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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
30 Oct - 28 Dec 1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
no information on positive control

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report date:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
no
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Test conducted prior to development of the LLNA test method (1978).

Test material

Constituent 1
Chemical structure
Reference substance name:
3,7-bis(diethylamino)phenoxazin-5-ium acetate
EC Number:
279-349-8
EC Name:
3,7-bis(diethylamino)phenoxazin-5-ium acetate
Cas Number:
79916-07-7
Molecular formula:
C20H26N3O.C2H3O2
IUPAC Name:
3,7-bis(diethylamino)phenoxazin-5-ium acetate
Test material form:
solid
Details on test material:
Purity: 28.8%

In vivo test system

Test animals

Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: own breed
- Age at study initiation: ca. 10 wks
- Weight at study initiation: 270 - 360 g
- Housing: Macrolon type III cages
- Diet (e.g. ad libitum): ad lib.
- Water (e.g. ad libitum): ad lib.
- Acclimation period: 10 d
- Indication of any skin lesions: only healthy animals used

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 21°C
- Humidity (%): 50 - 60 % rh
- Photoperiod (hrs dark / hrs light): 14 / 10 h

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
physiological saline
Concentration / amount:
0.1%, 3 injections every 2nd day, 0.1 mL
Day(s)/duration:
Day 1 to 7 / 7 days
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Route:
intradermal
Vehicle:
physiological saline
Concentration / amount:
0.1%, vehicle : Bacto adjuvant 50:50, 7 injections every 2nd day
Day(s)/duration:
Day 8 to 22 / 14 days
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challengeopen allclose all
No.:
#1
Route:
intradermal
Vehicle:
physiological saline
Concentration / amount:
0.1% / 0.1 mL
Day(s)/duration:
Day 36 / single injection
Adequacy of challenge:
not specified
No.:
#2
Route:
epicutaneous, occlusive
Vehicle:
other: vaseline
Concentration / amount:
1%
Day(s)/duration:
Day 46 / 24 h
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
20 (10 males, 10 females)
Challenge controls:
Physiological saline
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0.1% test material intradermal
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
24
Group:
negative control
Dose level:
1% test material epicuteneous
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.1%, intradermal injection
No. with + reactions:
10
Total no. in group:
20
Clinical observations:
no erythema
Remarks on result:
other: based on skin-fold thickness
Key result
Reading:
2nd reading
Hours after challenge:
24
Group:
test chemical
Dose level:
1%, epicutaneous application
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no erythema
Remarks on result:
no indication of skin sensitisation
Remarks:
based on skin-fold thickness

Any other information on results incl. tables

Intradermal injection of the vehicle alone failed to induce sensitization.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The substance was not found to be skin sensitising in guinea pigs (GPMT).