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Toxicological information

Eye irritation

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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).

Data source

Materials and methods

Test material

Constituent 1
Chemical structure
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).