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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
December 1993
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study without detailed documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report date:
1993

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Butanedioic acid, 2,3-dihydroxy- [R-(R*,R*)]-,C12-13-branched alkyl esters
EC Number:
947-004-7
Molecular formula:
C28H56O6 - C29H58O6 - C30H60O6
IUPAC Name:
Butanedioic acid, 2,3-dihydroxy- [R-(R*,R*)]-,C12-13-branched alkyl esters
Test material form:
liquid
Details on test material:
product

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Nossan, Correzzana MI, Italy
- Age at study initiation: no data
- Weight at study initiation: 180 - 200 g
- Fasting period before study: not mentioned
- Housing: in groups of 5 per sex per cage (polycarbonate, dimensions 425x266x180 mm)
- Diet (e.g. ad libitum): standard pellet complete diet ad libitum
- Water (e.g. ad libitum): filtered tap water ad libitum
- Acclimation period: one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +- 2 °C
- Humidity (%): 55% +- 15 % R.H.
- Air changes (per hr): 25
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 17-Nov-1993 To: 01-Dec-1993

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
Treatment
Skin preparation
Approximately 24 hours before the test fur was removed by clipping and shaving a dorsal area about 25 cm2 wide.The patch was removed 24 hours after application.

TEST SITE
- Area of exposure: 25 m2 wide
- % coverage: The sample was put on a patch (Hansamed strips) the dorsal area of animals. The patch was then impermeable and hypoallergenic plastic adhesive 3M)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The exceeding material was then washed away from skin using a pad soaked in distilled water.
- Time after start of exposure: no data



Duration of exposure:
no data
Doses:
2000 m/kg bw at a volume of 10 mL/kg.
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
Mortality: daily in the working week (5 out of 7 days)
Clinical symptoms (including evaluation of body functions, tegumentary apparatus, mucosae conditions, respiratory activity, sensorium conditions): not mentioned
Body weight: before the experiment, at day 7 and 14
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
Male: 2 mL/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2 mL/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
Signs of toxicity related to dose levels: None
Body weight:
Body weight gain was normal during the study
Gross pathology:
During the necropsy in rat female n. 3 a sub-capsular cyst was observed in the right kidney. The anomaly is not ascribable to the treatment.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 dermal in the rat was greater than 2000 mg/kg bw.
Executive summary:

The test of acute dermal toxicity was performed on a group of ten rats (5 male and 5 female) according to EEC Directive 92/69. The test material Butanedioic acid, 2,3-dihydroxy- [R-(R*,R*)]-, C12-13-branched alkyl esters alkyl esters, was administered at a dose of 2000 mg/kg bw by dermal application. During the study no case of mortality occurred. No clinical symptoms were observed, the body weight gain was normal for the used species. The LD50 was greater than 2000 mg/kg bw and Butanedioic acid, 2,3-dihydroxy- [R-(R*,R*)]-, C12-13-branched alkyl esters was found to be non-toxic under experimental conditions.

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