Registration Dossier
Registration Dossier
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EC number: 943-149-5 | CAS number: -
Skin sensitisation
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:
- 1 989
- 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
- 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
Constituent 1
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.
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