Registration Dossier

Administrative data

Description of key information

The test substance is not a skin sensitizer.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1988/89
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
number of animals
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Study was already available
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
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
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
Positive control results:
results not given in study report
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
25%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
mean skin thickness: 0.83; 4/5 acanthosis grade 1; 2/5 mononuclear infiltration grade 1
Remarks on result:
other: 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 and histopathological assessment of the skin.
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
mean skin thickness: 0.78; 0/5 acanthosis; 0/5 mononuclear infiltration
Remarks on result:
other: 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 and histopathological assessment of the skin.
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
25%
No. with + reactions:
1
Total no. in group:
10
Clinical observations:
mean skin thickness: 0.76; 8/10 acanthosis grade 1; 6/10 mononuclear infiltration grade 1, 1/10 mononuclear infiltration grade 2
Remarks on result:
no indication of skin sensitisation
Remarks:
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 and histopathological assessment of the skin.
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
mean skin thickness: 0.71; 0/10 acanthosis; 0/10 mononuclear infiltration
Remarks on result:
other: 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 and histopathological assessment of the skin.
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
25%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
mean skin thickness: 0.83; 0/5 acanthosis; 3/5 mononuclear infiltration grade 1
Remarks on result:
other: 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 and histopathological assessment of the skin.
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
mean skin thickness: 0.78; 0/5 acanthosis; 0/5 mononuclear infiltration
Remarks on result:
other: 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 and histopathological assessment of the skin.
Reading:
2nd reading
Hours after challenge:
72
Group:
test group
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
Remarks:
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 and histopathological assessment of the skin.
Reading:
2nd reading
Hours after challenge:
72
Group:
test group
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
Remarks on result:
other: 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 and histopathological assessment of the skin.

Other observations:
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.

Interpretation of results:
GHS criteria not met
Conclusions:
Reactiv-Red F52 167 FW, based on this expermient, is not a sensitizer
Executive summary:

The potential of sensitisation of Reactive Red F-52 167 FW was tested on the skin of Pirbright-White-Guinea pigs.

The intradermal Induction treatment was done with 1% of the test substance in 0.9% NaCl-solution. The dermal induction treatment was done with 25% test substance and 0.9% NaCl-solutions.

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 and hstopathological assessment of the skin..

Evaluation of the study results lead to the conclusion that the test substance is not a sensitizer.

Reactive Red F-52 167 FW, has not to be classified.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

The potential of sensitisation of Reactive Red F-52 167 FW was tested on the skin of Pirbright-White-Guinea pigs.

The intradermal Induction treatment was done with 1% of the test substance in 0.9% NaCl-solution. The dermal induction treatment was done with 25% test substance and 0.9% NaCl-solutions.

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 and histopathological assessment of the treated skin..

Evaluation of the study results lead to the conclusion that the test substance is not a sensitizer.

Reactive Red F-52 167 FW, has not to be classified.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

no sensitizing effect, no classification necessary