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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2000-07-19 to 2000-08-02
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 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
GLP compliance:
yes
Test type:
standard acute 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 : 5 males and 5 females (females were nulliparous and nonpregnant).
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 : Individually housed 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

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
A health inspection was performed prior to commencement of treatment, to ensure that the animals were in a good state of health. Special attention was paid to the skin to be treated, which was intact and free from any abnormality.
Method : Dermal application.
Clipping : One day before exposure (day -1) an area of approximately 5x7 cm on the back of the animal was clipped.
Application : The test substance was applied in an area of approx. 10% of the total body surface, i.e. approx. 25 cm2 for males and 18 cm2 for
females. The test substance was held in contact with the skin with a dressing, consisting of a surgical gauze patch (Surgy 1 D) *, successively covered with aluminium foil and Coban flexible bandage*. A piece of Micropore tape* was additionally used for fixation of the bandages in females only.
*. Manufacturers: Laboratoires Stella s.a., Liege, Belgium (surgical gauze) and 3M, St. Paul, Minnesota, U.S.A. (Coban & Micropore).
Frequency : Single dosage, on day 1.

Duration of exposure:
Application period : 24 hours, after which dressings were removed and the skin cleaned of residual test substance using water.
Doses:
Dose level (volume) : 2000 mg/kg (1.67 ml/kg) body weight. Dose volume calculated as dose level: specific gravity.
No. of animals per sex per dose:
5
Control animals:
not required
Details on study design:
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 time of onset, degree and duration were recorded and the symptoms graded according to fixed scales: 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.
Statistics:
No statistical analysis was performed.
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: Hunched posture was noted among the females between days 3 and 8. Chromodacryorrhoea* was noted among the animals on days 1 and 2. * Red secretion from the eye that is spread over the body surface by grooming and commonly noted in albino rats. Erythema, s
Gross pathology:
Macroscopic post mortem examination of the surviving animals at termination did not reveal any abnormalities that were not commonly noted among rats of this age and strain or that were considered toxicologically significant.
Other findings:
Incidental findings:
Pelvic dilatation of the kidneys, found in one female, is commonly noted among rats of this age and strain and was therefore considered not toxicologically significant.

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 dermal LD50 value of ZINN(II)-RICINOLEAT in Wistar rats was established to exceed 2000 mg/kg body weight.
Executive summary:

Assessment of acute dermal toxicity with ZINN(II)-RICINOLEAT in the rat.

The study was carried out based on the guidelines described in: EC Commission Directive 92/69/EEC, Part B.3, "Acute Toxicity-Dermal" and OECD No402, "Acute Dermal Toxicity". ZINN(II)-RICINOLEAT was administered to five Wistar rats of each sex by dermal application at 2000 mg/kg body weight for 24 hours. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (day 15). No mortality occurred. Hunched posture was noted among the females between days 3 and 8. Chromodacryorrhoea was noted among the animals on days 1 and 2. Erythema, scales, fissures and/or scabs were seen in the treated skin-area among the animals during the observation period. The body weight gain during the observation period was within the range expected for rats used in this type of study. Macroscopic post mortem examination of the surviving animals at termination did not reveal any abnormalities that were not commonly noted among rats of this age and strain or that were considered toxicologically significant.

The dermal LD50 value of ZINN(II)-RICINOLEAT in Wistar rats was established to exceed 2000 mg/kg body weight.