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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:
18 April 1994 to 5 July 1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
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.

Test material

Constituent 1
Reference substance name:
Disodium 6-amino-5-[{4-[(2-bromoacryloyl)amino]-2-[(4-methyl-3-sulfonatophenyl)sulfonyl]phenyl}diazenyl]naphthalene-2-sulfonate
Cas Number:
85187-33-3
Molecular formula:
C26H19BrN4Na2O9S3
IUPAC Name:
Disodium 6-amino-5-[{4-[(2-bromoacryloyl)amino]-2-[(4-methyl-3-sulfonatophenyl)sulfonyl]phenyl}diazenyl]naphthalene-2-sulfonate
Test material form:
solid: particulate/powder
Details on test material:
Identity - FAT 40066/E TE
Batch - SBL009/LR6G (India)
Appearance - brown powder, solid at 20 °C
Smell - neutral
pH-Value - pH-value of a soln. of 2% (w/w) = 5.2
Expiration date - December 18th, 2018
Storage - to be stored at room-temperature
Specific details on test material used for the study:
- Source and lot/batch number of test material: P.04.36
- Expiration date of the lot/batch: 11/98
- Appearance: Solid
- Storage conditions: room temperature

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Pirbright White Strain (Tif: DHP)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: CIBA-GEIGY Limited Animal Production 4332 Stein / Switzerland
- Age at study initiation: no data
- Weight at study initiation: 346 to 425 g
- Housing: individually in Macrolon cages (Type 3)
- Diet: guinea pig pellets - NAFAG No. 845, Gossau SG ad libitum
- Water: fresh water ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 to 70
- Photoperiod (hrs dark / hrs light): 12 hours light cycle day

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
propylene glycol
Concentration / amount:
- 5 % FAT 40066/C in 20 % propylene glycol (w/v) with 0.1 ml per injection
Day(s)/duration:
Day 1
Adequacy of induction:
highest technically applicable concentration used
Route:
epicutaneous, occlusive
Vehicle:
other: vaseline
Concentration / amount:
50 % FAT 40066/C in vaseline and applied on a filterpaper patch to the neck of the animals (patch 2x4 cm; approx. 0.4 g per patch
Day(s)/duration:
Day 8
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
other: vaseline
Concentration / amount:
5 % FAT 40066/C in vaseline and on the other flank with the vehicle alone (patch 2x2 cm; approx. 0.2 g per patch
Day(s)/duration:
Day 21
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
5 male and 5 female guinea pigs in the test group and
5 female guinea pigs in the control group
Challenge controls:
Vaseline
Positive control substance(s):
yes
Remarks:
2-Mercaptobenzothiazole puriss

Results and discussion

Positive control results:
All 20 animals treated with 2-Mercaptobenzothiazole puriss were showed reactions ctions after epidermal challenge application.

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
5 % test substance in 20 % vehicle
No. with + reactions:
10
Total no. in group:
10
Clinical observations:
Erythema and Edema
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
5 % test substance in 20 % vehicle
No. with + reactions:
10
Total no. in group:
10
Clinical observations:
Erythema and Edema
Remarks on result:
positive indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
vehicle only
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
vehicle only
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
5 % in Oleum arachidis
No. with + reactions:
20
Total no. in group:
20
Clinical observations:
Etythema and edema
Remarks on result:
positive indication of skin sensitisation
Remarks:
2-Mercaptobenzothiazole puriss
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
5 % in Oleum arachidis
No. with + reactions:
20
Total no. in group:
20
Clinical observations:
Erythema and edema
Remarks on result:
positive indication of skin sensitisation
Remarks:
2-Mercaptobenzothiazole puriss

Any other information on results incl. tables

Body weights were not affected by treatment. Under the experimental conditions employed, 100 % of the animals of the test group showed skin reactions 24 and 48 hours after removing the dressings. Therefore, FAT 40066/C is classified as an extreme sensitiser in albino guinea pigs.

Applicant's summary and conclusion

Interpretation of results:
Category 1B (indication of skin sensitising potential) based on GHS criteria
Conclusions:
FAT 40066/C is considered as a skin sensitiser.
Executive summary:

A study was performed to assess the allergenic potential of FAT 40066/C in albino guinea pigs according to OECD guideline 406. Ten animals (5 males, 5 females) were used as control group and 20 animals (10 males, 10 females) were used as test group. In pretest with 5 % concentration of test substance did not induce erythema reactions. In main test, on Day 0, three intradermal injections (5 % and 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. On Day 8, the application site of all animals was pretreated with 10 % sodium-laurylsul fate (open application) 24 hours prior to the epidermal induction application. In the test group 50 % FAT 40066/C was incorporated in Vaseline (w/w) 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. While the test and control group animals were challenged with 50 % FAT 40066/C in Vaseline (w/w) and on the other flank with the vehicle alone (patch 2x2 cm; approx. 0.2 g per patch; occluded administration for 24 hours). Under the experimental conditions employed, 100 % of the animals of the test group showed skin reactions (erythema and edema) 24 and 48 hours after removing the dressings. So, based on the study results, FAT 40066/C is considered as Skin sensitiser.

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