2-hydroxypyridine 1-oxide

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

Data is from peer reviewed journal

Data source

Reference

Reference Type:

publication

Title:

Safety Assessment of 2-Amino-3-Hydroxypyridine as Used in Cosmetics

Author:

Cosmetic Ingredient Review Expert Panel

Year:

2014

Bibliographic source:

Cosmetic Ingredient Review; Final Report-2014

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

The contact hypersensitivity of test chemical 2-amino-3-hydroxypyridine (CAS No: 16867-03-1) was assessed in a local lymph node assay (LLNA) in CBA female mice.

GLP compliance:

not specified

Type of study:

mouse local lymph node assay (LLNA)

Justification for non-LLNA method:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

2-Amino-3-hydroxypyridine

Cas Number:

16867-03-1

Molecular formula:

C5H6N2O

IUPAC Name:

2-Amino-3-hydroxypyridine

Test material form:

solid

Details on test material:

- Name of test material (as cited in study report): 2-amino-3-hydroxypyridine
- Molecular formula: C5H6N2O
- Molecular weight: 110.115 g/mol
- Substance type: organic
- Physical state: solid
-Smiles: c1(c(nccc1)N)O
-InChI: 1S/C5H6N2O/c6-5-4(8)2-1-3-7-5/h1-3,8H,(H2,6,7)

Specific details on test material used for the study:

- Name of test material (as cited in study report): 2-amino-3-hydroxypyridine
- Molecular formula: C5H6N2O
- Molecular weight: 110.115 g/mol
- Substance type: organic
- Physical state: solid
-Smiles: c1(c(nccc1)N)O
-InChI: 1S/C5H6N2O/c6-5-4(8)2-1-3-7-5/h1-3,8H,(H2,6,7)

In vivo test system

Test animals

Species:

mouse

Strain:

CBA

Sex:

female

Details on test animals and environmental conditions:

No data available

Study design: in vivo (LLNA)

Vehicle:

other: ethanol:water (7:3, v/v)

Concentration:

0%, 5%, 25%, or 50%

No. of animals per dose:

Mice were divided into groups of 5.

Details on study design:

CBA female mice were divided into groups of 5 and received 0%, 5%, 25%, or 50% of the test material in ethanol:water (7:3, v/v) on the ear surface (25 μl/ear) once daily for 3 consecutive days. Clinical signs of toxicity were assessed daily, body weights were measured on days 1 and 6, and on day 3, skin reactions were assessed. On day 6, all animals were injected intravenous-ly with 20μCi [3H] methyl thymidine and the proliferation of lymphocytes in the draining lymph nodes was measured.

Statistics:

The stimulation indices (SI) were calculated.

Results and discussion

In vivo (LLNA)

Results

Results 1

Parameter:

SI

Value:

9

Test group / Remarks:

at 5% concentration

Remarks on result:

other: No indication of sensitization.

Results 2

Parameter:

SI

Value:

1.7

Test group / Remarks:

at 25% concentration

Remarks on result:

other: No indication of sensitization.

Results 3

Parameter:

SI

Value:

1.9

Test group / Remarks:

at 50% concentration

Remarks on result:

other: No indication of sensitization.

Cellular proliferation data / Observations:

No clinical signs of toxicity, deaths, or skin reactions occurred during the treatment period in any dose group. Visual observations found the lymph nodes were all of equal size.

Any other information on results incl. tables

The mean disintegrations per minute (DMP)/animal

0%: 113

5% : 332

25%: 192

50%: 220

Applicant's summary and conclusion

Interpretation of results:

other: not sensitizing

Conclusions:

There was no indication that 2-amino-3-hydroxypyridine (CAS No: 16867-03-1) could elicit an SI greater than 3. Thus it was considered that 2-amino-3-hydroxypyridine (CAS No: 16867-03-1) was not a skin sensitizer in this LLNA.

Executive summary:

The contact hypersensitivity of test chemical 2-amino-3-hydroxypyridine (CAS No: 16867-03-1) was assessed in a local lymph node assay (LLNA)in CBA female mice.

 

CBA female mice were divided into groups of 5 and received 0%, 5%, 25%, or 50% of the test material in ethanol:water (7:3, v/v) on the ear surface (25 μl/ear) once daily for 3 consecutive days. Clinical signs of toxicity were assessed daily, body weights were measured on days 1 and 6, and on day 3, skin reactions were assessed. On day 6, all animals were injected intravenous-ly with 20μCi [3H] methyl thymidine and the proliferation of lymphocytes in the draining lymph nodes was measured andThe stimulation indices (SI) were calculated.

 

The mean disintegrations per minute (DMP)/animal values for the each test group were 113, 332, 192, and 220 for the 0%, 5%, 25%, and 50% dose groups, respectively. The SI were 2.9, 1.7, and 1.9 for the 5%, 25%, and 50% dose groups, respectively.

 

No clinical signs of toxicity, deaths, or skin reactions occurred during the treatment period in any dose group. Visual observations found the lymph nodes were all of equal size.

 

Sincethere was no indication that 2-amino-3-hydroxypyridine(CAS No: 16867-03-1)could elicit an SI greater than 3, it was considered that 2-amino-3-hydroxypyridine(CAS No: 16867-03-1)was not a skin sensitizer in this LLNA