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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
publication
Title:
Safety evaluation of some humectants and moisturizers used in cosmetic formulations.
Author:
Guillot JP, Martini MC, Giauffret JY, Gonnet JF, Guyot JY
Year:
1982
Bibliographic source:
International Journal of Cosmetic Science 4: 67-80

Materials and methods

Principles of method if other than guideline:
Draize Test: test procedure as described in the Journal Officiel de la République Francaise.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2,2'-oxydiethanol
EC Number:
203-872-2
EC Name:
2,2'-oxydiethanol
Cas Number:
111-46-6
Molecular formula:
C4H10O3
IUPAC Name:
2,2'-oxydiethanol
Details on test material:
no details given.

Test animals

Species:
rabbit
Strain:
not specified
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: about 2.5 kg
- Housing: in individual cages
- No further details provided

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated skin served for control
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
23 h
Number of animals:
6 males
Details on study design:
TEST SITE
- Area of exposure: 4 cm x 4 cm; application area with and without scarification
- Type of wrap if used: occlusive patches "Neodermotest", fixed using absorbent gauze held in place by adhesive tape.

SCORING SYSTEM: Draize-score system; determination of the primary cutaneous irritation index.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: primary cutaneous irritation index
Basis:
mean
Time point:
other: no data
Score:
0.04
Remarks on result:
other: undiluted DEG
Irritation parameter:
other: mean maximum cutaneous index
Basis:
mean
Time point:
other: 6 weeks
Score:
0.47
Remarks on result:
other: undiluted DEG
Irritation parameter:
other: mean maximum cutaneous index
Basis:
mean
Time point:
other: 6 weeks
Score:
0
Remarks on result:
other: 10% solution
Irritant / corrosive response data:
Undiluted DEG: PII: 0.04; 6 -week cumulative cutaneous irritation: well tolerated (MMII = 0.47)
10% solution: 6 -week cumulation cutaneous irritation: very well tolerated (MMII = 0)

PII = primary cutaneous irritation index;
MMII = mean maximum cutaneous index.

Applicant's summary and conclusion

Interpretation of results:
other: not irritating
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
In their pure form, humectants are particularly well tolerated in primary cutaneous irritation for nearly all these indices approximate to 0 and so correspond to a non-irritant application.