Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 938-754-6 | 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:
- 01-08-1989 to 03-09-1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
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 and glycerol, reaction products with C12-18, C18unsatd. 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 and glycerol, reaction products with C12-18, C18unsatd. fatty acids
- Test material form:
- semi-solid (amorphous): gel
- Remarks:
- migrated information: paste
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Substrain: Bor: DHPW (SPF), white
- Age at study initiation: no data
- Weight at study initiation: 271 - 350 g
- Housing: max. 5 animals in one cage, Macrolon plastic cages IV: 20 cm high, 33 cm width, 55 cm length
- Diet: ad libitum; Ssniff-G (Alleindiät für Meerschweinchen), pellets
- Water: ad libitum; Macrolon drinking bottles, 300 mI, Fa. Becker & Co., 4629 Castrop-Rauxel
- Acclimation period: 7 days at least
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 2
- Humidity (%): 50-85
- Air changes (per hr): no data
- Photoperiod: 12/12 , Fluorescent light, 120 lux
IN-LIFE DATES: From: 01.08 1989 To: 03.09.1989
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- Range finding study:
Dermal treatment: 10%, 25%, 50%, 100% in water
Main study:
Intradermal treatment: 10 % in water and 10% in 10 % Freund's Adjuvant complete
Dermal treatment: 50 % in water
Challenge: 10 % in water
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Range finding study:
Dermal treatment: 10%, 25%, 50%, 100% in water
Main study:
Intradermal treatment: 10 % in water and 10% in 10 % Freund's Adjuvant complete
Dermal treatment: 50 % in water
Challenge: 10 % in water
- No. of animals per dose:
- Range finding:
2 per dose
Main Study:
10/sex - Details on study design:
- RANGE FINDING TESTS:
To exclude primary skin irritations two animals/group were treated dermally in a preliminary study under occlusiv conditions (exposure period 24 h) with the following concentrations (each 0.5 (g) ml/animal) of the sampie: 100 % (undiluted), 50%, 25% 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: 50% in aqua deion.
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: 10% in Aqua deion.
- Evaluation (hr after challenge): 24 h, 48 h - Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%
- 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: 10%. 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:
- 10%
- 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: 10%. 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: other: CLP, EU GHS (Regulation (EC) No 1272/2008) and DSD (Directive 67/548/EEC)
- Conclusions:
- In the study performed according to the method of B. Magnusson and A. M Kligman (OECDguidelines) the test substance GRILLOTEN LSE 65 K BATCH 801 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 Sucroglyceride C12-18, C18unsatd. in water, young adult Pirbright white 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, Sucroglyceride C12-18, C18unsatd. is not a dermal sensitiser.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
