Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions (limited documentation, low dosing), acceptable for assessment

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Unnamed
Year:
1985
Reference Type:
review article or handbook
Title:
Unnamed
Year:
2003

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
as of 12 May 1981
Deviations:
yes
Remarks:
non-occlusive challenge treatment; FCA-water mixture not applied
Principles of method if other than guideline:
Guinea pig maximization test reported by Magnusson and Kligman 1969:
Comparative study including naphthalene, Naphthol AS [CAS No. 92-77-3], 2-naphthol [CAS No. 135-19-3] and 2-hydroxy-3-naphthoic acid [CAS No. 92-70-6]
GLP compliance:
not specified
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Chemical structure
Reference substance name:
Naphthalene
EC Number:
202-049-5
EC Name:
Naphthalene
Cas Number:
91-20-3
Molecular formula:
C10H8
IUPAC Name:
naphthalene
Details on test material:
- Name of test material (as cited in study report): naphthalene
- Supplier: Katayama Chemical Co., Ltd.
- Molecular formula (if other than submission substance): C10H8
- Molecular weight (if other than submission substance): 128.18
- Substance type: organic
- Physical state: solid
- Analytical purity: no data

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
body weight 300 - 350 g

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: paraffin oil and white vaseline (induction) / acetone (challenge)
Concentration / amount:
1 % (i.d induction); 10 % (epicutaneous induction) / 0.1 and 1 % (epicutaneous challenge)
Challengeopen allclose all
Route:
epicutaneous, open
Vehicle:
other: paraffin oil and white vaseline (induction) / acetone (challenge)
Concentration / amount:
1 % (i.d induction); 10 % (epicutaneous induction) / 0.1 and 1 % (epicutaneous challenge)
No. of animals per dose:
12 treated animals each;
12 in the untreated control group (only the vehicle)
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1 (i.d.); 1 (topical)
- Exposure period: 48 h topical
- Test groups: test substance
- Control group: no data (2-naphthol as surrogate)
- Site: shoulder
- Frequency of applications: day 0 (i.d.); day 7 (topical)
- Duration: 7 + 2 days
- Concentrations: First induction:
50 µL i.d. injected in 1 % of test substance in liquid paraffin
50 µL i.d. injected in 1 % of test substance in Freund´s complete adjuvants (FCA)
(Dose: 500 µg each)
Second induction: after 7 d: topically 10 % of test substance in vaseline (volume: no data) for 48 h (closed patch)

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 21
- Exposure period: 24 h
- Test groups: test substance
- Control group: no data (2-naphthol as surrogate)
- Site: flank
- Concentrations: 0.1 and 1 % in acetone
- Dosage volume: 20 µL/cm2
- Dose: 20 and 200 µg/cm2
- Evaluation (hr after challenge): 24 and 48 h
Challenge controls:
no data
Positive control substance(s):
not specified
Remarks:
No accepted standard mentioned: 2-naphthol proved the responsiveness of the test system.

Results and discussion

Positive control results:
2-Naphthol: 8/8 animals clearly positive

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.1 and 1 %
No. with + reactions:
0
Total no. in group:
24
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.1 and 1 %. No with. + reactions: 0.0. Total no. in groups: 24.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.1 and 1 %
No. with + reactions:
0
Total no. in group:
24
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.1 and 1 %. No with. + reactions: 0.0. Total no. in groups: 24.0.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Considering the quality of the reporting and the low challenge concentrations of naphthalene used, no firm conclusions can be drawn from this study (ECB 2003).
Executive summary:

In a poorly reported skin sensitisation study based on the guinea pig maximisation method, a 24-hour open application dermal challenge, with 0.1% or 1% naphthalene in acetone, did not produce any sign of a sensitisation reaction in any of the 24 animals. However no information was provided on the use of positive controls, and at the induction stage no signs of naphthalene-induced irritation were reported at the concentrations examined. However, 2-naphthol was also tested and was positive in all 16 animals tested.