Boronic acid, B-(6-hydroxy-2-naphthalenyl)-

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2013-11-14 to 2013-11-26

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Carried out under GLP conditions and under OECD and EU methods.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2014

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)

Deviations:

no

GLP compliance:

yes

Type of study:

mouse local lymph node assay (LLNA)

Test material

Test material information

Constituent 1

Reference substance name:

(6-hydroxynaphthalen-2-yl)boronic acid

EC Number:

687-349-8

Cas Number:

173194-95-1

Molecular formula:

C10H9BO3

IUPAC Name:

(6-hydroxynaphthalen-2-yl)boronic acid

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Storage condition of test material: room temperature until 14 October 2013 then approximately 4 °C in the dark

In vivo test system

Test animals

Species:

mouse

Strain:

CBA

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Harlan Laboratories UK
- Age at study initiation: eight to twelve weeks old
- Weight at study initiation: 15 to 23 g
- Housing: individually housed in suspended solid floor polypropylene cages furnished with softwood woodflakes.
- Diet (e.g. ad libitum): 2014C Teklad Global Rodent diet
- Water (e.g. ad libitum): Free access to mains tap water
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25 °C
- Humidity (%): 30 to 70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (LLNA)

Vehicle:

dimethylformamide

Concentration:

50% , 25% or 10% w/w

No. of animals per dose:

4

Details on study design:

RANGE FINDING TESTS:
- Compound solubility: Soluble
- Irritation: No signs of systemic toxicity, visual local skin irritation or irritation indicated by an equal to or greater than 25% increase in mean ear thickness were noted

MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: LLNA
- Criteria used to consider a positive response: A mean ear thickness increase of equal to or greater than 25% was considered to indicate excessive irritation and limited biological relevance to the endpoint of sensitization.

Results and discussion

Positive control results:

None

In vivo (LLNA)

Results

Results 1

Parameter:

SI

Remarks on result:

other: Concentration (% w/w) in dimethyl formamide - Stimulation Index - Result 10 9.18 Positive 25 12.07 Positive 50 9.62 Positive

Results 2

Parameter:

other: disintegrations per minute (DPM)

Remarks on result:

other: Concentration (% w/w) in dimethyl formamide - dpm - dpm/Node a - Stimulation Index b - Result 21515.04 2689.38 na na 10 197450.90 24681.36 9.18 Positive 25 259725.20 32465.65 12.07 Positive 50 207039.40 25879.93 9.62 Positive

Any other information on results incl. tables

Disintegrations per minute

Concentration (% w/w) in dimethyl formamide	dpm	dpm/Node a	Stimulation Index b	Result
Vehicle	21515.04	2689.38	na	na
10	197450.90	24681.36	9.18	Positive
25	259725.20	32465.65	12.07	Positive
50	207039.40	25879.93	9.62	Positive

Applicant's summary and conclusion

Interpretation of results:

sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test item was considered to be a sensitizer under the conditions of the test.

Executive summary:

.