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Administrative data

Description of key information

A guinea pig maximisation test was performed to determine the sensitization potential of FAT 40034/E according to the OECD Guideline 406.

Procedure:

Day 0: Induction: Three pairs of intradermal injections (0.1 ml per injection in physiological saline with 5 % concentration) were made simultaneously into the left and right side of the shaved neck of the test and control group animals.

Day 8: Induction: In the test group FAT 40034/E was incorporated in physiological saline and applied on a filter-paper patch to the neck of the animals (patch 2x4 cm; approx. 0.4 g per patch; occluded administration for 48 h). The control group was treated with the vehicle only. Test Concentration was 50 % FAT 40034/E in physiological saline

Day 21: Challenge: The test and control group animals were tested on one flank with the dyed textile patch moistened with distilled water, (patch 2x2 cm; approx. 0.2 g per patch; occluded administration for 24 h). The dyed textile patch moistened with distilled water.

Following the challenge, 10 % of the animals of the test group showed skin reactions 24 and 48 h after removing the dressings. Based on the study results FAT 40034/E does not meet the criteria for classification according to CLP (1272/2008) Regulation and is not considered as a sensitiser to rabbit skin.

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:
November 21, 1994 to February 15, 1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
not specified
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
not specified
GLP compliance:
yes (incl. QA statement)
Remarks:
Swiss GLP
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Data from a reliable in vivo test conducted before the enforcement of Commission Regulation (EU) 640/2012 of 06 July 2012 amending, for the purpose of its adaptation to technical progress, Regulation (EC) No 440/2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) are available.
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch number of test material: SUPER D/ll/94
- Expiration date of the lot/batch: December, 1999

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: CIBA-GEIGY Limited Animal Production 4332 Stein / Switzerland
- Weight at study initiation: 311 to 419 g
- Housing: individually in Macrolon cages (Type 3)
- Diet: standard guinea pig pellets - NAFAG No. 845, Gossau SG ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+3
- Humidity (%): 30 to 70
- Photoperiod (hrs dark / hrs light): 12 h light
- IN-LIFE DATES: From: November 21, 1994 To December 15, 1994
Route:
intradermal
Vehicle:
physiological saline
Concentration / amount:
5 % / 0.1 ml
Day(s)/duration:
Day 0
Adequacy of induction:
highest technically applicable concentration used
Route:
epicutaneous, occlusive
Vehicle:
physiological saline
Concentration / amount:
50 %
Day(s)/duration:
Day 8
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
water
Remarks:
distilled water
Concentration / amount:
0.2 g on 2x2 cm patch
Day(s)/duration:
Day 21
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
The test was performed on a total of 10 males and 10 females guinea pigs in the test group and 5 males and 5 females in the control group, respectively.
Details on study design:
Test procedure
DAY 0: INDUCTION, intradermal injections: Three pairs of intradermal injections (0.1 ml per injection) were made simultaneously into the left and right side of the shaved neck of the test and control group animals.
Test group:
- adjuvant/saline mixture 1:1 (v/v)
- 5 % FAT 40034/E in physiological saline (w/v)
- 5 % FAT 40034/E in the adjuvant/saline mixture (w/v)
Control group:
- adjuvant/saline mixture 1:1 (v/v)
- adjuvant/saline mixture 1:1 (v/v)
- physiological saline

DAY 8: INDUCTION, epidermal application: In the test group FAT 40034/E was incorporated in physiological saline and applied on a filter-paper patch to the neck of the animals (patch 2x4 cm; approx. 0.4 g per patch; occluded administration for 48 hours). The control group was treated with the vehicle only.
Test group:
- 50 % FAT 40034/E in physiological saline
Control group:
- physiological saline only

DAY 21: Challenge
The test and control group animals were tested on one flank with the dyed textile patch moistened with distilled water, (patch 2x2 cm; approx. 0.2 g per patch; occluded administration for 24 hours).

Test and control group:
- dyed textile patch moistened with distilled water.
Challenge controls:
None
Positive control substance(s):
yes
Remarks:
2-Hercaptobenzothiazole puriss.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
30%
No. with + reactions:
2
Total no. in group:
20
Clinical observations:
Erythema observed in 2 animals out of 20.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
30%
No. with + reactions:
2
Total no. in group:
20
Clinical observations:
Erythema observed in 2 animals out of 20.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50%
No. with + reactions:
2
Total no. in group:
20
Clinical observations:
Erythema and edema in 2 animals
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50%
No. with + reactions:
2
Total no. in group:
20
Clinical observations:
Erythema and edema in 2 animals
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
30 and 50%
No. with + reactions:
0
Total no. in group:
20
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
30 and 50%
No. with + reactions:
0
Total no. in group:
20
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
30%
No. with + reactions:
12
Total no. in group:
20
Clinical observations:
Erythema and edema
Remarks on result:
other: Reference values with 2-Hercaptobenzothiazole puriss from Test No. 940015.
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
30%
No. with + reactions:
13
Total no. in group:
20
Clinical observations:
Erythema and edema
Remarks on result:
other: Reference values with 2-Hercaptobenzothiazole puriss from Test No. 940015.
Interpretation of results:
GHS criteria not met
Conclusions:
FAT 40034/E is not considered as a sensitiser to rabbit skin.
Executive summary:

A guinea pig maximisation test was performed to determine the sensitization potential of FAT 40034/E according to the OECD Guideline 406.

Pocedure:

Day 0: Induction: Three pairs of intradermal injections (0.1 ml per injection in physiological saline with 5 % concentration) were made simultaneously into the left and right side of the shaved neck of the test and control group animals.

Day 8: Induction: In the test group FAT 40034/E was incorporated in physiological saline and applied on a filter-paper patch to the neck of the animals (patch 2x4 cm; approx. 0.4 g per patch; occluded administration for 48 h). The control group was treated with the vehicle only. Test Concentration was 50 % FAT 40034/E in physiological saline

Day 21: Challenge: The test and control group animals were tested on one flank with the dyed textile patch moistened with distilled water, (patch 2x2 cm; approx. 0.2 g per patch; occluded administration for 24 h). The dyed textile patch moistened with distilled water.

Following the challenge, 10 % of the animals of the test group showed skin reactions 24 and 48 h after removing the dressings. Based on the study results FAT 40034/E does not meet the criteria for classification according to CLP (1272/2008) Regulation and is not considered as a sensitiser to rabbit skin.

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

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the findings in the skin sensitisation study the Reactive Red 24:1 should not considered to be classified as Skin Sensitiser according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.