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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 2008-03-13 to 2008-04-25
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The reliability is rated 1 because the study followed the standard guideline of reference (OECD 406), which describes a procedure designed to evaluate this endpoint, the results were reviewed for reliability and assessed as valid, and the study was conducted under GLP condition.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report date:
2008

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:
Buehler test

Test material

Constituent 1
Reference substance name:
Bis{tris[4-(mono and dimethylamino)phenyl]methylium} 2-(bis{4-[ethyl(3- sulfonatobenzyl)amino]phenyl}methyliumyl)benzenesulfonate
IUPAC Name:
Bis{tris[4-(mono and dimethylamino)phenyl]methylium} 2-(bis{4-[ethyl(3- sulfonatobenzyl)amino]phenyl}methyliumyl)benzenesulfonate
Constituent 2
Chemical structure
Reference substance name:
Bis{tris[4-(mono and dimethylamino)phenyl]methylium} 2-(bis{4-[ethyl(3-sulfonatobenzyl)amino]phenyl}methyliumyl)benzenesulfonate
EC Number:
700-610-3
Molecular formula:
UVCB substance - not applicable
IUPAC Name:
Bis{tris[4-(mono and dimethylamino)phenyl]methylium} 2-(bis{4-[ethyl(3-sulfonatobenzyl)amino]phenyl}methyliumyl)benzenesulfonate
Details on test material:
- Name of test material (as cited in study report): Sepisol Fast Blue 2BR
- Substance type:organic
- Physical state: blue powder
- Lot/batch No.: 905536
- Storage condition of test material: normal temperature and in the dark

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: S.C.E.A du Peycher (24610 Villefranche, France)
- Weight at study initiation: 358.6 to 439.0
- Housing: Singly housed, in polypropylene cage (31 cm x 46 cm x 19 cm) with a stainless steel lid. Dust-free sawdust litter.
- Diet: granules 106 (supplied by SAFE (89290 Augy, France))
- Water:ad libitum. Distributed by a polypropylene biberon with a stainless steel teat.
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2°C
- Humidity (%): 50 +/- 20%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
olive oil
Concentration / amount:
Induction exposure : 60% of the test material in olive oil.
Challenge exposure: 60% and 30% of the test material in olive oil.
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
olive oil
Concentration / amount:
Induction exposure : 60% of the test material in olive oil.
Challenge exposure: 60% and 30% of the test material in olive oil.
No. of animals per dose:
2 animals for the pilot study (to determine the highest mild irritating dose and the highest non-irritating dose)
20 animals for the test group
10 animals for the control group
Details on study design:
RANGE FINDING TESTS:
2 animals were used.
The highest dose tested was 60% in olive oil, which was determined to be the maximal non-irritating concentration for both the induction and the challenge exposure. For the challenge exposure, a second concentration, named "safety concentration" was derived by dividing the 60% in olive oil dose by 2.


MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 2 weeks for the test group
- Test groups: 20
- Control group: 10
- Site: scapular area
- Frequency of applications: Days 1, 8 and 15
- Duration: 6 hours +/- 10 min
- Concentrations: 60 %

B. CHALLENGE EXPOSURE
- No. of exposures:1
- Day(s) of challenge: on the 29th day
- Exposure period: 6hrs +/- 10 min for both the test and the control group.
- Site: lombar dorsal area
- Test groups: 0.50 mL of the test item at the maximum non-irritating concentration (60%) and at half maximum non-irritating concentration (30%)
- Control group: 0.50 mL of the vehicle
- Concentrations:30% and 60%
- Evaluation (hr after challenge): 1 day and 2 days after removal of challenge exposure

Challenge controls:
10 male animals used as control group. They were untreated during the induction phase
Positive control substance(s):
yes
Remarks:
alpha-hexylcinnamaldehyde

Study design: in vivo (LLNA)

Concentration:
-
No. of animals per dose:
-
Details on study design:
-
Statistics:
-

Results and discussion

Positive control results:
-

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
na
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: na.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
na
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: na.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
60 and 30 %
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
na
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 60 and 30 %. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: na.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
60 and 30%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
na
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 60 and 30%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: na.

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Remarks on result:
other: -
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: -

Any other information on results incl. tables

Maximal irritating concentration was determined to be 60 % in olive oil

Maximum Non-irritating Concentration was determined to be 60 % in olive oil.

(No maximum irritating concentration was determined so the maximum non-irritating concentration was used).

vehicle : olive oil

Groups

Animals Number

Skin reaction as a function of concentration and time reading

60 %

30 %

Vehicule

CWA

24 hr

48 hr

24 hr

48 hr

24 hr

48 hr

24 hr

48 hr

Control Group

From 3869 up to 3878

0

0

0

0

0

0

0

0

% reactive animals

0

0

0

0

0

0

0

0

Treated group

From 3879 up to 3898

0

0

0

0

0

0

0

0

% reactive animals

0

0

0

0

0

0

0

0

0: no visible modification

CWA: control wiping acetone

Weight of a animals were recorded for controls and tested groups. No differences was noticed

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test element at the concentration of 60 % in olive oil was not classified among the chemicals which may cause sensitization by skin contact.
Executive summary:

The aim of the study was to assess, in 30 guinea-pigs, the skin sensitisation potential of the test element under occlusive patch. The 20 treated animals were exposed 3 times to the test element by epidermal application at the concentration of 60% with olive oil. Concurrently, the 10 control animals received olive oil by epidermal application. Following a rest period of 14 days ending the induction period, all the animals were exposed to the challenge dose of 60 % of the test item with olive oil and the security dose of 30%.

The extent, degree and duration of skin reaction to the challenge exposure in the test animals were compared with those demonstrated by control animals.

The test element at the concentration of 60 % in olive oil was not classified among the chemicals which may cause sensitization by skin contact in accordance with the regulation 1272/2008.