Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
May 3 to 10, 1993
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The skin irritation test, performed in the year 1993, did not follow the OECD. However the conditions applied in the study are acceptable and the result shows clearly that the substance is not irritant. 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:
1993
Report Date:
1993

Materials and methods

Principles of method if other than guideline:
The skin test ratings were interpreted according the Council Dir. 83/467/EEC adapting to technical progress for the 50th time the Council Dir. 67/548/EEC.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Breeding "Conelli" - Arona, Italy
- Weight at study initiation: 2,5 - 3,5 kg
- Housing: stainless steel cages of mm 450 x 500 x 380 with automatic washing cycle
- Diet (e.g. ad libitum): pellet complete diet
- Water (e.g. ad libitum): filtered water from local network

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 2 °C
- Humidity (%): 55% +/- 15%
- Air changes (per hr): at least 25 times per hour
- Photoperiod (hrs dark / hrs light): 12 h/day

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
10 cm of area has been designated for the position of the patch. Square gauze pads have been used, secured in place by thin bands of adhesive tape. The entire trunk of the animal has been then wrapped with rubberized cloth.
Duration of treatment / exposure:
4 hours
Observation period:
24, 48, 72 hours and after 5, 7 days
Number of animals:
3 males
Details on study design:
Each animal had a non-treated area and a treated area with test material. Each animal served as its own control.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 5 and 7 days
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 5 and 7 days
Score:
0
Max. score:
0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material "D-Glucopyranose, oligomers, monosulfosuccinate, coco alkyl glycosides, sodium salts", in according with EEC Directives 91/325, can be considered non irritant.