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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2010-06-16 - 2010-06-30
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and guideline compliant study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
1987
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Fatty acids, safflower-oil, Et esters
EC Number:
293-106-3
EC Name:
Fatty acids, safflower-oil, Et esters
Cas Number:
91051-53-5
IUPAC Name:
Fatty acids, safflower-oil, Et esters
Test material form:
other: liquid

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. 10 weeks
- Fasting period before study: no
- Housing: Individually housed in labelled Makrolon cages
- Diet: ad libitum (SM R/M-Z from SSNIFF® Spezialdiaten GmbH, Soest, Germany)
- Water: ad libitum (tap water)
- Acclimation period: at least 5 days before treatment

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.0 ± 3.0
- Humidity (%): 39 - 75
- 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
- Area of exposure: back of the animals (males: 25 cm2; females: 18 cm2), 10% of the total body surface
- Type of wrap if used: surgical gauze patch successively covered with aluminum foil and Coban elastic bandage

REMOVAL OF TEST SUBSTANCE
- Washing: with tap water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.27 mL/kg bw
- Constant concentration used: yes
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: twice daily (viability), once daily (clinical signs), on day 1, 8 and 15 (body weights)
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred.
Clinical signs:
Chromodacryorrhea was shown by two animals on Day 1. Other clinical signs were not noted In any of the animals. The application site did not display any signs of skin irritation.
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: EU
Conclusions:
The acute dermal median lethal dose (LD50) of the test item exceeds 2000 mg/kg bw.
Executive summary:

The acute dermal toxicity study was carried out on the basis of OECD No. 402.

The test substance was dermally admnistered to five Wistar rats of each sex by a single application of 2000 mg/kg bw for 24 h. Animals were subjected to daily observations and weekly determinations of body weight. Macroscopic examination was performed after terminal sacrifice (day 15).

No mortality occurred. Chromodacryorrhoea was shown by two animals on day 1. Other clinical signs were not noted in any of the animals. The application site did not display any signs of irritation. The body weight gain during the observation period was within the the expected range. No abnormalities were found at macroscopic post mortem examination of the animals.

The acute dermal median lethal dose (LD50) of the test item exceeds 2000 mg/kg bw.