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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:
July to September 1989
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study without detailed documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Chemical structure
Reference substance name:
Sucrose, glycerol and propane-1,2-diol, reaction products with C16-18(even numbered) fatty acids
Molecular formula:
Representative, generic structures are given in "structural formula" wherein R = H or fatty acid residue and R' = sucrose residue, glycerol residue, H or alkali. Additional citric acid resp. its salt is present.
IUPAC Name:
Sucrose, glycerol and propane-1,2-diol, reaction products with C16-18(even numbered) fatty acids
Test material form:
solid: compact

In vivo test system

Test animals

Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Firma Winkelmann Versuchstierzucht, D-4799 Borchen
- Age at study initiation:
- Weight at study initiation: 285 - 355 g
- Housing: Macrolon plastic cages IV, max 5 animals in one cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days at least

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18°C +- 2°C
- Humidity (%): 50 - 85 %
- Air changes (per hr):-
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
water
Concentration / amount:
Induction intradermal: 10 % in Aqua deion.
Induction epicutaneous: 100 % (undiluted)
Challenge: 100 % (undiluted)
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
Induction intradermal: 10 % in Aqua deion.
Induction epicutaneous: 100 % (undiluted)
Challenge: 100 % (undiluted)
No. of animals per dose:
20 (10 male + 10 female)
Details on study design:
RANGE FINDING TESTS: to exclude skin irritations two animals/group were treated dermally in a preliminary study under occlusive conditions for 24 hours with the following concentrations. 100 % (undiluted) and 10 % in Aqua deion.

MAIN STUDY
A. INDUCTION EXPOSURE
Intradermal treatment (on first day)

- Test groups:
1. 0.1 mL FCA in aqua deion.; 2 (by pairs)
2. 0.1 mL test article (10 %) in aqua deion.; 2 (by pairs)
3. 0.1 mL test article (10 %) in FCA 1:2; 2 (by pairs)

- Control group:
1. 0.1 mL FCA (diluted 1 : 2 in water); 2 (by pairs)
2. 0.1 mL aquq deion.; 2 (by pairs)
3. 0.1 mL aqua deion. (diluted 1 : 2 with FCA); 2 (by pairs)


First dermal treatment (after 7 days)
- Volume: 0.5 mL
- Exposure period: 48 h
- Test groups: 20
- Control group: 20
- Site: first injection were located at the craniodorsal area and the following onces were performed underneath
- Frequency of applications: 1
- Concentrations: 100% (undiluted)

B. CHALLENGE EXPOSURE (after 22 days)
- No. of exposures: 1
- Day(s) of challenge: 3 weeks after the first intradermal treatment
- Exposure period: 24 h
- Control group: aqua deion.
- Concentrations: 100% (undiluted)
- Evaluation (hr after challenge): 24 h, 48 h
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
100 % (undiluted)
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no observations
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100 % (undiluted). No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no observations.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
100 % (undiluted)
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no observations
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100 % (undiluted). No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no observations.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0 %
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no observations
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no observations.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0 %
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no observations
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no observations.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In the study performed according to the method of B. Magnusson and A. M Kligman (OECD guideline 406) the test substance GRILLOTEN PSE 141 G BATCH 901 is considered to cause no contact hypersensitivity. According to CLP, EU GHS (Regulation (EC) No 1272/2008) and to DSD (Directive 67/548/EEC), no classification and labelling is required.
Executive summary:

In a dermal sensitisation study performed according to the OECD Guideline 406 (Skin Sensitisation) with Grilloten PSE 141 G in water, young adult Pirbrightwhite Guinea Pigs 10/sex were tested using the method of B. Magnusson and A. M Kligman. No positive control data are reported.

No skin reactions were observed in the range finding study or in the main study.

In this study, Grilloten PSE 141 G BATCH 901 is not a dermal sensitiser.