- two animals per exposure period
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- exposure for 2 hours
- Time point:
- other: 24/48/72 hours
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- other: superficial necrosis
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- exposure for 2 hours
- Time point:
- other: 24/ 48/ 72 hours
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 d
- Remarks on result:
- other: superficial necrosis
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- exposure for 2 hours
- Time point:
- other: 24/48/ 72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- other: edema extending beyond the area of exposure
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- exposure for 2 hours
- Time point:
- other: 24/ 48/ 72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 d
- Remarks on result:
- other: extending beyond the area of exposure
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- exposure for 1 hour
- Time point:
- other: 24/48 hours
- Score:
- 2.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: scaling
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- exposure for 1 hour
- Time point:
- other: 24/48 hours
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 d
- Remarks on result:
- other: bloody crust, superficial necrosis
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- exposure for 1 hour
- Time point:
- other: 24/48 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- exposure for 1 hour
- Time point:
- other: 24/ 48 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 d
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- exposure for 5 min
- Time point:
- other: 24/48/ 72 hours
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- exposure for 5 min
- Time point:
- other: 24/ 48/ 72 hours
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 d
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- exposure for 5 min
- Time point:
- other: 24/48/ 72 hours
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- exposure for 5 min
- Time point:
- other: 24/48/ 72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 d
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
Referenceopen allclose all
Results for skin irritation:
Site |
Time |
Erythema |
Edema |
Intact |
24 h |
0 |
0 |
72 h |
0.25 |
0 |
|
Abraded |
24 h |
0 |
0 |
72 h |
0.17 |
0 |
|
Average score |
24 h, 72 h |
0.105 |
0 |
Exposure for 2 hours under occlusive conditions led to superficial necrosis. No full thickness destruction of the skin occurred.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- other: experimental study on hydrolysis product Boric acid
- Adequacy of study:
- key study
- Study period:
- No data
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study.
- Qualifier:
- according to guideline
- Guideline:
- other: FIFRA (40 CFR 158, 162); TSCA (40 CFR 798). Although not carried out to an OECD protocol, the study has been carried out to a US EPA acceptable protocol and conducted in accordance with GLP standards (40CFR160).
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Approved USDA supplier - Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 100 mg boric acid was applied to one eye of each of 6 rabbits.
- Concentration: Boric acid used at up to 5 % in eye washes - Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- 6 animals
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: Rinsed with physiological saline
- Time after start of exposure: 24 h
SCORING SYSTEM: According to Draize, reported as according to EU 67/548/EEC - Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: Average 24, 48, 72 h
- Score:
- 13.6
- Max. score:
- 110
- Reversibility:
- fully reversible
- Remarks on result:
- other: Average 60 min score was 0.17
- Irritant / corrosive response data:
- Slightly irritating
Changes in colouration and texture of the eye and blistered appearance to conjunctiva.
Chemosis and redness reversed by seven days. - Other effects:
- No data
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Toxicity Category III - corneal involvement or irritation clearing in 7 days or less. Criteria used for interpretation of results: other: EU directive 67/548/EEC
- Conclusions:
- The study was performed according to FIFRA (40 CFR 158, 162); TSCA (40 CFR 7998). Minor effects on the iris and effects on the conjunctivae were reversed by Day 7. Not classifiable in the EU under directive 67/548/EEC.
Classified in US category III (40 CFR 156) "corneal involvement or irritation clearing in 7 days or less".
Non irritant under US CPS (16 CFR 15000.42). - Endpoint:
- eye irritation: in vivo
- Type of information:
- other: experimental study on hydrolysis product n-Butanol
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG, own breeding facilities
- Age at study initiation: ca. 3-5 months
- Weight at study initiation: 2.7 - 3.2 kg
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +- 3
- Humidity (%): 50 +- 20
- Air changes (per hr): fully air conditioned room
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- not rinsed
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): physiological sodium chloride solution
- Time after start of exposure: 24 hours
SCORING SYSTEM: according to OECD guideline 405
TOOL USED TO ASSESS SCORE: fluorescein (not at all readings) - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24/48/72 hours
- Score:
- 2.11
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24/48/72 hours
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24/48/72 hours
- Score:
- 2.89
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24/48/72 hours
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
Referenceopen allclose all
Results of the eye irritation study:
Score (average of animals investigated) |
Cornea |
Iris |
Conjunctiva |
|
Redness |
Chemosis |
|||
0 to 4 |
0 to 2 |
0 to 3 |
0 to 4 |
|
60 min |
0.17 |
0.83 |
1.00 |
1.67 |
24 h |
0.00 |
0.33 |
1.00 |
0.83 |
48 h |
0.00 |
0.00 |
1.00 |
0.50 |
72 h |
0.00 |
0.00 |
0.83 |
0.33 |
Average 24 h, 48 h, 72 h |
0.00 |
0.11 |
0.94 |
0.56 |
Reversibility* |
|
c |
c |
c |
Average time for reversion |
|
By 48 h |
By 7 d |
By 7 d |
*complete
Time p.a. | 1 h | 24 h | 48 h | 72 h | 7 d | ||||||||||
Animal No. | 1 | 2 | 3 | 1 | 2 | 3 | 1 | 2 | 3 | 1 | 2 | 3 | 1 | 2 | 3 |
Conjunctival swelling | 3 | 3 | 3 | 3 | 3 | 3 | 4 | 3 | 3 | 3 | 3 | 2 | 3 | 3 | 1 |
Conjunctival reddening | 2 | 2 | 1 | 3 | 3 | 2 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 2 |
Iris | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | + | 1 | 1 | + | 1 | 0 |
Corneal opacity | 1 | 1 | 1 | 2 | 1 | 1 | 4 | 2 | 1 | 4 | 2 | 2 | 4 | 2 | 2 |
Eye discharge: clear, uncoloured | x | x | x | ||||||||||||
Eye discharge: white, smeary | x | x | x | x | x | x | x | x | x | x | x | x | |||
Conjunctiva: white-coloured | x | ||||||||||||||
Conjunctiva: with bleeding | x | x | x | x | |||||||||||
Iris: reddened | x | x | x | x | x | x | x | x | x | x | x | x | |||
Iris: due to intense clouding not readable | x | x | x | ||||||||||||
Cornea: vascularization - weak distinct | x | ||||||||||||||
Cornea: vascularization - clearly distinct | x | x | |||||||||||||
Cornea: rough | x |
+ could not be assesst due to severe opacity
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Remarks on eye irritation classification
1) Hydrolysis product Boric acid
The hydrolysis product boric acid does not meet the criteria for classification and labelling for this endpoint.
2) Hydrolysis product n-Butanol
In a data compilation to rank various chemicals for eye irritancy, n-Butanol showed moderate corneal opacity, iritis and conjunctivitis, which were reversible within 7 days (1) (2). Moreover, a large data set from individual animals and laboratories reported by Weil and Scala (3) showed a wide variability in susceptibility/sensitivity towards this test material.
In conclusion, n-Butanol is considered to be moderately to strongly irritant to the rabbit eye, but the effects seem to be reversible (contrary to the results of the endpoint study record provided). Based on this information, Tributyl borate is not classified as Eye Dam. 1 (H318), but as Eye Irrit. 2 (H319).
References:
(1) ECETOC. 1998. Eye irritation: reference chemicals data bank, 2nd ed. Technical report 48. European Centre for Ecotoxicology and Toxicology of Chemicals, Brussels, Belgium, pp 72-73.
(2) Bagley DM, Gardner JR, Holland G, Lewis, Vrijhof H, Walker AP. 1999. Eye Irritation, updated reference chemicals data bank. Toxicology in vitro 13:505-510.
(3) Weil CS, Scala RA. 1971. Study of intra- and interlaboratory variability in the results of rabbit eye and skin irritation tests. Toxicol Appl Pharmacol 19:276-360.
Justification for classification or non-classification
Skin irritation:
according to CLP classification criteria and based on the classification and labelling requirement for the hydrolysis product n-Butanol, the substance Tributyl borate meets the criteria for classification and labelling for this endpoint, as set out in Regulation (EC) No 1272/2008: Category 2; H315: causes skin irritation.
Eye irritation:
according to CLP classification criteria and based on the classification and labelling requirement for the hydrolysis product n-Butanol, the substance Tributyl borate meets the criteria for classification and labelling for this endpoint, as set out in Regulation (EC) No 1272/2008: Category 2; H319: causes serious eye irritation.
Respiratory irritation:
Due to its suspected respiratory irritating property the substance Tributyl borate is classified (such as n-Butanol) for specific target organ toxicity after single exposure (STOT SE) into Category 3 and labeled with H335: may cause respiratory irritation under Regulation (EC) No 1272/2008.
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