Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 270-109-8 | CAS number: 68411-20-1
- 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
Endpoint summary
Administrative data
Description of key information
A modified Local Lymph Node Assay (IMDS) was performed on 24 female NMRI mice of the strain HsdWinin:NMRI (6 animals/test item group and 6 control animals) to determine if there is any specific (sensitizing) or non-specific (irritant) stimulating potential of the test item Butanal, reaction products with aniline.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Principles of method if other than guideline:
- The modified Local Lymph Node Assay (IMDS) was performed on 24 female NMRI mice of the strain HsdWinin:NMRI(6 animals/test item group and 6 control animals) to determine if there is any specific (sensitizing) or non-specific (irritant) stimulating potential of the test item Butanal, reaction products with aniline.
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- Group 1 Vehicle (A/OO - acetone/olive oil (4:1))
Group 2 3% Butanal, reaction products with aniline (in A/OO)
Group 3 10% Butanal, reaction products with aniline (in A/OO)
Group 4 30% Butanal, reaction products with aniline (in A/OO)
Group 5 30% Alpha Hexyl Cinnamic Aldehyde (in A/OO) - No. of animals per dose:
- 6 animals/test item group and 6 control animals
- Parameter:
- SI
- Remarks:
- Cell count index
- Value:
- 1
- Test group / Remarks:
- Group 1: Vehicle (A/00)
- Remarks on result:
- other:
- Remarks:
- A modified Local Lymph Node Assay (IMDS) was carried out in mice. The modifications refer to the measurement of cell proliferation by cell counting instead of radioactive labeling. In addition, the acute inflammatory skin reaction is determined to discriminate specific from non-specific activation of immune competent cells in the draining lymph nodes, as also recommend in the update of OECD TG 429.
- Parameter:
- SI
- Remarks:
- Cell count index
- Value:
- 1.02
- Test group / Remarks:
- Group 2: 3 % Butanal, reaction products with aniline (in A/00)
- Remarks on result:
- other:
- Remarks:
- A modified Local Lymph Node Assay (IMDS) was carried out in mice. The modifications refer to the measurement of cell proliferation by cell counting instead of radioactive labeling. In addition, the acute inflammatory skin reaction is determined to discriminate specific from non-specific activation of immune competent cells in the draining lymph nodes, as also recommend in the update of OECD TG 429.
- Parameter:
- SI
- Remarks:
- Cell count index
- Value:
- 1.25
- Test group / Remarks:
- Group 3: 10 % Butanal, reaction products with aniline (in A/00)
- Remarks on result:
- other:
- Remarks:
- A modified Local Lymph Node Assay (IMDS) was carried out in mice. The modifications refer to the measurement of cell proliferation by cell counting instead of radioactive labeling. In addition, the acute inflammatory skin reaction is determined to discriminate specific from non-specific activation of immune competent cells in the draining lymph nodes, as also recommend in the update of OECD TG 429.
- Parameter:
- SI
- Remarks:
- Cell count index
- Value:
- 1.41
- Test group / Remarks:
- Group 4: 30% Butanal, reaction products with aniline (in A/00)
- Remarks on result:
- other:
- Remarks:
- A modified Local Lymph Node Assay (IMDS) was carried out in mice. The modifications refer to the measurement of cell proliferation by cell counting instead of radioactive labeling. In addition, the acute inflammatory skin reaction is determined to discriminate specific from non-specific activation of immune competent cells in the draining lymph nodes, as also recommend in the update of OECD TG 429.
- Parameter:
- SI
- Remarks:
- Cell count index
- Value:
- 1.45
- Test group / Remarks:
- Group 5: 30 %Alpha Hexyl Cinnamic Aldehyde (in A/00) - positive control
- Remarks on result:
- other:
- Remarks:
- A modified Local Lymph Node Assay (IMDS) was carried out in mice. The modifications refer to the measurement of cell proliferation by cell counting instead of radioactive labeling. In addition, the acute inflammatory skin reaction is determined to discriminate specific from non-specific activation of immune competent cells in the draining lymph nodes, as also recommend in the update of OECD TG 429.
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Executive summary:
A modified Local Lymph Node Assay (IMDS) was performed on 24 female NMRI mice of the strain HsdWin:NMRI (6 animals/test item group and 6 control animals) to determine if there is any specific (sensitizing) or non-specific (irritant) stimulating potential of the test item Butanal, reaction products with aniline.
A concurrent control of 6 animals treated with Alpha Hexyl Cinnamic Aldehyde was included.
The study was conducted according to OECD Guidelines No. 429 and No. 406,
EC Guideline 2004/73/EC (29th Adaptation of Guideline 67/548/EEC, B.42)/Health Effects Test Guideline and OPPTS 870.2600 (EPA) with the following test item concentrations:
Test item: 0 % (vehicle control), 3 %, 10 % and 30 %.
Positive control: 30 % Alpha Hexyl Cinnamic Aldehyde
The test item and the positive control were formulated in acetone/olive oil (4:1) (A/OO) to yield a solution.
Compared to vehicle treated animals there was an increase regarding the cell counts in the high dose group, which is of no statistical significance. The "positive level" of index 1.4 for the cell counts has been exceeded in this dose group.
The “positive level” of ear swelling, which is 2x10E-2 mm increase, i.e. about 10 % of the control values, has not been reached or exceeded in any dose group.
Nevertheless a statistically significant increase of the ear weight has been detected after administration of the mid concentration of the test item. Although this effect is not corroborated by increase in ear swelling an irritant potential cannot be excluded.
In conclusion, these results show that the test item Butanal, reaction products with aniline may have a weak sensitizing potential in mice after dermal application of a 30 % concentration with an EC value of 28.75 %.
Therefore, the concentration of 10 % turned out to be the NOEL for the parameters investigated in this study with respect to skin sensitization.
These results are verified by the comparison with the results of the positive control group (Alpha Hexyl Cinnamic Aldehyde).
Reference
Compared to vehicle treated animals there was an increase regarding the cell counts in the high dose group, which is of no statistical significance. The "positive level" of index 1.4 for the cell counts has been exceeded in this dose group.
The “positive level” of ear swelling, which is 2x10E-2 mm increase, i.e. about 10 % of the control values, has not been reached or exceeded in any dose group.
Nevertheless a statistically significant increase of the ear weight has been detected after administration of the mid concentration of the test item. Although this effect is not corroborated by increase in ear swelling an irritant potential cannot be excluded.
Direct LLNA (NMRI mice, female, 6 animals/group)
Groups | Weight index (index of mean+/- SD in%) | Cell count index (index of mean+/- SD in%) |
Gr. 1 | 1.00 +/- 35.01 | 1.00 +/- 52.31 |
Gr. 2 | 0.99 +/- 24.05 | 1.02 +/- 31.64 |
Gr. 3 | 1.13 +/- 32.94 | 1.25 +/- 24.05 |
Gr. 4 | 1.15 +/- 10.62 | 1.41 +/- 22.41 |
Gr. 5 | 1.37 +/- 17.96 | 1.45 +/- 9.41 |
Ear swelling (NMRI mice, female, 6 animals/group, in 0.01 mm)
Groups | day 1 (mean+/- SD in%) | day 4 (mean+/- SD in%) | Index day 4 |
Gr. 1 | 17.33 +/- 2.84 | 18.17 +/- 7.73 | 1.00 |
Gr. 2 | 17.17 +/- 2.27 | 18.58 +/- 6.67 | 1.02 |
Gr. 3 | 17.42 +/- 4.55 | 19.50 +/- 5.99 | 1.07 |
Gr. 4 | 17.33 +/- 2.84 | 19.67 +/- 10.25 | 1.08 |
Gr. 5 | 17.67 +/- 4.41 | 19.92 +/- 3.36 * | 1.09 |
* = statistically significant increase (p <= 0.05)
Ear weight (NMRI mice, female, 6 animals/group, in mg per 8 mm diameter punch)
Groups |
day 4 (mean+/- SD in%) |
Index day 4 |
Gr. 1 |
12.88 +/- 9.04 |
1.00 |
Gr. 2 |
13.64 +/- 10.68 |
1.06 |
Gr. 3 |
14.95* +/- 6.05 |
1.16 |
Gr. 4 |
13.82 +/- 12.78 |
1.07 |
Gr. 5 |
13.90 +/- 8.12 |
1.08 |
* = statistically significant increase (p <= 0.05)
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
The results of the modified LLNA showed that the test item Butanal, reaction products with aniline may have a weak sensitizing potential in mice after dermal application of a 30 % concentration with an EC value of 28.75 %.
Justification for selection of skin sensitisation endpoint:
Key study is used
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
In the LLNA an EC value of 28.75 % was determined. According to CLP classification criteria (Regulation (EC) No 1272/2008) as Skin Sens.1 B is justified.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.