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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 2008/05/01
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
Chemical structure
Reference substance name:
bis(bis[4-(dimethylamino)phenyl][4-(methylamino)phenyl]methylium) bis(tris[4-(dimethylamino)phenyl]methylium) 3-(dodecan-3-yl)-4-(2-dodecyl-4-sulfonatophenoxy)benzene-1-sulfonate 3-dodecyl-4-(4-sulfonatophenoxy)benzene-1-sulfonate
EC Number:
700-759-4
Molecular formula:
not applicable
IUPAC Name:
bis(bis[4-(dimethylamino)phenyl][4-(methylamino)phenyl]methylium) bis(tris[4-(dimethylamino)phenyl]methylium) 3-(dodecan-3-yl)-4-(2-dodecyl-4-sulfonatophenoxy)benzene-1-sulfonate 3-dodecyl-4-(4-sulfonatophenoxy)benzene-1-sulfonate
Details on test material:
- Name of test material (as cited in study report): Sepisol Fast Violet 881239
- Substance type: organic salt - UVCB
- Physical state: violet powder
- Lot/batch No.: 601204
- 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: From 364.2 to 420.3 for the treated group and from 371.6 to 416.1 for the control group.
- 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
- Concentrations: 60 %

B. CHALLENGE EXPOSURE
- No. of exposures:1
- Day(s) of challenge: on the 29th day
- Exposure period: 6hrs 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 the 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 (CAS No. 101-86-0)

Results and discussion

Positive control results:
The alpha-hexylcinnamaldehyde (CAS 101 -86 -0) was used to assess the sensitivity and the reliability of the method of the study (from 2008/02/04 to 2008/03/05), with a :
- maximal irritating concentration of 100 % (pure).
- safety concentration of 50% (olive oil, acetone).

The percentage of reactive animals was 50%.

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.

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 3950 up to 3959

0

0

0

0

0

0

0

0

% reactive animals

0

0

0

0

0

0

0

0

Treated group

From 3960 up to 3979

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 difference 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 non irritant challenge of 60 % with olive oil.

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 percent of reactive treated and control animals was 0%.

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 percentage of reactive animals according to the defined criteria defined in the decree of 20/04/1994 published in the official journal of the french republic of May 08, 1994 taken in enforcement from the basic Directive 67/548/EEC and its successive amendments.