Tributyl borate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

justification for analogue approach: see IUCLID section 13 "Read-across justification"

Cross-reference

Reason / purpose for cross-reference:

read-across source

Reference

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).

Materials and methods

Test material

Test material information

Constituent 1

Reference substance name:

Boric acid

EC Number:

233-139-2

EC Name:

Boric acid

Cas Number:

10043-35-3

Molecular formula:

H3BO3

IUPAC Name:

Boric acid

Details on test material:

- Name of test material: Boric acid
- Molecular formula: H3BO3
- Molecular weight: 61.8
- Smiles notation: B(OH)3
- Substance type: Inorganic
- Physical state: Solid
- Analytical purity: >99.9 % w/w
- Lot/batch No.: 8M8E
- Stability under test conditions: Stable
- Other: White powder and odourless

Results and discussion

In vivo

Results

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

Any other information on results incl. tables

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

Applicant's summary and conclusion

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).