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Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation
Remarks:
in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
July 10 - August 4, 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. Eucarol AGE SS (D-Glucopyranose, oligomeric, 6-(hydrogen 2-sulfobutanedioate), 1- (coco alkyl) ethers, sodium salts ) was used as supporting substance due to the structural analogy. The alkylpolyglucoside has a carbon chain length range of C10-C14. 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
Principles of method if other than guideline:
Kligman Magnusson
GLP compliance:
no
Type of study:
other: Kligman Magnusson
Species:
guinea pig
Strain:
Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Padre Antonio - Mariano Comense (CO)
- 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

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/- 2 °C
- Humidity (%): 55% +/- 15%
- Air changes (per hr): at least 25 times per hour
- Photoperiod (hrs dark / hrs light): 12 h/day
Route:
intradermal and epicutaneous
Vehicle:
unchanged (no vehicle)
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
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.

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

Reading:
1st reading
Hours after challenge:
48
Group:
test group
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.
Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
On the basis of the results the test material can be considered non sensitizing.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

The skin sensitisation study was performed in the year 1995 and it did not follow the OECD guidelines. However the conditions applied in the study are acceptable and the result shows that the substance is not sensitising.


Migrated from Short description of key information:
The sensitisation test used for read-across was performed on a structural analogue .
The study was performed according the Kligman Magnusson method; it did not follow the OECD guideline and GLP conditions.

Justification for selection of skin sensitisation endpoint:
The study refers to "D-Glucopyranose, oligomers, monosulfosuccinate, coco alkyl glycosides, sodium salts", a structurally related substance to "Sulfonation products of (esterification products of C9-11 (branched and linear) alkyl-(mono-, di- and tri-)glycosides with maleic anhydride) with disodium sulfite". The skin sensitisation study was performed in the year 1995 and it did not follow the OECD. However the conditions applied in the study are acceptable and the result shows that the substance is not sensitising.

Justification for classification or non-classification

Basing on the skin sensitisation test result and following the REGULATION (EC) No 1272/2008 (EU Regulation on Classification, Labelling and Packaging of substances and mixtures) the substance "Sulfonation products of (esterification products of C9-11 (branched and linear) alkyl-(mono-, di- and tri-)glycosides with maleic anhydride) with disodium sulfite" does not need to be classified as sensitizer.

 

Skin sensitisation: not classified

Hazard statement: none