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Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
other: read across from analogue substance
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study has been presented to ECHA in the framework of a NONS notification. The document is now public because presented more than 12 years ago. The summary received is from migrated NONS dossier

Data source

Reference
Reference Type:
other: body responsible for the test
Title:
Unnamed
Year:
1988

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
LLNA method not available at the time of testing

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
402-420-3
EC Name:
-
Molecular formula:
C31H19ClN7Na5O19S6
IUPAC Name:
sodium (E)-2-(4-(4-chloro-6-(7-((1,5-disulfonatonaphthalen-2-yl)diazenyl)-8-hydroxy-3,6-disulfonatonaphthalen-1-ylamino)-1,3,5-triazin-2-ylamino)phenylsulfonyl)ethyl sulfate
Test material form:
solid: particulate/powder

In vivo test system

Test animals

Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: HOECHST AG, Kastengrund
- Weight at study initiation: 232 g mean weight
- Housing: 5/cage
- Diet (ad libitum): Altromin 3112
- Water (ad libitum): tap water
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): 50 ± 20 %
- Air changes (per hr): -
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 25.10.1988 To: 18.11.1988

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
physiological saline
Concentration / amount:
1% / 4 * 0.1 mL
Day(s)/duration:
Day 1 / single injections
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Route:
epicutaneous, occlusive
Vehicle:
physiological saline
Concentration / amount:
25 % / 0.5 mL
Day(s)/duration:
Day 9 for 48 h
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
physiological saline
Concentration / amount:
25% / 0.5 mL
Day(s)/duration:
Day 22 for 24 h
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
Number of animals in test group: 20
Number of animals in negative control group: 10
Number of animals in challenge control group: 5
Challenge controls:
5 animals, challenge treatment on Day 14 for 24 h
Positive control substance(s):
yes
Remarks:
bi-annual test for validity of test system

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
25%
No. with + reactions:
0
Total no. in group:
10
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
25%
No. with + reactions:
1
Total no. in group:
10
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
mean skin thickness: 0.83; 0/5 acanthosis; 3/5 mononuclear infiltration grade 1
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
25%
No. with + reactions:
0
Total no. in group:
5
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
5
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
25%
No. with + reactions:
1
Total no. in group:
10
Clinical observations:
mean skin thickness: 0.73; 8/10 acanthosis grade 1; 5/10 mononuclear infiltration grade 1, 1/10 mononuclear infiltration grade 2
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
mean skin thickness: 0.73; 0/10 acanthosis; 0/10 mononuclear infiltration

Any other information on results incl. tables

After the challenge treatment, two out of 20 animals from the treatment group exhibited a slightly greater infiltration of the corium compared with the control animals.

Since any skin reaction which may have been present could not be determined visually due to the colour of the test substance itself, the evaluation was performed by means of measurement of the skin thickness.

Applicant's summary and conclusion

Interpretation of results:
other: not classified under Regulation 1272/2008
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The substance was tested for skin sensitisation following EU Method B6 (GPMT). Under the experimental conditions the substance does not show any skin sensitizing properties.
Executive summary:

The substance was tested for skin sensitisation following EU Method B6 (GPMT). Under the experimental conditions the substance does not show any skin sensitizing properties.

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