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Administrative data

Description of key information

Skin sensitisation

Disodium octaborate tetrahydrate was tested in a Buehler method skin sensitisation test (Wnorowski, 1994) according to OECD 406 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).

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:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPP 81-6 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
OECD Guideline 406 "Skin Sensitisation" method (Buehler test) was performed before the LLNA was set as preferred test method.
Species:
guinea pig
Strain:
Hartley
Remarks:
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
Remarks:
moistened
Concentration / amount:
0.4 g of 95 % w/w DOT
No.:
#1
Route:
other: Topical
Vehicle:
water
Remarks:
moistened
Concentration / amount:
0.4 g of 95 % w/w DOT
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
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 chemical
Dose level:
0.4 g of 95 % DOT (moistened with distilled water)
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.4 g of 95 % DOT (moistened with distilled water)
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
0.03 % DNCB
No. with + reactions:
10
Total no. in group:
20
Remarks on result:
positive indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
0.03 % DNCB
No. with + reactions:
7
Total no. in group:
20
Remarks on result:
positive indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0.4 g of 95 % DOT (moistened with distilled water)
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0.4 g of 95 % DOT (moistened with distilled water)
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0.03 % DNCB
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0.03 % DNCB
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation

Very faint erythema (0.5) was noted at three test sites 24 hours after first induction dose.

Interpretation of results:
other: EU GHS criteria not met
Conclusions:
Disodium octaborate tetrahydrate was determined to be not sensitising in guinea pigs according to OECD Guideline 406.
Executive summary:

The test item disodium octaborate tetrahydrate has been evaluated for its sensitising potenial to skin in an OECD Guideline 406 "Skin Sensitisation" Buehler test according to GLP in guinea pigs. The test item has been applied at a concentration of 95 % (powder moistened with water) during both the induction and challenge phase of the test to 20 guinea pigs. No signs of skin sensitisation were observed.

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

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 a respiratory sensitiser.

Justification for classification or non-classification

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