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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:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
publication
Title:
The sensitizing capacity of naturally occurring quinones - Experimental studies in guinea pigs. I. Naphthoquinones and related compounds
Author:
Schulz KH, Garbe I, Hausen BM and MH Simatupang
Year:
1977
Bibliographic source:
Arch. Derm. Res. 258, 41-52

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The test was initiated with two subcutaneous administrations of 0.1% Freund’s complete adjuvant (FCA) in physiological NaCl on hind legs at intervals of 4 days. The animals were challenged with the test substance by an epicutaneous application of 3 different molar concentrations of test substance to a 2 cm2 area on the flank. The intensity of the reactions was evaluated 24 and 48 hours after the challenge for erythema, infiltration and exsudation on the scale of 0-3 ranging from no reaction to intense erythema, infiltration and exsudation.
GLP compliance:
no
Type of study:
other: skin sensitization in vivo
Justification for non-LLNA method:
Study conducted prior to development of LLNA method

Test material

Constituent 1
Chemical structure
Reference substance name:
Menadione
EC Number:
200-372-6
EC Name:
Menadione
Cas Number:
58-27-5
Molecular formula:
C11H8O2
IUPAC Name:
2-methyl-1,4-dihydronaphthalene-1,4-dione
Specific details on test material used for the study:
MW: 172
origin: trade product (Merck)

In vivo test system

Test animals

Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
male
Details on test animals and environmental conditions:
The animal weight was 400-500g. The animals were fed with «Altrumin» and water ad libitum.

Study design: in vivo (non-LLNA)

Induction
Route:
other: subcutaneous
Vehicle:
other: Freund's complete adjuvant mixed 1+1 with physiol. NaCl solution
Concentration / amount:
0.1 mL of 0.005 molar emulsion per 500 g bw
Day(s)/duration:
2 times at intervals of 4 days
Challenge
No.:
#1
Route:
other: epicutaneous
Vehicle:
not specified
Concentration / amount:
1/100; 1/500; 1/1000 molar
Day(s)/duration:
Evaluation 24 and 48 hrs after challenge
No. of animals per dose:
12
Details on study design:
Reactions on skin were evaluated and a mean response for each group was calculated by summing the numerical readings and dividing the sum by the number of animals in the group.
Challenge controls:
The threshold level of primary irritation of the substance was determined before sensitization experiments by a single application of three different concentrations to the skin of non-sensitized control animals (resp. guinea pigs treated with Freund's adjuvant alone).
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
other: mean response
Hours after challenge:
48
Group:
test chemical
Dose level:
1/100 molar
No. with + reactions:
5
Total no. in group:
12
Clinical observations:
distinct confluent erythema and infiltration, distinct erythema
Remarks on result:
positive indication of skin sensitisation
Remarks:
Mean response 0.6
Reading:
other: mean response
Hours after challenge:
48
Group:
test chemical
Dose level:
1/500 molar
No. with + reactions:
1
Total no. in group:
12
Clinical observations:
slight spotted erythema
Remarks on result:
no indication of skin sensitisation
Remarks:
Mean response 0.04
Reading:
other: mean response
Hours after challenge:
48
Group:
test chemical
Dose level:
1/1000 molar
No. with + reactions:
0
Total no. in group:
12
Clinical observations:
no reaction
Remarks on result:
no indication of skin sensitisation

Any other information on results incl. tables

The results of the sensitization assay are presented in the table below. The reactions were scaled as follows:

(+) slight spotted erythema

+ distinct erythema

++ distinct confluent erythema and infiltration

+++ intense erythema, infiltration and exsudation

No reaction

 

 

 

Number of animals with a reaction

 

Animals / group

Dose group (molar)

+++

(score 3)

++

(score 2)

+

(score 1)

(+)

(score 0.5)

No reaction

(Score 0)

Mean response

12

1/100

-

2

3

-

7

0.6

12

1/500

-

-

-

1

11

0.04

12

1/1000

-

-

-

-

12

0.0

Applicant's summary and conclusion

Interpretation of results:
Category 1 (skin sensitising) based on GHS criteria
Conclusions:
Menadione showed a weak sensitizing effect in the guinea pigs.
Executive summary:

Menadione was tested in guinea pigs for skin sensitization. The animals were treated subcutaneously with FCA, followed by an epicutaneous administration of the test substance in three different concentrations. Skin reactions were observed 24 and 48 hours after the challenge. Menadione showed a weak sensitizing effect in the guinea pigs.