Naphthalene-1,5-diol

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

other information

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: only as secondary citation available: guideline study and GLP

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes

Type of study:

mouse local lymph node assay (LLNA)

Test material

Test material information

Constituent 1

Reference substance name:

Naphthalene-1,5-diol

EC Number:

201-487-4

EC Name:

Naphthalene-1,5-diol

Cas Number:

83-56-7

Molecular formula:

C10H8O2

IUPAC Name:

naphthalene-1,5-diol

Test material form:

other: solid

Details on test material:

content: 99.9 %
batch no. 820211/01

In vivo test system

Test animals

Species:

mouse

Strain:

CBA

Sex:

female

Details on test animals and environmental conditions:

no data

Study design: in vivo (LLNA)

Vehicle:

acetone/olive oil (4:1 v/v)

Concentration:

Experiment I : 5, 25 and 50% in acetone /olive oil
Experiment II: 0.25, 1 and 2.5 % in acetone/olive oil

No. of animals per dose:

3 females per dose

Details on study design:

Experiment I:
Initially, 3 groups of animals were tested with 3 test substance concentrations, respectively.
Experiment II:
Based on the results, 3 additional groups were treated with 3 lower concentrations.

In each experiment, during the induction phase, the test item was applied over the dorsal ssurface of each ear (25 µl per ear) for 3 consecutive days (day1, 2, 3). On day 6 each animal was administered with radio-labeled thymidine (3HTdR) by intravenous injection. After 5 hours, the animals were euthanized and the draining lymph nodes were excised and pooled to prepare single cell suspension for each animal.
3HTdR incorporation was measured by scintillation counting. the proliferative response of lymph node cells was expressed as the ratio 3HTdRincorporation into lymph node cells of treated animals relatife to that recorded in control animals

Reference was made to separate experiments eith vehicle control animals and for reliability check with alpha-hexylcinnamaldehyde as positive control , respectively.

Positive control substance(s):

hexyl cinnamic aldehyde (CAS No 101-86-0)

Statistics:

no data

Results and discussion

In vivo (LLNA)

Results

Parameter:

SI

Remarks on result:

other: see Remark

Remarks:

Experiment I: concentration [%] / Stimulation Index (SI) : 5 / 18.4; 25 / 16.7; 50 / 6.1 Experiment II: concentration [%] / Stimulation Index (SI): 0.25 / 1.4; 1 / 2.5; 2.5 / 2.8 Based on these data an EC value of 3.4 % was calculated

Applicant's summary and conclusion

Executive summary:

SCCS (2010) describes the performance of a Local Lymph Node Assay (LLNA) according to OECD TG 429 and GLPand yielded positive result with a calculated EC3-value of 3.4 % . Based on the the potency categorisation given in ECHA Guidance Document R8 -10 (Version 2), 2010 it is concluded that 1,5-naphthalenediol is a moderate skin sensitizer.