D-pentose and D-glucose, oligomeric, C8 and C10 alkyl glycosides

Eye irritation

Administrative data

Endpoint:

eye irritation

Remarks:

other: Category approach based on 11 OECD-405 and 2 OECD-437 studies.

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Category is coherent for more than 10 endpoints. Eye irritation was assessed using 11 OECD-405 studies and 2 OECD-437 studies.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Materials and methods

Principles of method if other than guideline:

Specific category approach based notably on cornea score and reversibility, see report.

GLP compliance:

no

Remarks:

Not relevant for category approach.

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

483-960-7

EC Name:

-

IUPAC Name:

D-pentose and D-glucose, oligomeric, C8 and C10 alkyl glycosides

Results and discussion

In vivo

Results

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

other: 3 days

Score:

ca. 3

Max. score:

4

Reversibility:

not fully reversible within: 21 days

Remarks on result:

other: After 21 days, mean cornea score is 0.3.

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye)

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on 11 OECD-405 and 2 OECD-437 studies, APP with short alkyl chain appear as borderline between eye irritation/damage cat. 2 and 1. Strict application of CLP rules drive a classification 1, as this classification may be very conservative, an SCL is proposed.