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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2001-06-21 to 2001-07-05
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report date:
2000

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
ZINN(II)-RICINOLEAT
IUPAC Name:
ZINN(II)-RICINOLEAT
Constituent 2
Reference substance name:
Reaction products of ricinoleic acid and linoleic acid and oleic acid with sodium hydroxide and tin (II) chloride
EC Number:
700-814-2
Molecular formula:
not applicable UVCB substance
IUPAC Name:
Reaction products of ricinoleic acid and linoleic acid and oleic acid with sodium hydroxide and tin (II) chloride
Test material form:
liquid: viscous

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
Species : Rat, Wistar strain Crl:(WI) BR (outbred, SPF-Quality). Recognised by international guidelines as the recommended test system (e.g. OECD, EC).
Source : Charles River Deutschland, Sulzfeld, Germany.
Number of animals : 6 Animals. Each dose group consisted of 3 animals of one sex (females were nulliparous and non-pregnant).
Age and body weight : Young adult animals (approx. 8 weeks old) were selected. Body weight variation did not exceed +/- 20% of the sex mean.
Identification : Earmark.
Conditions : A controlled environment was maintained in the room with optimal conditions considered as being approximately 15 air changes per hour, a temperature of 21°C, a relative humidity of 50% and 12 hours artificial fluorescent light and 12 hours dark per day. Deviations from these optimal conditions were noted, but were considered not to have affected study integrity.
Accommodation : Group housing of 3 animals per sex per cage in labelled polycarbonate cages containing purified sawdust as bedding material (SAWI, Jelu Werk, Rosenberg, Germany). Certificates of analysis were examined and then retained in the NOTOX archives. Acclimatisation period was at least 5 days before start of treatment under laboratory conditions.
Diet : Free access to standard pelleted laboratory animal diet (from Carfil Quality BVBA, OudTurnhout, Belgium). Certificates of analysis were examined and then retained in the NOTOX archives.
Water : Free access to tap-water. Certificates of quarterly analysis were examined and then retained in the NOTOX archives.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
A health inspection was performed prior to commencement of treatment, to ensure that the animals were in a good state of health.
Method : Oral gavage, using a stainless steel stomach tube.
Fasting : Food was withheld overnight (for a maximum of 20 hours) prior to dosing until approximately 3-4 hours after administration of the test substance.
Frequency : Single dosage, on day 1.
Dose level (volume) : 2000 mg/kg (1.67 mllkg) body weight. Dose volume calculated as dose level: specific gravity.
Doses:
2000 mg/kg bodyweight
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration : 14 days
- Necropsy of survivors performed : yes
- Mortality/Viability : Twice daily.
- Body weights : Days 1 (pre-administration), 8 and 15.
- Clinical signs : At periodic intervals on the day of dosing (day 1) and once daily thereafter, until day 15. The symptoms were graded according to fixed scales and the time of onset, degree and duration were recorded: Maximum grade 4: grading slight (1) to very severe (4) Maximum grade 3: grading slight (1) to severe (3) Maximum grade 1: presence is scored (1).
- Necropsy : At the end of the observation period, all animals were sacrificed by asphyxiation using an oxygen/carbon dioxide procedure and subjected to necropsy. Descriptions of all internal macroscopic abnormalities were recorded. All animals assigned to the study were subjected to necropsy and descriptions of all internal macroscopic abnormalities recorded.
Statistics:
The test substance was ranked within LDso value ranges of 0-25, 25-200, 200-2000 or exceeding 2000 mg/kg body weight. No statistical analysis was performed (The method used is not intended to allow the calculation of a precise LD50 value). The results were evaluated according to the EC criteria for classification and labelling requirements for dangerous substances and preparations (Guidelines in Commission Directive 93/21/EEC).

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:
other: No clinical signs were noted.
Gross pathology:
No abnormalities were found at macroscopic post mortem examination of the animals.

Any other information on results incl. tables

BODY WEIGHTS (GRAM)

Group / Sex

Animal

Day 1

Day 8

Day 15

Group 1 / Females

1

193

228

230

2000 mg/kg

2

175

207

208

 

3

198

234

240

 

Mean

189

223

226

 

ST. DEV.

12

14

16

 

N

3

3

3

Group 2 / Males

4

308

374

422

2000 mg/kg

5

294

343

384

 

6

292

347

382

 

Mean

298

355

396

 

ST. DEV.

9

17

23

 

N

3

3

3

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:
The oral LDso value of ZINN(II)-RICINOLEAT in Wistar rats was established to exceed 2000 mg/kg body weight.
Executive summary:

Assessment of acute oral toxicity with ZINN(II)-RICINOLEAT in the rat (Acute Toxic Class Method).

The study was carried out based on the guidelines described in: EC Commission Directive 96/54/EC, Part B.1 tris "Acute Toxicity-Oral, Acute Toxic Class Method" and OECD No.423, "Acute Oral Toxicity - Acute Toxic Class Method". ZINN(II)-RICINOLEAT was administered by oral gavage to three Wistar rats of each sex at 2000 mg/kg body weight. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (day 15). No mortality occurred. No clinical signs were noted. The body weight gain shown by the animals over the study period was considered to be normal. No abnormalities were found at macroscopic post mortem examination of the animals. The oral LD50 value of ZINN(II)-RICINOLEAT in Wistar rats was established to exceed 2000 mg/kg body weight.