Tris(1,3-dihydroxyprop-2-yl) borate

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

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

Adequacy of study:

key study

Study period:

No data

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study. Study conducted on the hydrolysis product of reference substance, boric acid.

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

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:

BH3O3

IUPAC Name:

Boric acid

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material: Boric acid
- Physical state: White powder
- Analytical purity: >99%
- Lot/batch No.: 4H25-3611

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: 282-376 g

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

epicutaneous, occlusive

Vehicle:

water

Induction 2

Concentration / amount:

Induction: 0.4 g 95 % w/w boric acid
Challenge: 95 % w/w boric acid

Challenge

Challenge 1

Route:

epicutaneous, occlusive

Vehicle:

water

Challenge 2

Concentration / amount:

Induction: 0.4 g 95 % w/w boric acid
Challenge: 95 % w/w boric acid

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:

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Concentrations: 0.4 g 95 % w/w boric acid moistened with distilled water to enhance skin contact.


B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: Day 28
- Exposure period: Test substance was wiped off with water after 6 h.

Challenge controls:

No data

Positive control substance(s):

yes

Remarks:

Dinitrochlorobenzene

Results and discussion

Positive control results:

No data

In vivo (non-LLNA)

Results

Reading:

1st reading

Hours after challenge:

34

Group:

test chemical

Dose level:

0.4 g 95% w/w/boric acid

No. with + reactions:

0

Total no. in group:

20

Clinical observations:

Very faint erythema seen in one animal at induction stage and 2 animals at challenge stage and also in one naïve control. No other adverse effect observed

Remarks on result:

other: see Remark

Remarks:

Reading: 1st reading. . Hours after challenge: 34.0. Group: test group. Dose level: 0.4 g 95% w/w/boric acid . No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: Very faint erythema seen in one animal at induction stage and 2 animals at challenge stage and also in one naïve control. No other adverse effect observed.

Any other information on results incl. tables

Observations:

Treatments	Buehler test	Observations/Remarks
	Day of treatment
Induction 1	day 0	Very faint erythema (0.5) observed at one test site at 24 hours after first induction dose. No other irritation observed
Induction 2	7	No irritation observed
Induction 3	14	No irritation observed
Challenge	28	No irritation observed
Scoring 1	29	Very faint erythema (0.5) observed at two test sites at 24 hours after  challenge dose. Irritation persisted at one site for 48 hours.  Very faint erythema (0.5) observed at one test site at 24 hours in one naive control.
Scoring 2	30

Results of skin sensitisation test:

	Number of animals with signs of allergic reactions / number of animals in group
	Negative control	Test group	Positive control
scored after 24h	0 / 10	0 / 20	10/20
scored after 48h	0 / 10	0 / 20	7/20

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

OECD Guide-line 406 "Skin Sensitisation" method (Buehler test ) was performed using 95 % w/w boric acid moistened with distilled water to enhance skin contact. Very faint erythema was observed in one animal at induction stage and 2 animals at challenge stage and also in one naïve control. No other adverse effects were observed therefore the test substance was considered a non-sensitiser.