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Toxicological information

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:
2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of study:
Buehler test
Justification for non-LLNA method:
When the test was performed in 2008, the OECD N°429 (LLNA method) was not adopted yet.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
- Name of test material (as cited in study report): Sepisol fast Blue 85219
- Substance type: organic salt - UVCB
- Appearance/Physical state: dark blue powder
- Stability under test conditions: stable
- Storage condition of test material:room temperature
Specific details on test material used for the study:
- Batch N° 310551

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: less or equal to 500 g
- Housing: 1 animal per cage. Polypropylene cage (31 cm x 46 cm x 19 cm)
- Diet : granules 106 (supplied by SAFE (89290 Augy, France))
- Water : ad libitum
- Acclimation period: at least 5 days

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

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
olive oil
Concentration / amount:
60% of the test material in olive oil
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
olive oil
Concentration / amount:
60% of the test material in olive oil
No. of animals per dose:
20 for the test group
10 for the control group
And 2 animals for determining the maximum non-irritating concentration
Details on study design:
RANGE FINDING TESTS:
2 animals were used.
Maximal irritating concentration was determined to be 60 % in olive oil
Maximum Non-irritating Concentration was determined to be 60 % in olive oil


MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: 29 days
- Test groups: 20
- Control group: 10
- Site: scapular area
- Duration: 6 hours
- Concentrations: 60 %

B. CHALLENGE EXPOSURE
- No. of exposures:1
- Day(s) of challenge: on the 29th day
- Exposure period:2 days
- Site: lombar dorsal area
- Test groups: 0.50 mL of the test item at the maximum non-irritating concentration (60%) et 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

Positive control substance(s):
yes
Remarks:
Alpha-hexylcinnamaldehyde (CAS # 101-86-0)

Results and discussion

Positive control results:
50% of animals were positive with hexylcinnamaldehyde

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
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:
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.

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

vehicle : olive oil

Animal’s number

Skin reaction as a function of time and concentration

60%

30%

15%

7.5%

Vehicle

3824

1h

0

0

0

0

0

24h

0

0

0

0

0

48h

0

0

0

0

0

 

 

 

 

 

 

 

3859

1h

0

0

0

0

0

24h

0

0

0

0

0

48h

0

0

0

0

0

0: no visible modification

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

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
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 sensitisation potential of the test element under occlusive patch.

The assay has been performed according to the OECD guideline N° 406.

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 percentage of reactive control and treated animals was of 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.