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EC number: 230-796-7 | CAS number: 7324-02-9
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2021
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP study using OECD testing guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
- Report date:
- 2021
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- This study followed the procedures indicated by internal BSL Munich SOPs and the following internationally accepted guidelines and recommendations:
OECD Guidelines for Testing of Chemicals, Section 4, No. 423, “Acute Oral Toxicity – Acute Toxic Class Method” adopted 17 December 2001
Commission Regulation (EC) No. 440/2008, L 142, Annex Part B, Method B.1, tris 30 May 2008
EPA Health Effects Test Guidelines, OPPTS 870.1100 “Acute oral toxicity”, EPA 712-C-02-190, December 2002
Procedures and facilities comply with the requirements of Directive 2010/63/EU and the national legislation defined in the animal protection law concerning the protection of animals used for experimental and other scientific procedures.
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- “Chemicals Act” of the Federal Republic of Germany, Appendix 1 to § 19a as amended and promulgated on October 30, 2020 (BGBl. I S. 2232) “Consensus Document of the National and Länder Working Party on Good Laboratory Practice“
- Test type:
- acute toxic class method
Test material
- Reference substance name:
- Allyl 2-cyanoacrylate
- EC Number:
- 230-796-7
- EC Name:
- Allyl 2-cyanoacrylate
- Cas Number:
- 7324-02-9
- Molecular formula:
- C7H7NO2
- IUPAC Name:
- prop-2-en-1-yl 2-cyanoprop-2-enoate
- Test material form:
- liquid
1
- Specific details on test material used for the study:
- Storage Condition of allyl 2-cyanoacrylate: 2–8 °C, protected from light, since test substance polymerizes very fast upon contact with water or even moisture; contact with water or aqueous materials must be avoided.
The extraction of the test item was performed according to guideline ISO 10993-12.
In total a ratio of 0.2 g of the polymerized test item per mL extraction medium was used.
Extraction conditions: 37 ±1 °C for 72 ± 2 h, under agitation.
Extraction media: physiological saline 0.9% NaCl, B. Braun Melsungen
Step 1: lot no. 20416406, expiry date: 09/2023
Step 2: lot no. 20192410, expiry date: 04/2023
cottonseed oil, Sigma-Aldrich
Step 1: lot no. MKCD7646, expiry date: 13/01/2022
Step 2: lot no. MKCD7646, expiry date: 14/01/2022
The extraction procedure did not reveal any abnormalities in any of the extraction media or the test item. No changes regarding clarity, colour and presence or absence of foreign material in any of the extracts were noted.
The extracts were neither pH-adapted nor filtered, centrifuged, diluted nor changed in any other way before application.
Up to the application within 15 minutes (step 1) or 10 minutes (step 2), the extracts were stored at room temperature.
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- Species/strain: healthy rats / WISTAR Crl: WI(Han)
Source: Charles River, 97633 Sulzfeld, Germany
Sex: female (non-pregnant, nulliparous)
Age at the beginning of the study: 8 – 11 weeks old
Body weight at the beginning of the study: Step 1: 165 – 184 g; Step 2: 175 – 199 g
Number of animals: 3 per step / extract, 2 steps per extract were performed (12 animals in total)
The animals were derived from a controlled full-barrier maintained breeding system (SPF). According to the German Act on Animal Welfare the animals were bred for experimental purposes.
This study was performed in an AAALAC-accredited laboratory. According to German animal protection law, the study type has been reviewed and accepted by local authorities. Furthermore, the study has been subjected to Ethical Review Process and was authorised by the Bavarian animal welfare administration.
The animals were randomly selected.
The animals were marked by tail-painting for individual identification.
Prior to the administration a detailed clinical observation of all animals was made. Only healthy animals were used for the test.
Prior to the administration food was withheld from the test animals for approximately 18 hours (access to water was permitted). Following the period of fasting the animals were weighed and the test item was administered. Food was provided again approximately 3 hours post dosing.
Body Weight: Animals were weighed on day 1 (prior to the administration) and on days 2, 3, 4, 8 and 15.
Housing and Feeding Conditions
- Full barrier in an air-conditioned room
- Temperature: 22 ± 3 °C
- Relative humidity: 55 ± 10%
- Artificial light, sequence being 12 hours light, 12 hours dark
- Air change: at least 10 x / hour
- Free access to Altromin 1324 maintenance diet for rats and mice
- Free access to tap water, sulphur acidified to a pH value of approx. 2.8 (drinking water, municipal residue control, microbiological controls at regular intervals)
- The animals were kept in groups in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding
- Certificates of food, water and bedding are filed for two years at BSL Munich and afterwards archived at Eurofins Munich
- Adequate acclimatisation period (at least 5 days) under laboratory conditions
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- Each test item extract was administered undiluted at a single dose by gavage using a feeding tube.
Volume of administration: Each test item extract (100% concentration) was administered according to the body weight at a volume of 10 mL/kg bw. - Doses:
- In total a ratio of 0.2 g of the polymerized test item per mL extraction medium was used as follows physiological saline 0.9% NaCl 10ml, cottonseed oil 10ml.
- No. of animals per sex per dose:
- 3 per step / extract, 2 steps per extract were performed (12 animals in total)
- Control animals:
- not specified
- Details on study design:
- The test for acute toxicity is performed on the rat. Although several mammalian species may be used, the rat has been the preferred rodent species.
It is the principle of the acute toxic class method that, based on a stepwise procedure with the use of a minimum number of animals per step, sufficient information is obtained on the acute toxicity of the test item. Absence or presence of compound-related mortality of the animals dosed at one step will determine the next step.
The animals were observed for 14 days after dosing. A careful clinical examination was made several times on the day of dosing (at least once during the first 30 minutes and with special attention given during the first 4 hours post-dose). Thereafter, the animals were observed for clinical signs once daily until the end of the observation period.
Cageside observations included changes in the skin and fur, eyes and mucous membranes. Also respiratory, circulatory, autonomic and central nervous systems and somatomotor activity and behaviour pattern were examined. Particular attention was directed to observations of tremor, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
No validated in vitro method is available for assessing acute systemic toxicity.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat. (total fraction)
- Remarks:
- Extracts of the test item were administered. The extraction of the test item was performed according to guideline ISO 10993-12. In total a ratio of 0.2 g of the polymerized test item per mL extraction medium was used.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- No mortality (0/6)
- Clinical signs:
- other: All animals survived throughout the test period without showing any clinical signs of toxicity. The piloerection observed on day 1 in all animals is not considered to be related to the test item but to the administration procedure and the possible stress
- Gross pathology:
- No specific gross pathological changes were recorded for any animal.
- Other findings:
- Clinical Signs
Any other information on results incl. tables
Clinical Signs Extraction Medium: Physiological Saline 0.9% NaCl
Time of Observation Post-Administration | Step 1 | Step 2 |
0 min – 180 min | nsf | nsf |
180 min – 240 min | slight piloerection | slight piloerection |
240 min – d 15 | nsf | nsf |
Clinical Signs Extraction Medium: Cottonseed Oil
Time of Observation Post-Administration | Step 1 | Step 2 |
0 min – 180 min | nsf | nsf |
180 min – 240 min | slight piloerection | slight piloerection |
240 min – d 15 | nsf | nsf |
d = study day (study day 1 = day of administration); min = minute(s) post-application; nsf = no specific findings
Step 1, Extraction Medium: Physiological Saline 0.9% NaCl
Day | Animal Number 1 | Animal Number 2 | Animal Number 3 |
1 | 165 | 167 | 165 |
2 | 176 | 180 | 180 |
3 | 161 | 169 | 175 |
4 | 174 | 188 | 188 |
8 | 184 | 198 | 199 |
15 | 204 | 207 | 205 |
Weight Gain (Day 1-15) g | 39 | 40 | 40 |
Body Weight Change in Comparison to Day 1 (%) | 23.6 | 24 | 24.2 |
Step 1, Extraction Medium:Cottonseed Oil
Day | Animal Number 4 | Animal Number 5 | Animal Number 6 |
1 | 184 | 171 | 182 |
2 | 196 | 183 | 196 |
3 | 191 | 185 | 188 |
4 | 190 | 184 | 195 |
8 | 200 | 192 | 210 |
15 | 214 | 198 | 210 |
Weight Gain (Day 1-15) (g) | 30 | 27 | 28 |
Body Weight Change in Comparison to Day 1 (%) | 16.3 | 15.8 | 15.4 |
Step 2, Extraction Medium: Physiological Saline 0.9% NaCl
Day | Animal Number 7 | Animal Number 8 | Animal Number 9 |
1 | 199 | 184 | 175 |
2 | 210 | 194 | 192 |
3 | 212 | 195 | 195 |
4 | 213 | 192 | 193 |
8 | 220 | 201 | 196 |
15 | 225 | 210 | 206 |
Weight Gain (Day 1-15) (g) | 26 | 26 | 31 |
Body Weight Change in Comparison to Day 1 (%) | 13.1 | 14.1 | 17.1 |
Step 2, Extraction Medium:Cottonseed Oil
Day | Animal Number 10 | Animal Number 11 | Animal Number 12 |
1 | 190 | 179 | 177 |
2 | 202 | 192 | 189 |
3 | 208 | 196 | 194 |
4 | 210 | 197 | 195 |
8 | 216 | 203 | 195 |
15 | 218 | 210 | 205 |
Weight Gain (Day 1-15) (g) | 28 | 31 | 28 |
Body Weight Change in Comparison to Day 1 (%) | 14.7 | 17.3 | 15.8 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the present study it can be stated that the test item Allyl 2-cyanoacrylate showed no acute toxic characteristics.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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