Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
2008-08-06 to 2008-08-20
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Read-across from a guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
1987
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Version / remarks:
1992
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- 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:
- 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) .
Body weight:
The changes noted in body weight gain in males and females were within the range expected for rats used in this type of study and were therefore considered not indicative of toxicity.
Gross pathology:
No abnormalities were found at macroscopic post mortem examination of the animals.

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:
In this study the test substance has a LD50 of > 2000 mg/kg bw.
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.