Sulfonation products of dipotassium sulfite with (esterification products of C9-11 (branched and linear) Alkyl Polyglycosides with maleic anhydride)

Skin sensitisation

Administrative data

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. 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:

1995

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

Test material information

Constituent 1

Reference substance name:

D-Glucopyranose, oligomers, monosulfosuccinate, coco alkyl glycosides, sodium salts

EC Number:

500-331-5

EC Name:

D-Glucopyranose, oligomers, monosulfosuccinate, coco alkyl glycosides, sodium salts

Cas Number:

151911-53-4

IUPAC Name:

151911-53-4

In vivo test system

Test animals

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

Study design: in vivo (non-LLNA)

Induction

Route:

intradermal and epicutaneous

Vehicle:

unchanged (no vehicle)

Challenge

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

Results and discussion

In vivo (non-LLNA)

Results

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

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.