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EC number: 270-109-8 | CAS number: 68411-20-1
Skin sensitisation
Administrative data
- 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
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
Materials and methods
Test guideline
- 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)
Test material
- Reference substance name:
- Butanal, reaction products with aniline
- EC Number:
- 270-109-8
- EC Name:
- Butanal, reaction products with aniline
- Cas Number:
- 68411-20-1
- IUPAC Name:
- aniline; butanal
- Test material form:
- other: liquid
- Details on test material:
- Butanal, reaction products with aniline (test item)
Test item: Butanal, reaction products with aniline
CAS No.: 68411-20-1
Chemical Name: Butanal, reaction products with aniline
Content (nitrogen): 6.6 % (not used for calculation)
pH-Value (diluted in water 1:9): 6.8
Physical state: liquid
Appearance: yellow
Storage: room temperature
Material Balance:
Component of
Butanal, reaction products with aniline: Aniline (component 1): 0.4 %
Sum of main and minor componds
(GC-FID-area-%): 96.6%
Nonvolatile residue at reduced pressure: 0.50%
Water content by Fischer technique: 2.75%
Sum: 99.9%
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male
Study design: in vivo (LLNA)
- 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
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- 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.
Any other information on results incl. tables
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)
Applicant's summary and conclusion
- 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).
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