reaction mass of sodium acetate, monoethylene glycol and diethylene glycol

Skin irritation / corrosion

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

Test material information

Constituent 1

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

Results

Results 1

Irritation parameter:

other: primary cutaneous irritation index

Basis:

mean

Time point:

other: no data

Score:

0.04

Remarks on result:

other: undiluted DEG

Results 2

Irritation parameter:

other: mean maximum cutaneous index

Basis:

mean

Time point:

other: 6 weeks

Score:

0.47

Remarks on result:

other: undiluted DEG

Results 3

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.