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EC number: 295-556-6 | CAS number: 92077-08-2
- 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
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- 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
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- Endpoint summary
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- 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
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
- Study period:
- 2011-05-23 to 2011-10-10
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- (Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, München, Germany)
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental 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 (preliminary test: lot no. 1125, 1130 and 1307 , main study: lot no. 1125)
- Free access to tap water, sulphur acidified to a pH value of approx. 2.8 (drinking water, municipal residue control, microbiological controls at re gular intervals)
- The animals were kept in groups of 5 animals in IVC cages, type II L, polysulphone cages on Altromin saw fibre bedding (preliminary test: lot no. 241110 and 141110, main study: lot no. 241110)
- Certificates of food, water and bedding are filed at BSL BIOSERVICE
- Adequate acclimatisation period (at least five days) under laboratory conditions - Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- Based on the results observed in the preliminary test the following test item concentrations were selected for the main study:
6.25 %, 12.5 % and 25 % (v/v)
The preparations were made immediately prior to each dosing.
AOO was used as vehicle and served as negative control. - No. of animals per dose:
- 5 animals/dose group, 5 animals/control group
9 animals for the preliminary test - Details on study design:
- Preliminary Test
In order to determine the highest tolerated and non-irritant test concentration a preliminary test was performed.
For this purpose, six animals were treated by topical application with the test item on three consecutive days at the
following concentrations to the entire dorsal surface of each ear:
Animal no. 1 and no. 2 were treated with a test item concentration of 100% (undiluted).
Animal no. 4 and no. 5 were treated with a test item concentration of 50%, diluted with AOO
(Acetone, Prolabo, lot no. K41154114, expiry date: 06/2015; olive oil highly refined, Sigma, lot no. BCBD1085, expiry date: 06/2011).
Animal no. 7 and no. 8 were treated with a test item concentration of 25%, diluted with AOO.
Three further animals were treated with 100% AOO and served as negative control.
Immediately before the first application, approximately 48 hours after the first application and shortly before
sacrificing the thickness of both ears of the surviving animals was measured.
Cageside observations included spontaneous activity, lethargy, recumbent position, convulsions,
tremors, apnoea, asphyxia, vocalisation, diarrhoea, changes in the skin and fur, eyes and mucous membranes (salivation, discharge).
Animals no. 1 and no. 2 showed sticky fur at the application sites on day two of the preliminary test.
Neither signs of systemic toxicity nor signs of irritation at the application site could be detected in any animal.
On day 3 of the preliminary test, animal no. 1 was found dead and animal no. 2 was moribund and therefore
had to be euthanised due to animal welfare reasons.
Animals no. 4 and no. 5 showed hair loss, severe eschar and desquamation on day 6.
Animals no. 7 and no. 8 showed desquamation on day 6
One animal from the 25% group showed a weight loss of 3 g. All other animals showed the expected weight development,
which includes a weight loss of up to 2 g throughout the duration of the preliminary test.
Preparation of the Animals
The animals were randomly selected.
Identification was ensured by cage number and individual marking (tail).
Clinical Observation
Prior to the application and once a day thereafter all animals were observed in order to detect signs of toxicity,
including dermal irritation at site of application.
Weight Assessment
The animals were weighed prior to the application and at the end of the test period (prior to the treatment with 3HTdR).
Dose Groups
3 test groups (3 different concentrations) and 1 negative control group (vehicle) were tested.
Test Regime
Topical Application
Each mouse was treated by topical application of 25 µL of the selected solution to the entire dorsal surface of each ear.
Topical applications were performed once daily over three consecutive days.
Administration of 3H-Methyl Thymidine
Five days after the first topical application all mice were dosed with 20 µCi 3H-methyl thymidine by intravenous injection (tail vein) of 250µL of 3H-methyl thymidine, diluted to a working concentration of 80µCi/mL.
Preparation of Cell Suspension
Approximately 5 hours after the injection of 3H-methyl thymidine all mice were sacrificed by cervical dislocation.
The draining “auricular lymph nodes” were excised, weighed, individually pooled for each animal (2 lymph nodes per animal)
and collected in phosphate buffered saline (PBS). A single cell suspension of pooled lymph node cells was prepared by gentle
mechanical disaggregation through polyamide gauze (200 mesh size). After washing the gauze with PBS the cell suspension was
pelleted in a centrifuge. The supernatant was discarded and the pellets were resuspended with PBS. This washing procedure was repeated.
After the final wash each pellet was resuspended in approx. 1 mL 5% TCA at approx. 4° C for approximately 18 hours for precipitation
of macromolecules. Each precipitate was once washed again, resuspended in 1 mL 5% TCA and 7 mL scintillation fluid was added.
Then this solution was transferred into scintillation vials and stored at room temperature overnight.
Determination of Incorporated 3H -Methyl Thymidine
The 3H-methyl thymidine – incorporation was measured in a ß-counter and expressed as the number of disintegrations per minute (DPM).
Similarly, background 3H-methyl thymidine levels were also measured (5% TCA). Determination of radioactivity was
performed individually for each animal.
Evaluation of Results
The proliferative response of lymph node cells was expressed as the number of radioactive disintegrations per minute per lymph
node (DPM/NODE) and as the ratio of 3H-methyl thymidine - incorporation into lymph node cells of test group animals relative to
that recorded for control group animals (STIMULATION INDEX). Before DPM/NODE values were determined, background values
were subtracted. EC3 values, calculated concentrations which induce stimulation indices of three, are determined by linear interpolation,
EC3=c+[(3-d)/(b-d)]x(a c), between two points of the stimulation indices axis, one above (a,b) and one below (c,d) the stimulation index of three.
If all measured points are above or below the stimulation index of three, no EC3 value can be stated.
In certain situations where the dose response does not incorporate a data point lying below the SI value of three, provided the data are of
good quality (relatively close to an SI of three and evidence of a dose response), an EC3 value may be estimated by using the two doses
closest to the SI value of three. The EC3 value is estimated by log-linear interpolation between these two points on a plane where
the x-axis represents the dose level and the y-axis represents the SI. The point with the higher SI is denoted (a,b) and the point with
the lower SI is denoted (c,d). The formula for the EC3 estimate is as follows: EC3=2^{(log2(c)+(3-d)/(b-d)*[(log2(a)-log2(c)]},
by log-transforming the doses, EC3 estimates will never fall below zero.
A substance is regarded as a 'sensitiser' in the LLNA if at least one concentration of the test item results in a 3-fold or greater
increase in 3H-methyl thymidine - incorporation into lymph node cells of the test group animals, relative to that recorded for
the lymph nodes of control group animals (Stimulation Index equal to or greater than 3.0).
On the basis of the test results, the following risk phrases may be assigned in conformity with the criteria given in Commission
Regulation (EU) No 286/2011 as well as in OECD-GHS - Globally Harmonised System of Classification and Labelling of Chemicals,
third revised edition, July 2009:
Skin sensitiser
Category 1:
A substance is classified as a skin sensitiser
a) if there is evidence in humans that the substance can lead to sensitisation by skin contact in a substantial number of persons, or
b) if there are positive results from an appropriate animal test.
WARNING, exclamation mark. May cause an allergic skin reaction.
Sub-category 1A:
Substances showing a high frequency of occurrence in humans and/or a high potency in animals can be presumed to have
the potential to produce significant sensitisation in humans. Severity of reaction may also be considered.
EC3 value ≤ 2%
WARNING, exclamation mark. May cause an allergic skin reaction.
Sub-category 1B:
Substances showing a low to moderate frequency of occurrence in humans and/or a low to moderate potency in animals
can be presumed to have the potential to produce sensitisation in humans. Severity of reaction may also be considered.
EC3 value > 2%
WARNING, exclamation mark. May cause an allergic skin reaction. - Positive control substance(s):
- other: Phenylenediamine
- Statistics:
- Outlier tests according to Dixon, Grubbs and Nalimov were performed for the values measured for the number of disintegrations per minute (DPM).
If outliers were identified, these values were not included in the calculation of the stimulation indices. As at least four values per group are
required for the evaluation of the results, the outlier test was not repeated to detect further outliers. - Positive control results:
- The recent reliability check was performed in July 2011.
The raw data of this study are kept in the BSL archives (BSL Project ID 110336 T).
Positive-control substance: P-Phenylenediamine (CAS 106-50-3, Sigma, purity > 98%; Lot 069K0076) 1%
Vehicle: AOO (4:1 (v/v) acetone/olive oil)
Species/strain: healthy CBA/CaOlaHsd mice
Source: Harlan Winkelmann GmbH, 33178 Borchen, Germany
Concentrations: 1% on three consecutive days
The Stimulation Index was 14.3 - Parameter:
- SI
- Remarks on result:
- other: see Remark
- Remarks:
- Each of the three tested concentrations exceeded the stimulation index of 3. The stimulation index at a concentration of 6.25% was 32.6 The stimulation index at a concentration of 12.5% was 43.5 The stimulation index at a concentration of 25% was 40.1 All animals survived throughout the test period without showing any clinical signs.
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: see Remark
- Remarks:
- Test Item Conc. [%] Animal number DPM Negative 16 1068.0 Control 17 875.0 18 3101.0* 19 1230.0 20 1139.0 MV 1078.0 SD 130.5 Tripropenyl 6.25 1 29128.0 2 34742.0 3 24534.0 4 48423.0 5 36803.0 MV 34726.0 SD 8088.7 Tripropenyl 12.5 6 47698.0 7 46643.0 9 43765.0 10 54537.0 MV 46328.4 SD 5092.1 Tripropenyl 25 11 41976.0 12 36813.0 13 50026.0 14 39867.0 15 44499.0 MV 42636.2 SD 4474.2 * = outlier, failed Grubbs, Nalimov and Dixon; n.d. = not determined
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The registered substance was considered to be a skin sensitizer. The EC3 value (derived by linear interpolation) was calculated to be at a test item concentration of 0.03%.
The results of the radioactivity determination are supported by the second endpoint, the means of the lymph node weights per group,
which showed dose-related increased values compared to the negative control values. - Executive summary:
The skin sensitisation potential of the registered substance was investigated in a local lymph node assay.
Based on the results of the preliminary test the test item was assessed for sensitising properties at concentrations of 6.25 %, 12.5 % and 25 % (v/v) in AOO (4:1 (v/v) acetone/olive oil). At the daily clinical observation the animals did not show any visible clinical symptoms and no case of mortality was observed.
Summary Results:
The mean weight of the lymph nodes
for the 6.25% test group was 11.5 mg
for the 12.5% test group was 13.8 mg
for the 25% test group was 14.2 mg
for the negative-control group was 2.9 mg
Each of the three tested concentrations exceeded the stimulation index of 3.
The stimulation index at a concentration of 6.25% was 32.6
The stimulation index at a concentration of 12.5% was 43.5
The stimulation index at a concentration of 25% was 40.1
Conclusion
On the basis of the test results obtained in the study, the test item is considered to be a skin sensitiser. The EC3 value (derived by linear interpolation) was calculated to be at a test item concentration of 0.03%.
The results of the radioactivity determination are supported by the second endpoint, the means of the lymph node weights per group,
which showed dose-related increased values compared to the negative control values.
Reference
Table Ear Thickness – Preliminary Test (mm)
Measurement of Ear Thickness (mm) | |||||||
Group | Animal | Day 1 | Day 3 | Day 6 | |||
No. | left | right | left | right | left | right | |
Tripropenyl succinic anhydride 100% |
1 | 0.18 | 0.18 | † | * | * | * |
Tripropenyl succinic anhydride 100% |
2 | 0.18 | 0.19 | †† | * | * | * |
Negative Control 100% AOO |
3 | 0.18 | 0.19 | * | * | * | * |
Tripropenyl succinic anhydride 50% in AOO |
4 | 0.20 | 0.21 | 0.21 | 0.21 | 0.22 | 0.22 |
Tripropenyl succinic anhydride 50% in AOO |
5 | 0.22 | 0.21 | 0.22 | 0.21 | 0.23 | 0.22 |
Negative Control 100% AOO |
6 | 0.21 | 0.21 | 0.21 | 0.21 | 0.21 | 0.21 |
Tripropenyl succinic anhydride 25% in AOO |
7 | 0.18 | 0.17 | 0.19 | 0.18 | 0.20 | 0.20 |
Tripropenyl succinic anhydride 25% in AOO |
8 | 0.17 | 0.17 | 0.19 | 0.20 | 0.20 | 0.18 |
Negative Control 100% AOO |
9 | 0.20 | 0.19 | 0.19 | 0.19 | 0.19 | 0.19 |
†= animal was found dead;††= animal was euthanised due to animal welfare reasons; * = no data available | |||||||
Table Absolute Body Weights – Preliminary Test (g)
Concentration | Animal No. |
Start of Study |
End of Study |
Weight Gain |
Tripropenyl succinic anhydride 100% |
1 | 20 | † | * |
Tripropenyl succinic anhydride 100% |
2 | 19 | †† | * |
Negative Control 100% AOO |
3 | 21 | * | * |
Tripropenyl succinic anhydride 50% in AOO |
4 | 18 | 18 | 0 |
Tripropenyl succinic anhydride 50% in AOO |
5 | 19 | 19 | 0 |
Negative Control 100% AOO |
6 | 19 | 20 | 1 |
Tripropenyl succinic anhydride 25% in AOO |
7 | 24 | 21 | -3 |
Tripropenyl succinic anhydride 25% in AOO |
8 | 23 | 22 | -1 |
Negative Control 100% AOO |
9 | 20 | 20 | 0 |
†= animal was found dead;††= animal was euthanised due to animal welfare reasons;*= no data available |
Table Radioactive Determination of the Positive-Control Group of the Recent Study
POS | CPM | Test Item | Conc. [%] | Animal number | DPM | DPM- mean back- ground | DPM/ Node | Stimu-lation Index | ||
6 | 722.0 | Negative | 6 | 1492.0 | 1478.0 | 739.0 | ||||
7 | 660.0 | Control | 7 | 1368.0 | 1354.0 | 677.0 | ||||
8 | 906.0 | 8 | 1881.0 | 1867.0 | 933.5 | |||||
9 | 487.0 | 9 | 1007.0 | 993.0 | 496.5 | |||||
10 | 919.0 | 10 | 1904.0 | 1890.0 | 945.0 | |||||
MV | 738.8 | MV | 1530.4 | 1516.4 | 758.2 | 1.0 | ||||
SD | 161.4 | SD | 335.9 | 335.9 | 168.0 | |||||
13 | 13285.0 | Phenylene- | 1 | 11 | 27709.0 | 27695.0 | 13847.5 | 18.3 | ||
14 | 8590.0 | diamine | 12 | 17850.0 | 17836.0 | 8918.0 | 11.8 | |||
15 | 12542.0 | 13 | 26145.0 | 26131.0 | 13065.5 | 17.2 | ||||
16 | 10239.0 | 14 | 21597.0 | 21583.0 | 10791.5 | 14.2 | ||||
17 | 7404.0 | 15 | 15359.0 | 15345.0 | 7672.5 | 10.1 | ||||
MV | 10412.0 | MV | 21732.0 | 21718.0 | 10859.0 | 14.3 | ||||
SD | 2244.5 | SD | 4709.6 | 4709.6 | 2354.8 | 3.1 | ||||
66 | 7.0 | Background | 15.0 | |||||||
67 | 8.0 | Szinti and | 16.0 | |||||||
68 | 7.0 | TCA | 13.0 | |||||||
69 | 7.0 | 14.0 | ||||||||
70 | 6.0 | 12.0 | ||||||||
MV | 7.0 | MV | 14.0 | 0.0 | 0.0 | 0.0 | ||||
SD | 0.6 | SD | 1.4 |
Table Radioactive Determination of the Test Substance Groups
POS | CPM | Test Item | Conc. [%] | Animal number | DPM | DPM- mean back- ground | DPM/ Node | Stimu-lation Index | ||
6 | 511.0 | Negative | 16 | 1068.0 | 1053.6 | 526.8 | ||||
7 | 421.0 | Control | 17 | 875.0 | 860.6 | 430.3 | ||||
8 | 1477.0* | 18 | 3101.0* | n.d. | n.d. | |||||
9 | 588.0 | 19 | 1230.0 | 1215.6 | 607.8 | |||||
10 | 547.0 | 20 | 1139.0 | 1124.6 | 562.3 | |||||
MV | 516.8 | MV | 1078.0 | 1063.6 | 531.8 | 1.0 | ||||
SD | 61.6 | SD | 130.5 | 130.5 | 65.3 | |||||
49 | 13757.0 | Tripropenyl | 6.25 | 1 | 29128.0 | 29113.6 | 14556.8 | 27.4 | ||
50 | 16315.0 | succinic | 2 | 34742.0 | 34727.6 | 17363.8 | 32.7 | |||
51 | 11626.0 | anhydride | 3 | 24534.0 | 24519.6 | 12259.8 | 23.1 | |||
52 | 22916.0 | in AOO | 4 | 48423.0 | 48408.6 | 24204.3 | 45.5 | |||
53 | 17112.0 | 5 | 36803.0 | 36788.6 | 18394.3 | 34.6 | ||||
MV | 16345.2 | MV | 34726.0 | 34711.6 | 17355.8 | 32.6 | ||||
SD | 3814.0 | SD | 8088.7 | 8088.7 | 4044.4 | 7.6 | ||||
54 | 22276.0 | Tripropenyl | 12.5 | 6 | 47698.0 | 47683.6 | 23841.8 | 44.8 | ||
55 | 22057.0 | succinic | 7 | 46643.0 | 46628.6 | 23314.3 | 43.8 | |||
56 | 18459.0 | anhydride | 8 | 38999.0 | 38984.6 | 19492.3 | 36.7 | |||
57 | 20419.0 | in AOO | 9 | 43765.0 | 43750.6 | 21875.3 | 41.1 | |||
58 | 25646.0 | 10 | 54537.0 | 54522.6 | 27261.3 | 51.3 | ||||
MV | 21771.4 | MV | 46328.4 | 46314.0 | 23157.0 | 43.5 | ||||
SD | 2372.7 | SD | 5092.1 | 5092.1 | 2546.0 | 4.8 | ||||
61 | 19812.0 | Tripropenyl | 25 | 11 | 41976.0 | 41961.6 | 20980.8 | 39.5 | ||
62 | 17891.0 | succinic | 12 | 36813.0 | 36798.6 | 18399.3 | 34.6 | |||
63 | 23553.0 | anhydride | 13 | 50026.0 | 50011.6 | 25005.8 | 47.0 | |||
64 | 18665.0 | in AOO | 14 | 39867.0 | 39852.6 | 19926.3 | 37.5 | |||
65 | 20915.0 | 15 | 44499.0 | 44484.6 | 22242.3 | 41.8 | ||||
MV | 20167.2 | MV | 42636.2 | 42621.8 | 21310.9 | 40.1 | ||||
SD | 1979.2 | SD | 4474.2 | 4474.2 | 2237.1 | 4.2 | ||||
66 | 6.0 | Background | 13.0 | |||||||
67 | 8.0 | Szinti and | 17.0 | |||||||
68 | 8.0 | TCA | 16.0 | |||||||
69 | 6.0 | 12.0 | ||||||||
70 | 7.0 | 14.0 | ||||||||
MV | 7.0 | MV | 14.4 | 0.0 | 0.0 | 0.0 | ||||
SD | 0.9 | SD | 1.9 | |||||||
* = outlier, failed Grubbs, Nalimov and Dixon; n.d. = not determined |
Table Absolute Body Weights in g
Concentration | Animal No. |
Start of Study |
End of Study |
Weight Gain |
Tripropenyl succinic | 1 | 21 | 22 | 1 |
anhydride | 2 | 19 | 21 | 2 |
3 | 18 | 20 | 2 | |
4 | 19 | 20 | 1 | |
6.25% in AOO | 5 | 20 | 21 | 1 |
Tripropenyl succinic | 6 | 20 | 21 | 1 |
anhydride | 7 | 17 | 18 | 1 |
8 | 20 | 23 | 3 | |
9 | 17 | 19 | 2 | |
12.5% in AOO | 10 | 17 | 19 | 2 |
Tripropenyl succinic | 11 | 20 | 21 | 1 |
anhydride | 12 | 19 | 21 | 2 |
13 | 19 | 20 | 1 | |
14 | 19 | 21 | 2 | |
25% in AOO | 15 | 20 | 22 | 2 |
16 | 18 | 20 | 2 | |
Negative | 17 | 21 | 21 | 0 |
Control | 18 | 22 | 23 | 1 |
100% AOO | 19 | 20 | 23 | 3 |
20 | 18 | 20 | 2 |
Individual Weight of Each Lymph Node and Means of Animals and Groups
Group | Animal | Left lymph | Right lymph | Mean of | Mean of |
No. | node weight (mg) |
node weight (mg) |
lymph node weights per animal (mg) | test group (mg) |
|
1 | 10.8 | 11.7 | 11.3 | ||
Tripropenyl succinic | 2 | 10.5 | 9.0 | 9.8 | |
anhydride | 3 | 10.7 | 9.2 | 10.0 | 11.5 |
6.25% in AOO | 4 | 13.3 | 12.4 | 12.9 | |
5 | 12.7 | 14.2 | 13.5 | ||
6 | 14.2 | 17.5 | 15.9 | ||
Tripropenyl succinic | 7 | 12.5 | 13.0 | 12.8 | |
anhydride | 8 | 11.2 | 14.5 | 12.9 | 13.8 |
12.5% in AOO | 9 | 13.8 | 13.1 | 13.5 | |
10 | 14.5 | 13.6 | 14.1 | ||
11 | 13.3 | 14.0 | 13.7 | ||
Tripropenyl succinic | 12 | 12.4 | 15.7 | 14.1 | |
anhydride | 13 | 14.5 | 14.6 | 14.6 | 14.2 |
25% in AOO | 14 | 12.5 | 17.4 | 15.0 | |
15 | 13.0 | 14.1 | 13.6 | ||
16 | 2.4 | 3.1 | 2.8 | ||
Negative Control | 17 | 2.1 | 3.1 | 2.6 | |
18 | 4.3 | 2.9 | 3.6 | 2.9 | |
100% AOO | 19 | 2.4 | 3.0 | 2.7 | |
20 | 2.6 | 3.1 | 2.9 |
Table Clinical Observation
Time of Observation |
Systemic Effects |
Local Effects |
Group 1, animals no. 1 – 5 / test item at a concentration of 6.25% in AOO |
||
Day 1 |
nsf |
nsf |
Day 2 |
nsf |
nsf |
Day 3 |
nsf |
nsf* |
Day 4 |
nsf |
nsf* |
Day 5 |
nsf |
nsf* |
Day 6 |
nsf |
nsf* |
Group 2, animals no. 6 – 10 / test item at a concentration of 12.5 % in AOO |
||
Day 1 |
nsf |
nsf |
Day 2 |
nsf |
nsf |
Day 3 |
nsf |
nsf* |
Day 4 |
nsf |
nsf* |
Day 5 |
nsf |
nsf* |
Day 6 |
nsf |
nsf* |
Group 3, animals no. 11 – 15 / test item at a concentration of 25 % in AOO |
||
Day 1 |
nsf |
nsf |
Day 2 |
nsf |
nsf |
Day 3 |
nsf |
nsf* |
Day 4 |
nsf |
nsf* |
Day 5 |
nsf |
nsf* |
Day 6 |
nsf |
nsf* |
Group 4, animals no. 16 – 20 / negative control AOO |
||
Day 1 |
nsf |
nsf |
Day 2 |
nsf |
nsf |
Day 3 |
nsf |
nsf |
Day 4 |
nsf |
nsf |
Day 5 |
nsf |
nsf |
Day 6 |
nsf |
nsf |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
The sensitisation potential of tripropenyl succinic anhydride was assessed in an LLNA study according to test guideline OECD 429 and positive result (skin sensitizer) was obtained. The EC3 value (derived by linear interpolation) was calculated to be at a test item concentration of 0.03%. Therefore the registered substance is considered to be a skin sensitizer.
Migrated from Short description of key information:
Skin sensitisation
LLNA study: sensitising, EC3: 0.03%
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the available data, it is concluded that tripropenyl succinic anhydride is subject to classification and labeling according to
Directive 67/548/EECand Regulation 1272/2008/EC regarding sensitisation. The registered substance is classified as R43 and Cat. 1A (H317: may cause an allergic skin reaction).
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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