Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
06 Feb - 16 Mar 2006
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Remarks:
missing information on animal husbandry, test site preparation and control group treatment; test substance was not tested up to irritating dose > 60% for epicutaneous induction.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report date:
2006

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
17 July 1992
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Version / remarks:
Commission Directive (EC) No 96/54 dated 30 July 1996
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Agence française de sécurité sanitaire des produits de santé (Afssaps), France
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The test was done before LLNA as first-choice method for in-vivo testing was set into force.

Test material

Constituent 1
Chemical structure
Reference substance name:
Fatty acids C16-18 (even numbered), mono and di esters with Sucrose
EC Number:
947-854-9
Molecular formula:
not applicable, substance is UVCB
IUPAC Name:
Fatty acids C16-18 (even numbered), mono and di esters with Sucrose

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Centre de Production Animale, Olivet, France
- Weight at study initiation: 290 - 391 g
- Diet: guinea pig breeding diet, irradiated
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 30 - 53

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
physiological saline
Concentration / amount:
0.39%
Day(s)/duration:
single injection
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Route:
epicutaneous, open
Vehicle:
physiological saline
Concentration / amount:
60%
Day(s)/duration:
48 h
Adequacy of induction:
other: non-irritant dose, but skin pre-treated with 10% SDS; dose not tested >60% in range finding test
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
physiological saline
Concentration / amount:
7.5% and 15%
Day(s)/duration:
24 h
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
Negative control: 3 males and 3 females
Treatment group: 2 males and 9 females
Details on study design:
RANGE FINDING TEST:
The aim of the range finding test was to find out the highest concentrations which cause mild-to-moderate skin irritation after intracutaneous and epicutaneous administration and the highest non-irritant concentration after epicutaneous administration. For the intracutaneous tolerance test 7 concentrations of the test substance ranging 0.39 - 25% (w/v) in physiological saline were injected in 2 males by intradermal route. No necrosis has been observed with the concentration of 0.39% (w/v) and therefore, this concentration was selected for the intradermal induction phase of the main study. For the epicutaneous tolerance test two males were treated with 4 concentrations of the test substance (7.5, 15, 30 and 60% w/v) in physiological saline. Applications to the skin were made under occlusive dressings for 24 hours. The test substance did not cause any irritating effects, therefore the 60% concentration was chosen for epicutaneous induction. Epicutaneous tolerance for the challenge application was tested after induction by intradermal injection with physiological saline solution and by topical application with distilled water and a 13-day rest phase. The challenge phase consists in a single topical application of the test item under occlusive dressing for 24 hours at the following concentrations: diluted at 7.5, 15, 30 and 60% (w/v) in distilled water. 24 hours after removal of the patches, a slight to moderate erythema in two animals was noted on the treated area at 60% (w/v) and in the three animals on the treated area at 30% (w/v). Therefore, 7.5 and 15% were selected for the challenge application.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous, respectively)
- Exposure period: single injection (intradermal) and 48 h (epicutaneous)
- Test groups:
Intradermal (3 pairs of injections):
Injection 1: 0.39% (w/v) test substance in physiological saline
Injection 2: a 1:1 mixture (v/v) FCA/physiological saline
Injection 3: 0.78% (w/v) test substance in a 1:1 mixture (v/v) FCA/physiological saline
Epicutaneous: 60% (w/v) test substance in physiological saline
- Negative control groups: not further specified
- Site: not specified
- Frequency of applications: 7 days
- Duration: Days 0-8
- Concentrations: intradermal 0.39%, epicutaneous 60%

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Days of challenge: Day 26
- Exposure period: 24 h
- Test and control groups: 7.5 and 15% (w/v) test substance in distilled water
- Site: not specified
- Concentrations: 7.5%, 15%
- Evaluation: 24 and 48 h after challenge patch removal

OTHER:
Because the test substance (60%) was non-irritating after epicutaneous administration during the preliminary study, a pretreatment of the skin with 0.5 mL 10% sodium lauryl sulphate was carried out 24 h before induction by epicutaneous administration.
Body weight was measured on Day 0 and at 48 h reading time point.
Challenge controls:
The control group is actually a challenge control.
Positive control substance(s):
yes
Remarks:
alpha-Hexylcinnamaldehyde

Results and discussion

Positive control results:
The positive control is a historical background data group from three studies performed between Apr 2005 and Jan 2006. The epicutaneous administration of 12.5, 25 and 50% suspensions of a-Hexylcinnamaldehyde caused positive responses in 18 - 100% of the animals. Thus, reliability criteria for the Guinea Pig Maximisation Test is met.

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
Challenge: 15% (w/v)
No. with + reactions:
0
Total no. in group:
6
Clinical observations:
skin dryness in 1/6 animals
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
Challenge: 15% (w/v)
No. with + reactions:
1
Total no. in group:
11
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
Challenge: 15% (w/v)
No. with + reactions:
0
Total no. in group:
6
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
Challenge: 15% (w/v)
No. with + reactions:
0
Total no. in group:
11
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
Challenge: 7.5% (w/v)
No. with + reactions:
0
Total no. in group:
6
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
Challenge: 7.5% (w/v)
No. with + reactions:
0
Total no. in group:
11
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
Challenge: 7.5% (w/v)
No. with + reactions:
0
Total no. in group:
6
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
Challenge: 7.5% (w/v)
No. with + reactions:
0
Total no. in group:
11
Key result
Group:
positive control
Remarks on result:
other: historical data available

Any other information on results incl. tables

Sensitising potential assessment:

In 1/11 animals of the test group (15% w/v) a slight erythema (grade 1) was noted at 24 h reading. No other macroscopic cutaneous reactions attributable to allergy were recorded during the examination following removal of the occlusive dressing after challenge. No cutaneous intolerance reaction was recorded in animals from the negative control group.

Other Observations:

No mortality was noted during this study. A reduction in body weight gain was noted in one animal of control group. No other abnormalities in the weight gain were noted for remaining animals.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
Conclusions:
Under the conditions of the guinea pig maximisation test the test substance revealed no sensitising properties.