Isostearic acid, esters with methyl α-D-glucoside

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2008-08-06 to 2008-08-20

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Version / remarks:

1992

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Version / remarks:

1998

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: JMAFF Guidelines, 2000

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Isostearic acid, esters with methyl α-D-glucoside

EC Number:

700-680-5

Molecular formula:

Molecular formula cannot be given as substance is a mixture.

IUPAC Name:

Isostearic acid, esters with methyl α-D-glucoside

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: approx. 8 weeks
- Weight at study initiation: mean males: 243 g, mean females: 164 g ; variation did not exceed +/- 20 % of the sex mean
- Housing: in a controlled environment, individually housed in Macrolon cages (Mill type, height 18 cm)
- Diet: free access to pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest,Germany)
- Water: ad libitum, tap water
- Acclimation period: at least 5 days before start of treatment

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 3
- Humidity (%): 30 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- One day before exposure (Day -1) an area of approximately 5x7 cm on the back of the animal was clipped.
- Area of exposure: approx. 10 % of the total body surface, i.e, approx. 25 cm2 for males and 18 cm2 for females.
- % coverage: 10 % of body surface
- Type of wrap if used: dressing, consisting of a surgical gauze patch (Surgy 1D), successively covered with aluminum foil and Coban elastic
bandage. A piece of Micropore taps was additionally used for fixation of the bandages in females only.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): skin cleaned of residual test substance using tap water
- Time after start of exposure: 24 h


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg (2.02 ml/kg) body weight. Dose volume calculated as dose level (g/kg) / density (g/ml)
- The test substance was dosed undiluted as delivered by the sponsor.

Duration of exposure:

24 h

Doses:

2000 mg/kg (2.02 ml/kg) body weight.
Dose volume calculated as dose level (g/kg) / density (g/ml)

No. of animals per sex per dose:

5 males, 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: mortality: twice daily; body weight: days 1 (pre-administration), 8 and 15 and at death; clinical signs: at periodic intervals on the day of dosing (day 1) and once daily thereafter, until day 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

No

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

- One male was found dead on day 2. The death of one male on day 2 after treatment was considered to be spontaneous and not treatment related, no macroscopic abnormalities were found at necropsy.

Clinical signs:

other: - Piloerection was noted in all males and two females on day 1. - Scales were seen in the treated skin-area of two females during the observation period (one female at day 4 and 5, the other at day 15, respectively) .

Gross pathology:

No abnormalities were found at macroscopic post mortem examination of the animals.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

In this study the test substance is practically non-toxic.

Executive summary:

In an acute dermal toxicity study according OECD guideline 402, 5 male and 5 female young adult Wistar rats were dermally exposed to Isostearic acid, esters with methyl α-D-glucoside. The test substance was dosed undiluted for 24 hours to 10 % of body surface area at a dose of 2000 mg/kg bw. Animals then were observed for 15 days.

Dermal LD₅₀ males/females > 2000 mg/kg bw (limit test)

There were no treatment related clinical signs, necropsy findings or changes in body weight.

The death of one male on day 2 after treatment was considered to be spontaneous and not treatment related, no macroscopic abnormalities were found at necropsy.

The test substance Isostearic acid, esters with methyl α-D-glucoside is practically non-toxic.