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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment

Data source

Referenceopen allclose all

Reference Type:
other: unpublished report data in secondary source
Title:
Primary skin irritation and eye irritation tests with lactitol in albino rabbits
Author:
van Beek L et al.
Year:
1980
Bibliographic source:
CIVO‐TNO, submitted by CCA to WHO
Reference Type:
other: Published secondary source
Title:
Lactitol
Author:
WHO/FAO
Year:
1983
Bibliographic source:
WHO/FAO: Expert Committee on Food Additives Summary of Toxicological Data of Certain Food Additives Series 18 (http://www.inchem.org/documents/jecfa/jecmono/v18je10.htm)

Materials and methods

Principles of method if other than guideline:
Results of skin irritation study in rabbits are reported.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
4-O-β-D-galactopyranosyl-D-glucitol
EC Number:
209-566-5
EC Name:
4-O-β-D-galactopyranosyl-D-glucitol
Cas Number:
585-86-4
Molecular formula:
C12H24O11
IUPAC Name:
4-O-beta-D-galactopyranosyl-D-glucitol

Test animals

Species:
rabbit
Strain:
not specified

Test system

Type of coverage:
not specified
Preparation of test site:
other: intact and abraded
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
not reported
Observation period:
not reported
Number of animals:
6

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
other: all animals
Time point:
24 h
Remarks on result:
other: erythema was observed on abraded skin of 6 rabbits
Irritation parameter:
edema score
Basis:
other: all animals
Time point:
24 h
Remarks on result:
other: very slight oedema was observed on abraded skin of 6 rabbits
Irritation parameter:
edema score
Basis:
other: all animals
Time point:
other: not specified
Remarks on result:
other: very slight oedema in 2 of 6 rabbits on intact skin
Irritation parameter:
erythema score
Basis:
other: all animals
Time point:
48 h
Remarks on result:
other: not reported
Irritation parameter:
erythema score
Basis:
other: all animals
Time point:
72 h
Remarks on result:
other: not reported
Irritation parameter:
edema score
Basis:
other: all animals
Time point:
48 h
Remarks on result:
other: not reported
Irritation parameter:
edema score
Basis:
other: all animals
Time point:
72 h
Remarks on result:
other: not reported

Applicant's summary and conclusion

Conclusions:
Very slight oedema in 2 of 6 rabbits on intact skin. At 24 hours, erythema and very slight oedema in 6 rabbits on abraded skin.
Executive summary:

A Draize test was conducted with six rabbits, using intact and abraded skin. 0.5 g of the test substance caused a very slight oedema in 2 of 6 rabbits on intact skin. At 24 hours, erythema and very slight oedema were observed on abraded skin-test sites in 6 rabbits.