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Diss Factsheets

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

Referenceopen allclose all

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

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
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

Exposure for 2 hours under occlusive conditions led to superficial necrosis. No full thickness destruction of the skin occurred.

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

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

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

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
 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

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
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.