Registration Dossier
Registration Dossier
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EC number: 943-980-3 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation
- Remarks:
- in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- August 31, 1995
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The sensitisation test, performed in the year 1995, did not follow the OECD. However the conditions applied in the study are acceptable and the result shows that the substance is not sensitising. The alkylpolyglucoside has a carbon chain length range of C10-C14 and C10-16. They are both in the category of the long linear and branched chain alcohols. Key points are that the members share the same structural features, similar metabolic pathways, common mode of ecotoxicological action and common levels and mode of human health related effects. Member of the long chain alcohols are of a low order of toxicity following acute and repeated exposures. The overall toxicological profile of the sub-categories of linear and essentially linear alcohols is qualitatively and quantitatively similar for all end points. Reference: OECD SIDS Long chain alcohols, April 18-21, 2006
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
- Principles of method if other than guideline:
- Kligman Magnusson
- GLP compliance:
- no
- Type of study:
- other: Kligman Magnusson
Test material
- Reference substance name:
- Esterification products of C10-14 (even numbered) alkyl oligomeric glycosides with citric acid, disodium salts
- IUPAC Name:
- Esterification products of C10-14 (even numbered) alkyl oligomeric glycosides with citric acid, disodium salts
- Test material form:
- liquid: viscous
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: 'Nossan' Corezzana (MI)
- Weight at study initiation: 200 - 300 g
- Housing: the animals were caged, in groups of ten, in transparent polycarbonate cages
- Diet (e.g. ad libitum): pellet diet
- Water (e.g. ad libitum): filtered water from an automatic watering system
- Acclimation period: animals were kept in quarantine for one week
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.1 test material
- Day(s)/duration:
- 0 - 6 - 7
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.5
- Day(s)/duration:
- from 21 to 24 day
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 10 animals treated with test material
5 animals treated with distilled water - Details on study design:
- RANGE FINDING TESTS:
MAIN STUDY
A. INDUCTION EXPOSURE
- Test groups: 10 guinea pigs treated with 3 double intradermal injections (Freud complete adjuvant in distilled water 1:1, test material and test material in FCA 1:1) . After 6 days a topical application of 0,5 ml of sodium lauril solfatum 105 was made.
After 7 days the eluated of the test material (dose 0,5 ml/animal) was applied for a period of 48 h.
- Control group: 5 guinea pigs treated with the same pairs of injection but in the 2nd one only distilled water were used. - Challenge controls:
- B. CHALLENGE EXPOSURE
- Day(s) of challenge: 21 days after the beginning of treatment
- Exposure period: 24 h
- Concentrations: 0,5 ml of the test material on the left side and distilled water on the right side
- Evaluation (hr after challenge): 48 and 72 h
Results and discussion
In vivo (non-LLNA)
Results
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5 ml
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.5 ml. No with. + reactions: 0.0. Total no. in groups: 10.0.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Conclusions:
- On the basis of the results the test material can be considered non sensitizing.
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