Registration Dossier

Administrative data

Description of key information

There is no evidence for a skin or eye irritating potential of Stearic acid, esters with methyl α-D-glucoside from a primary dermal irritation study (OECD guideline 404) and an eye irritation study according to OECD guideline 405.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
May 12, 1981
Deviations:
no
GLP compliance:
yes
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.


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.
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
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 %.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

In a primary dermal irritation study according to OECD TG 404, three New Zealand White rabbits 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. 

Comparable effect were observed in a primary dermal irritation study according to OECD Guideline 404 with the read-across substance Isostearic acid, esters with methyl α-D-glucoside. Three young adult male New Zealand White rabbits were dermally exposed to 0.5 g of the test substance for 4 hours, under semi-occlusive dressing and observed for 14 days. Very slight erythema in all three animals was observed after 60 minutes, which had resolved within 24 h in two animals and within 7 days in one animal. In one animal scaliness of treated skin area was noted at 72 hours and 7 days post-treatment and had resolved within 14 days.

Eye irritation:

In a primary eye irritation study according to OECD Guideline 405, 0.1 g of Stearic acid, esters with methyl α-D-glucoside (according to producer information 100 % w/w), was instilled undiluted into the conjunctival sac of one eye of three New Zealand White rabbits. The untreated eye served as control. The eyes were not washed. Animals were then observed for 72 hours. No iridial irritation or corneal opacity was observed. An irritation of the conjunctivae, which consisted of redness and chemosis was observed in one eye of each rabbit within the first hour. The irritation was fully reversible within 24 hours.

 

Similar effects were observed in a primary eye irritation study performed with read across substance in a study according to OECD Guideline 405. 0.1 ml of Isostearic acid, esters with methyl α-D-glucoside, was instilled unchanged into the conjunctival sac of one eye, each of three New Zealand White rabbits. The eyes were not washed. Animals were then observed for 72 hours. No iridial irritation or corneal opacity was observed. An irritation of the conjunctivae, which consisted of redness and chemosis was observed at the first hour reading and was fully reversible within 24 hours.

Respiratory irritation

No inhalation studies have been performed as inhalation is not a relevant exposure path for this substance due to its very low vapour pressure and because no exposure via aerosols has to be assumed at the working place.

Conclusion:

In essence there is no evidence for a skin or eye irritating potential of Stearic acid, esters with methyl α-D-glucoside from the present studies. As well data from the read-across substance Isostearic acid, esters with methyl α-D-glucoside show a very similar irritation profile, only very slight effects were observed in these studies.

This is expected due to the difference in fatty acid moiety whereas the stearic acid is a linear saturated C18 fatty acid and Isostearic acid is branched. In general a branched fatty acid is expected to have a more critical toxicological profile than a linear one. Consequently the Isostearic acid, esters with methyl α-D-glucoside is representing a worst case.


Justification for selection of skin irritation / corrosion endpoint:
Data from GLP compliant in-vivo skin irritation studies according to OECD guideline 404 (RL1) are available for the substance itself and the read-across substance Isostearic acid, esters with methyl α-D-glucoside.

Justification for selection of eye irritation endpoint:
Data from GLP compliant in-vivo eye irritation studies according to OECD guideline 405 (RL1) are available for the substance itself and the read-across substance Isostearic acid, esters with methyl α-D-glucoside.

Justification for classification or non-classification

There is no evidence for a skin or eye irritating potential of Stearic acid, esters with methyl α-D-glucoside from the present studies. According to Directive 67/548/EEC as well as GHS Regulation EC No 1272/2008 Stearic acid, esters with methyl α-D-glucoside has not to be classified or labelled with respect to skin and eye irritation.