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EC number: 700-814-2 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2000-07-05 to 2000-07-12
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- ZINN(II)-RICINOLEAT
- IUPAC Name:
- ZINN(II)-RICINOLEAT
- 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
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Species : Albino Rabbit, New Zealand White, (SPF-Quality). Recognised by international guidelines as the recommended test system (e.g. EC, OECD)
Source : Charles River Deutschland, Kisslegg, Germany.
Number of animals : 3 Animals of one sex.
Age and body weight : Animals used within the study were at least 6 weeks old and body weights were less than 3.5 kg.
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 cages with perforated floors (Scanbur, Denmark) and equipped with an automatic drinking system (ITL, Bergen, The Netherlands). Acclimatisation period was at least 5 days before start of treatment under laboratory conditions.
Diet : Standard laboratory rabbit diet (Charles River Breeding and Maintenance Diet for Rabbits, Altromin, Germany) approx. 100 g. per day. Certificates of analysis were examined and retained in the NOTOX archives. In addition, hay (BMI, Helmond, the Netherlands) was provided once a week.
Water : Free access to tap-water. Certificates of quarterly analysis were examined and retained in the NOTOX archives.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: adjacent area of untreated skin
- Amount / concentration applied:
- Each animal was treated by dermal application of 0.5 ml of the test substance.
- Duration of treatment / exposure:
- The test substance was applied to the skin of one flank, using a metalline patch# of 2x3 cm. The patch was mounted on Micropore tape*, which was wrapped around the abdomen and secured with Coban elastic bandage*. Four hours after the application, the dressing was removed and the skin cleaned of residual test substance using water and ethanol.
* Supplier: Lohmann GmbH, Neuwied, Germany.
* Supplier: 3M, St. Paul, Minnesota, U.S.A. - Observation period:
- The skin reactions were assessed at approximately 1 , 24, 48 and 72 hours and 7 days after the removal of the dressings and test substance.
- Number of animals:
- 3
- Details on study design:
- Approximately 24 hours before treatment, the dorsal fur was clipped with electric clippers, exposing an area of approximately 150 square centimeters (1 Ox15 cm). Whenever considered necessary the treated skin areas were re-clipped at least 3 hours before the observations, to facilitate scoring.
A health inspection was performed prior to the 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 abnormalities.
Observations:
Mortality/viability : Twice daily.
Toxicity : At least once daily.
Body Weight : Day of treatment (prior to application).
Irritation : The skin reactions were assessed at approximately 1 , 24, 48 and 72 hours and 7 days after the removal of the dressings and test substance. The irritation scores and a description of all other (local) effects were recorded. Adjacent areas of the untreated skin of each animal served as controls.
No histopathology was performed, since the skin reactions were not masked by test substance staining.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: #1, #2, #3
- Time point:
- other: mean 24, 48, 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Scaliness was noted in all animals at termination (after 7 days), which was considered to be a reversible skin reaction.
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: mean 24, 48, 72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: mean 24, 48, 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: mean 24, 48, 72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- Exposure resulted in well-defined erythema and slight oedema in the treated skin-areas, which had been resolved within 7 days after exposure in all animals. Scaliness was noted in all animals at termination
(after 7 days). The scaliness, seen at termination, was considered to be a reversible skin reaction. - Other effects:
- No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Any other information on results incl. tables
Individual irritation scores:
Animal number: |
1 hour |
24 hours |
48 hours |
72 hours |
7 days |
Average 24 – 72 hours |
Erythema: |
||||||
1 |
2 |
2 |
2 |
2 |
0 |
2 |
2 |
2 |
2 |
2 |
2 |
0 |
2 |
3 |
2 |
2 |
2 |
2 |
0 |
2 |
Edema: |
||||||
1 |
2 |
1 |
0 |
0 |
0 |
0.33 |
2 |
2 |
1 |
1 |
1 |
0 |
1 |
3 |
2 |
1 |
1 |
0 |
0 |
0.67 |
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:
- Interpretation is based on erythema/eschar and edema calculated as mean scores for each animal following grading at 24, 48 and 72 hours after removal of the test material, in consideration of reversibility.The scaliness, seen at termination, was considered to be a reversible skin reaction.
According to CLP, EU GHS (Regulation (EC) No 1272/2008) no classification is required for ZINN(II)-RICINOLEAT - Executive summary:
Primary skin irritation/corrosion study with ZINN(II)-RICINOLEAT in the rabbit (4-hour semiocclusive application).
The study was carried out based on the guidelines described in: EC Commission Directive 92/69/EEC, 8.4, "Acute Toxicity - Skin irritation" and OECD No 404, "Acute Dermal Irritation/Corrosion" . Three rabbits were exposed to 0.5 ml of ZINN(II)-RICINOLEAT, applied onto clipped skin for 4 hours using a semi-occlusive dressing. Observations were made 1, 24, 48 and 72 hours and 7 days after exposure. Exposure to ZINN(II)-RICINOLEAT resulted in well-defined erythema and slight oedema in the treated skin-areas of the three rabbits. The skin irritation had resolved within 7 days after exposure in all animals. Scaliness was noted in all animals at termination (after 7 days). Remnants of the test substance were present on the skin of all animals on day 1. The scaliness, seen at termination, was considered to be a reversible skin reaction.
Interpretation of study results is based on mean scores for each animal following grading at 24, 48 and 72 hours for erythema and oedema:
· according to CLP, EU GHS (Regulation (EC) No 1272/2008): not irritating
(mean score erythema or edema 24, 48 , 72 hours of min. 2 of 3 is ≥ 2.3 - ≤ 4.0)
· according to Directive 67/548/EEC: irritating R38
(mean score erythema or edema 24, 48, 72 hours of min. 2 of 3 is ≥ 2)
The reported scaliness at study termination after 7 days was considered to be a reversible skin reaction.
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