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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
Study period:
1990-08-20 to 1990-08-23
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: - Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
May 12, 1981
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: no data
- Weight at study initiation: 2.4 - 2.8 kg
- Housing: individual housing (50 x 45 x 40 cm, L x B x H) in a battery of cages, each equipped with a paper roll disposal system
- Diet: ad libitum, SsniffMÜZ (Alleindiät für Zuchtkaninchen), Ssniff Spezialdiäten GmbH, Soest/Westfalen, Germany
- Water: ad libitum, drinking water as for human consumption
- Acclimation period: at least 7 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18±2
- Humidity (%): 50 - 85 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): artificial lighting (120 lux) from 7.00 a.m. - 7.00 p.m.


Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: adjacent area of untreated skin
Amount / concentration applied:
TEST MATERIAL
- The test article was applied undiluted.
- Amount(s) applied (volume or weight with unit): 0.5 ml
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
3
Details on study design:
TEST SITE
- 24 h before treatment, fur was removed with electric clippers from an area of roughly 8 x 15 cm on the back of each animal. In each animal, 0.5 ml of the test article were applied to the test site (ca. 6 cm2 in size)
- Area of exposure: back, 6 cm2 in size
- Type of wrap if used: semi-occlusive dressing consisting of Kosmoplast (Medilog), which was held in place by non-irritating tape Elastoplast (Beiersdorf AG, Hamburg), and Stülpa (Hartmann AG, Heidenheim/Brenz).


REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, any residual sample was washed away with water or an appropriate solvent.
- Time after start of exposure: after 4 h


SCORING SYSTEM:
- Dermal irritation was graded according to the EEC directive 83/467/EEC from July 29, 1983 and to GefStoffV, 1987(BGBI. I. p. 2721), as stipulated by OECD TG 404.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: #1, #2, #3
Time point:
other: mean 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal: #1, #2, #3
Time point:
other: mean 24, 48, 72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
- No erythema and edema reactions after 30-60 min, 24 , 48 and 72 hours on control and treated skin area.
Other effects:
- No effects

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No 1272/2008)
Conclusions:
Based on the results of this study the test substance Stearic acid, esters with methyl α-D-glucoside is not irritating to skin.
Executive summary:

In a primary dermal irritation study according to OECD TG 404, three New Zealand Whiterabbits were dermally exposed to 0.5 ml of Stearic acid, esters with methyl α-D-glucoside, undiluted as delivered by the sponsor. The test substance was applied for 4 hours to intact shaved body surface areas under semi-occlusive dressing. Animals then were observed for 72 hours. Irritation was scored by the method described in OECD Guideline 404.

No erythema and edema was observed after 30-60 min, 24, 48 and 72 hours. 

In this study Stearic acid, esters with methyl α-D-glucoside is not a dermal irritant.

Content of a.i. in Stearic acid, esters with methyl α-D-glucoside according to producer’s information: 100 %.