Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
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:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPP 81-6 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
OECD Guide-line 406 "Skin Sensitisation" method (Buehler test ) was performed before the LLNA was set as preferred test method.
Species:
guinea pig
Strain:
other: Hartley albino
Sex:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Davidson’s Mill Farms, South Brunswick, NJ
- Age at study initiation: Young adult
- Weight at study initiation: 282 -411 grams
Route:
other: Topical
Vehicle:
water
Concentration / amount:
Concentration used for induction: 0.4 g 95 % w/w/boric acid
Concentration used for challenge: 95 % w/w/boric acid
Route:
other: No data
Vehicle:
water
Concentration / amount:
Concentration used for induction: 0.4 g 95 % w/w/boric acid
Concentration used for challenge: 95 % w/w/boric acid
No. of animals per dose:
20
Details on study design:
A. INDUCTION EXPOSURE
- No. of exposures: Three
- Test groups: Test substance moistened with distilled water to enhance skin contact.


B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: Day 28
- Test groups: Test substance moistened with distilled water to enhance skin contact.
- Concentrations: 95 % w/w/boric acid
- Evaluation (hr after challenge): 24 h and 48 h after challenge


OTHER:
- Removal of the test substance: After 6 h the test substance was wiped off with water.
Challenge controls:
No data
Positive control substance(s):
yes
Remarks:
Dinitrochlorobenzene
Statistics:
No data
Positive control results:
At 24 h 10 /20 animals in the positive control group had a score greater than 0.5 with a severity score of 0.80. At 48 h this number was reduced to 7/20 with a severity score of 0.53.
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
95 % boric acid
No. with + reactions:
3
Total no. in group:
20
Clinical observations:
Very faint erythema (0.5) was noted at three test sites 24 hours after first induction dose. No other adverse effect observed.
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 95 % boric acid. No with. + reactions: 3.0. Total no. in groups: 20.0. Clinical observations: Very faint erythema (0.5) was noted at three test sites 24 hours after first induction dose. No other adverse effect observed..
Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Disodium octaborate tetrahydrate was determined to be not sensitising in guinea pigs according to OECD Guideline 406.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Skin sensitisation

Disodium tetraborate decahydrate and disodium tetraborate pentahydratewere tested in a Buehler method skin sensitisation test (Wnorowski, 1994) applied at a concentration of 95 % (powder moistened with water) during both the induction and challenge phase of the test. No signs of skin sensitisation were observed. No evidence of skin sensitisation in humans exposed occupationally to borates has been reported (Bruze et al., 1995).


Migrated from Short description of key information:
A skin sensitisation test on disodium octaborate tetrahydrate was performed according to OECD Guideline 406 (Buehler method).

Justification for selection of skin sensitisation endpoint:
GLP guideline study conducted with disodium octaborate.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

There are no data to suggest that disodium octaborate tetrahydrate is respiratory sensitiser.


Migrated from Short description of key information:
There are no data to suggest that disodium tetraborates are respiratory sensitisers.

Justification for classification or non-classification

Disodium tetraborate is not a skin or respiratory sensitiser. In accordance with the criteria of EU CLP Regulation (EC) No. 1272/2008) disodium tetraborate does not need to be classified and labelled as a skin or respiratory sensitizer.