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EC number: 800-310-3 | CAS number: 78683-74-6
- 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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 2011-05-23 to 2011-10-10
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Justification for read-across: The tested substance is strucrally related to the target chemical, exhibiting same chemical fuctional groups. It is assumed that the tested substance and the target substance share the same toxic mode of action. Justification for reliability: Guideline study according to GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guidelineopen allclose all
- 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)
Test material
- Reference substance name:
- Dihydro-3-(tripropenyl)furan-2,5-dione
- EC Number:
- 295-556-6
- EC Name:
- Dihydro-3-(tripropenyl)furan-2,5-dione
- Cas Number:
- 92077-08-2
- IUPAC Name:
- 92077-08-2
- Reference substance name:
- Tripropenyl succinic anhydride
- IUPAC Name:
- Tripropenyl succinic anhydride
- Details on test material:
- Name: Tripropenyl succinic anhydride
CAS No.: 92077-08-2
Batch No.: ESD0010823
Certificate of Analysis: number or date will be reported in the final report
Chemical Name: dihydro-3-(tripropenyl)furan-2,5-dione
Molecular Weight: ca 220 (calculated value, the exact value will be
defined in the final report)
pH: 1-2
Physical State at RT: liquid
Density: 1.01 g/cm3 (20°C, DIN 51757)
Colour: yellow to brown
Expiry Date: 01.12.2012
Storage Conditions: at room temperature
Safety Precautions: The routine hygienic procedures were sufficient to assure personnel health and safety.
Constituent 1
Constituent 2
In vivo test system
Test animals
- 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
Study design: in vivo (LLNA)
- 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.
Results and discussion
- 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
In vivo (LLNA)
Resultsopen allclose all
- 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
Any other information on results incl. tables
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 |
The analogue approach using tripropenyl succinic anhydride as source chemical is justified (target chemical: pentapropenyl succinic anhydride; source chemical: tripropenyl succinic anhydride):
The target chemical belongs to the homologues series of higher alkenyl succinic anhydride (ASA), where there is different number of propyl units. Therefore, it can be assumed that target chemical and other ASA member (tripropenyl succinic anhydride) share the same toxic mode of action.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- The target chemical is considered to be a skin sensitizer.
- Executive summary:
The sensitisation potential of pentapropenyl succinic anhydride was assessed base on the read-across approach using tripropenyl succinic anhydride as read-across supporting substance. The skin sensitization potential of tripropenyl succinic anhydride was investigated according to test guidline 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%. Likewise, the target chemical pentapropenyl succinic anhydride is considered to be a skin sensitizer.
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