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Diss Factsheets

Toxicological information

Skin sensitisation

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Administrative data

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.
Justification for type of information:
Study conducted to GLP and in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not effect the quality of the relevant results. This study is conducted on an analogue substance. Read-across is justified on the following basis: In aqueous solutions at physiological and acidic pH, low concentrations of simple inorganic borates such as boric acid, disodium tetraborate decahydrate, disodium tetraborate pentahydrate, boric oxide and disodium octaborate tetrahydrate will predominantly exist as undissociated boric acid. At about pH 10 the metaborate anion (B(OH)4-) becomes the main species in solution (WHO, 1998). This leads to the conclusion that the main species in the plasma of mammals and in the environment is un-dissociated boric acid. Since other borates dissociate to form boric acid in aqueous solutions, they too can be considered to exist as un-dissociated boric acid under the same conditions. For comparative purposes, exposures to borates are often expressed in terms of boron (B) equivalents based on the fraction of boron in the source substance on a molecular weight basis. Some studies express dose in terms of B, whereas other studies express the dose in units of boric acid. Since the systemic effects and some of the local effects can be traced back to boric acid, results from one substance can be transferred to also evaluate the another substance on the basis of boron equivalents. Therefore data obtained from studies with these borates can be read across in the human health assessment for each individual substance. Conversion factors are given in the table below. Conversion factor for equivalent dose of B Boric acid H3BO3 0.175 Boric Oxide B2O3 0.311 Disodium tetraborate anhydrous Na2B4O7 0.215 Disodium tetraborate pentahydrate Na2B4O7•5H2O 0.148 Disodium tetraborate decahydrate Na2B4O7•10H2O 0.113 Disodium octaborate tetrahydrate Na2B8O13•4H2O 0.210 Sodium metaborate (anhydrous) NaBO2 0.1643 Sodium metaborate (dihydrate) NaBO2•2H2O 0.1062 Sodium metaborate (tetrahydrate) NaBO2•4H2O 0.0784 Sodium pentaborate (anhydrous) NaB5O8 0.2636 Sodium pentaborate (pentahydrate) NaB5O8∙5H2O 0.1832 References: WHO. Guidelines for drinking-water quality, Addendum to Volume 1, 1998.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (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.

Test material

Constituent 1
Reference substance name:
12179-04-3
Cas Number:
12179-04-3
IUPAC Name:
12179-04-3
Details on test material:
- Name of test material: Sodium tetraborate pentahydrate
- Physical state: White powder
- Analytical purity: > 99 %
- Lot/batch No.: 4ho2-2471
- Stability under test conditions: Stable

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male/female
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: Males: 314 -411 g; females: 256-441 g

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
0.4 g 95 % w/w substance.
Challengeopen allclose all
Route:
other: Not specified
Vehicle:
water
Concentration / amount:
0.4 g 95 % w/w substance.
No. of animals per dose:
Test group: 20 animals
Naive control: 10 animals
Positive control: 20 animals
Positive naive control: 10 animals
Details on study design:
A. INDUCTION EXPOSURE
- No. of exposures: Three
- Exposure period: Day 0, Day 7 and Day 21
- Test groups: 0.4 g 95 % w/w substance moistened with distilled water to enhance skin contact.
- Frequency of applications: Day 0, Day 7 and Day 21


B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: Day 28
- Exposure period: After 6 hours test substance wiped off with water
- Concentrations: 95 % w/w substance moistened with distilled water to enhance skin contact
- Evaluation: 24h & 48 h
Challenge controls:
No data
Positive control substance(s):
yes
Remarks:
Dinitrochlorobenzene

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.4 g 95 % w/w
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
None specified
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.4 g 95 % w/w. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: None specified.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.4 g 95 % w/w
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
None specified
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.4 g 95 % w/w. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: None specified.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
Not applicable
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
None specified
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: Not applicable. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None specified.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
Not applicable
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
None specified
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: Not applicable. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None specified.
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
Not specified
No. with + reactions:
10
Total no. in group:
20
Clinical observations:
Not specified
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: Not specified. No with. + reactions: 10.0. Total no. in groups: 20.0. Clinical observations: Not specified.
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
Not specified
No. with + reactions:
7
Total no. in group:
20
Clinical observations:
Not specified
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: Not specified. No with. + reactions: 7.0. Total no. in groups: 20.0. Clinical observations: Not specified.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
A study was performed according to OECD Guideline 406 "Skin Sensitisation" method (Buehler test ) using 95 % w/w disodium tetraborate pentahydrate moistened with distilled water to enhance skin contact. No irritation was observed.