Registration Dossier

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:
supporting study
Study period:
1988
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:
Comparative studies of the sensitization potential of Morpholine, 2-mercaptobenzothiazole and 2 of their derivatives in guinea pigs
Author:
Wang X & Suskind RR
Year:
1988
Bibliographic source:
Contact Dermatitis 19: 11-15

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
A modification of Buehler's method was employed in this study.
GLP compliance:
not specified
Type of study:
Buehler test

Test material

Constituent 1
Chemical structure
Reference substance name:
Morpholine
EC Number:
203-815-1
EC Name:
Morpholine
Cas Number:
110-91-8
Molecular formula:
C4H9NO
IUPAC Name:
morpholine
Test material form:
liquid

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Breeding Lab.
- Age at study initiation: 5 - 6 weeks
- Weight at study initiation: 350 - 450 g
- Housing: individual cages
- Diet: pellet diet

ENVIRONMENTAL CONDITIONS
- Temperature: 21 ± 1 [70 ± 2° F]
- Humidity: 45 %
- Air changes: 10 changes/hour
- Photoperiod: 12 hours dark/12 hours light

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Challenge
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
No. of animals per dose:
10 animals
Details on study design:
RANGE FINDING TEST: yes

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 6
- Exposure period: 24 h
- Test groups: Morpholine in petrolatum
- Control group: Pure white petrolatum only
- Site: shaved nape
- Frequency of applications: ca. every 2nd day
- Duration: 0 - 14 d
- Concentrations: 5% (amount noted to produce minimal-intensity erythema)

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: (15)
- Exposure period: 24 h
- Test groups: Morpholine in petrolatum
- Control group: Pure white petrolatum only
- Site: left flank
- Concentrations: 0.1, 0.5, 2 %
- Evaluation: 1, 24, 48 h and 7 days after removal

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.1% Morpholine
No. with + reactions:
0
Total no. in group:
10
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.5 % Morpholine
No. with + reactions:
0
Total no. in group:
10
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
2% Morpholine
No. with + reactions:
0
Total no. in group:
10
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
0.1% Morpholine
No. with + reactions:
0
Total no. in group:
10
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
0.5% Morpholine
No. with + reactions:
0
Total no. in group:
10
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
2% Morpholine
No. with + reactions:
0
Total no. in group:
10

Any other information on results incl. tables

The sensitizing potential of Morpholine was tested on 10 guinea pigs by Buehler's method. Morpholine (2 %in Vaseline) proved not to be skin sensitizing. Thus, the Morpholine ring alone was incapable of inducing sensitization. A positive reaction in animals sensitized to 4,4-'dithiodimorpholine was attributed by the authors to irritation in hypersensitive animals.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met

Categories Display