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EC number: 407-870-4 | CAS number: 97384-48-0 CITROWANIL B
- 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 (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- June 25th -July 22nd, 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Test according to the method of B. Magnusson and A.M. Kligman (OECD-guideline 406 [1981] and EEC-guidelines 84/449/EEC [1984]) The test was performed according to the "OECD Principles of Good Laboratory Practice" in Testing of Chemicals, OECD, (Paris 1982).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- Positive Control: DNCB; 20 Control animals; Scoring system according to DRAIZE)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- Positive Control: DNCB; 20 Control animals
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- CITROWANIL B, Batch 890316, colourless, clear, viscous liquid
- IUPAC Name:
- CITROWANIL B, Batch 890316, colourless, clear, viscous liquid
- Reference substance name:
- 2-benzyl-2-methyl-3-butennitril
- IUPAC Name:
- 2-benzyl-2-methyl-3-butennitril
- Details on test material:
- Citrowanil B
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- Test animals: white Guinea-pigs, strain: Pribright, substrain: Bor: DHPW (SPF); source: Firma Winkelmann, Versuchstierzucht, Gartenstraße 30, D-4791 Borchen 1; Weight at the beginning of the study: 265 - 374 g; The used strain is sensitive to known allergenic compounds, which is based on repeated studies with positive control substanzes (e.g. DNCB).
Husbandry: Caging: max. 5 animals in one cage; Cagetype: Macrolon plastic cages IV (20 cm high, 33 cm width, 55 cm length); Lighting: Fluorescent light, 120 lux; Lighting period: 12 hours daily, from 7.00 a.m. to 7.00 p.m.; Temperature: 18 +/- 2 °C; Relative humidity: 50 - 85 %.
Food and feeding: Ssniff-G (Alleindiät für Meerschweinchen) ad libitum; Producer: Ssniff Spezialitäten GmbH.
Bedding: LIGNOCEL 3/4 Fasern (sterilisation at 180 °C, water binding capacity: 276.5 % of bedding); Producer: J. Rettenmaier & Söhne GmbH + Co., D-7092 Ellwangen-Holzmühle; Production: from pure soft wood, dried, disdusted and sterilized.
Water: ad libitum; System: Macrolon drinking bottles, 300 ml, Fa.Becker & Co., D-4629 Castrup-Rauxel; Quality: Aqua fontana as for human consumtion.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- arachis oil
- Concentration / amount:
- Intradermal induction: 10 % in vehicle and 10 % in FCA dilution
Epicutane induction: 10 % in vehicle
Epicutane challenge: 1 % in vehicle
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- arachis oil
- Concentration / amount:
- Intradermal induction: 10 % in vehicle and 10 % in FCA dilution
Epicutane induction: 10 % in vehicle
Epicutane challenge: 1 % in vehicle
- No. of animals per dose:
- 20
- Details on study design:
- Range Finding:
Two animals per group were treated dermally in a preliminary study under occlusiv conditions with the following concentrations (each 0.5 or 0.1 ml per animal) of the test sample:
dermal: 100 % (undiluted), 10 %, 5 %, 2.5 % and 1 % in aleum arachidis
intradermal: 10 %, 5 %, 2.5 % and 1 % in aleum arachidis
Main Study:
After an acclimatisation time of 7 days at least, the test was initiated. The guinea-pigs were divided into 2 groups (1 test- and 1 control-group) of 20 animals each (10 male and 10 female). Prior to treatement the shoulder of each animal was clipped with a small animal clipper (about 8x5 cm).
On the day of the experiment all animals of both groups were treated intradermally into two skin areas situated bilateral to the spine. The first injection sites were located at the craniodorsal area. The following injections were performed thereunder.
1. injection: 0.1 ml of FCA dilution
2. injection: 0.1 ml of Test sample in vehicle or for the control undiluted vehicle alone.
3. injection: 0.1 ml of Test sample in FCA dilution of for the control 10 % vehicle in FCA dilution
The adjuvant injections were made deep into the dermis to minimize sloughing.
7 days later the same sites were treated dermally with 0.5 ml of the test sample or vehicle. After the application the treated areas were covered with a gauze pad and fixed to the animals trunks with Elanoplast (Closed Patch Test). 48 h p.a. the bandage was removed.
3 weeks after the first intradermal treatment a second dermal treatment was carried out on both test- and control group as described above using "Hill-Top" Chambers. 0.5 ml of 1 % test sample in vehicle were applied to the left clipped flank of all animals and 0.5 ml of undiluted vehicle were applied to the right clipped flank of all animals. 24 h p.a. the bandages were removed.
One day thereafter the first evaluation was conducted (= 24 h value). 48 h after patch removing the 2nd evaluation (= 48 h value) was done. - Challenge controls:
- 1 % of the test sample in vehicle was the highest concentration without signs of primary irritation after epicutaneous administration according to the range finding test. Therefore a separate challenge control is not necessary.
- Positive control substance(s):
- yes
- Remarks:
- DNCB
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1 % in vehicle
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1 % in vehicle. No with. + reactions: 1.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1 % in vehicle
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1 % in vehicle. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- undiluted vehicle
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: undiluted vehicle. No with. + reactions: 1.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- undiluted vehicle
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: undiluted vehicle. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 1 % in Oleum arachidis
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 1 % in Oleum arachidis. No with. + reactions: 10.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 1 % in Oleum acharidis
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 1 % in Oleum acharidis. No with. + reactions: 10.0. Total no. in groups: 10.0.
Any other information on results incl. tables
Results of the Range finding test:
dermal(test sample diluted with oleum arachidis):
Animal No. |
sex |
Concentration |
24 h |
48 h |
|
|
|
|
|
1 |
male |
100 % |
1 |
2 |
2 |
female |
100 % |
2 |
2 |
|
|
|
|
|
1 |
male |
10 % |
1 |
1 |
2 |
female |
10 % |
1 |
1 |
|
|
|
|
|
1 |
male |
5 % |
0 |
0 |
2 |
female |
5 % |
1 |
0 |
|
|
|
|
|
1 |
male |
2.5 % |
0 |
0 |
2 |
female |
2.5 % |
1 |
0 |
|
|
|
|
|
1 |
male |
1 % |
0 |
0 |
2 |
female |
1 % |
0 |
0 |
intradermal(test sample diluted with oleum arachidis):
Animal No. |
sex |
10 % le. + ri. |
5 % le. + ri. |
2.5 % le. + ri. |
1 % le. + ri. |
|
|
|
|
|
|
1 |
male * |
2 |
2 |
1 |
1 |
2 |
female * |
2 |
2 |
1 |
1 |
* 48 h post application the diameter of erythema was 8 mm.
Results of the Main Study:
Induction - intradermal:
Test group:
24 h p.a. slight to distinct erythemas and slight swellings were observed on the test group areas (test substance 10 %). These signs decreased distinctly until the next days p.a., so that from the 7thday p.a. (= day of dermal treatment) no more findings were recorded.
The areas treated with the test substance + FCA and those treated only with FCA showed more or less distinct erythema and swelling. From the 5 - 6thday p.a. these injection areas of all animals were burst open. From the 9thday p.a. a healing up of the areas was recorded, so that at termination of the study all injection areas were completely healed up.
Control group:
On the areas of the control group (vehicle undiluted), only treated with the vehicle partly very slight erythemas and swellings were found, which decreased distinctly the following days so that on day 7 p.a. no more findings were observed.
The areas treated with the vehicle + FCA and those treated only with FCA showed more or less distinct erythema and swelling. From the 5 - 6thday p.a. these injection areas of all animals were burst open. From the 9thday p.a. a healing up of the areas was recorded, so that at termination of the study all injection areas were completely healed up.
Summary of response after intradermal induction treatment:
Group |
area |
day 1 - 6 |
day 7 |
day 9 |
termination |
Test group |
T |
Erytema scoring: 1 – 2 Ø 9 – 10 mm, slight swelling |
20/20 plane, n. sp. f. |
n. sp. f. |
n. sp. f. |
T + FCA |
Erytema scoring: 1 – 2 Ø 9 – 10 mm, swelling |
13/20 eschar 20/20 area bursted |
16/20 area bursted eschar |
areas closed |
|
FCA |
Erytema scoring: 1 – 2 Ø 9 – 10 mm, swelling |
20/20 area bursted |
17/20 area bursted eschar |
areas closed |
|
Control group |
V |
Erytema scoring: 0 – 1 Ø 0 – 6 mm, 16/20 plane |
20/20 plane, n. sp. f. |
n. sp. f. |
n. sp. f. |
V + FCA |
Erytema scoring: 1 – 2 Ø 8 – 10 mm, slight swelling |
20/20 area bursted |
14/20 area bursted eschar |
areas closed |
|
FCA |
Erytema scoring: 2 Ø 8 – 10 mm, slight swelling |
20/20 area bursted |
16/20 area bursted eschar |
areas closed |
T = Test sample (10 %) *… / 20 = of treated animals (areas)
V = Vehicle (undiluted) n. sp. f. = no specific findings
FCA = Freund’s Complet Adjuvant
Induction - dermal:
Due to the above mentioned findings after the intradermal treatment an evaluation of findings was not possible in the animals.
Challenge - dermal:
24 h after challenge slight erythema was observed in 1/20 animals of the test group and 1/20 animals in the control group. 24 h later this erythema had completely disappeared. Since this finding, which was both slight and transitory, was evident in only 1 of the 20 animals in the test group and in the control group, it is not attributed any biological significance.
The control areas of both groups showed no findings at both time points.
Individual values after dermal treatment (induction and challenge):
Test group |
Induction Test sample 10 % in Ol. arachidis |
Challenge right flank: 0.5 ml Ol. acharidis left flank: 0.5 ml 1 % Test sample in Ol. arachidis |
|
|||||
Animal |
sex |
BW (g) |
day 1-6 p.a. |
24 hours, flank |
48 hours, flank |
BW (g) |
||
No. |
|
start |
|
ri. |
le. |
ri. |
le. |
end |
1 |
m |
312 |
* |
0 |
0 |
0 |
0 |
494 |
2 |
m |
321 |
* |
0 |
0 |
0 |
0 |
502 |
3 |
m |
323 |
* |
0 |
0 |
0 |
0 |
464 |
4 |
m |
315 |
* |
0 |
0 |
0 |
0 |
482 |
5 |
m |
318 |
* |
0 |
0 |
0 |
0 |
496 |
6 |
m |
308 |
* |
0 |
0 |
0 |
0 |
447 |
7 |
m |
310 |
* |
0 |
0 |
0 |
0 |
487 |
8 |
m |
319 |
* |
0 |
1 |
0 |
0 |
529 |
9 |
m |
312 |
* |
0 |
0 |
0 |
0 |
499 |
10 |
m |
300 |
* |
0 |
0 |
0 |
0 |
463 |
11 |
f |
303 |
* |
0 |
0 |
0 |
0 |
433 |
12 |
f |
286 |
* |
0 |
0 |
0 |
0 |
432 |
13 |
f |
287 |
* |
0 |
0 |
0 |
0 |
433 |
14 |
f |
293 |
* |
0 |
0 |
0 |
0 |
427 |
15 |
f |
293 |
* |
0 |
0 |
0 |
0 |
468 |
16 |
f |
328 |
* |
0 |
0 |
0 |
0 |
468 |
17 |
f |
301 |
* |
0 |
0 |
0 |
0 |
437 |
18 |
f |
265 |
* |
0 |
0 |
0 |
0 |
379 |
19 |
f |
296 |
* |
0 |
0 |
0 |
0 |
402 |
20 |
f |
283 |
* |
0 |
0 |
0 |
0 |
401 |
Control group |
Induction Ol. arachidis undiluted |
Challenge right flank: 0.5 ml Ol. acharidis left flank: 0.5 ml 1 % Test sample in Ol. arachidis |
|
|||||
Animal |
sex |
BW (g) |
day 1-6 p.a. |
24 hours, flank |
48 hours, flank |
BW (g) |
||
No. |
|
start |
|
ri. |
le. |
ri. |
le. |
end |
1 |
m |
318 |
* |
0 |
0 |
0 |
0 |
466 |
2 |
m |
374 |
* |
0 |
0 |
0 |
0 |
468 |
3 |
m |
339 |
* |
0 |
0 |
0 |
0 |
524 |
4 |
m |
370 |
* |
0 |
0 |
0 |
0 |
509 |
5 |
m |
345 |
* |
0 |
0 |
0 |
0 |
516 |
6 |
m |
327 |
* |
0 |
0 |
0 |
0 |
520 |
7 |
m |
360 |
* |
0 |
0 |
0 |
0 |
526 |
8 |
m |
331 |
* |
0 |
0 |
0 |
0 |
502 |
9 |
m |
364 |
* |
0 |
1 |
0 |
0 |
547 |
10 |
m |
322 |
* |
0 |
0 |
0 |
0 |
460 |
11 |
f |
300 |
* |
0 |
0 |
0 |
0 |
423 |
12 |
f |
322 |
* |
0 |
0 |
0 |
0 |
428 |
13 |
f |
327 |
* |
0 |
0 |
0 |
0 |
426 |
14 |
f |
300 |
* |
0 |
0 |
0 |
0 |
449 |
15 |
f |
277 |
* |
0 |
0 |
0 |
0 |
383 |
16 |
f |
315 |
* |
0 |
0 |
0 |
0 |
433 |
17 |
f |
311 |
* |
0 |
0 |
0 |
0 |
417 |
18 |
f |
281 |
* |
0 |
0 |
0 |
0 |
405 |
19 |
f |
267 |
* |
0 |
0 |
0 |
0 |
379 |
20 |
f |
311 |
* |
0 |
0 |
0 |
0 |
401 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information
- Conclusions:
- Citrowanil B does not have sensitising properties.
- Executive summary:
The experimental design was performed according to the method of B. Magnusson and A.M. Kligman (OECD / EEC-guidelines).
To test the sensitising properties of the compound 20 test- and 20 control-animals (guinea-pigs) were treated with 10 % of the test compound during the induction phases (intradermal and dermal) and with 1 % for the challenge (dermal) using Freund's Complet Adjuvant (FCA) to intensify the immunological reaction.
Any signs of erythema and edema were recorded 24 h and 48 h after the challenge.
According to the method of B. Magnusson and A.M. Kligman (OECD / EEC-guidelines), the compound "CITROWANIL B" is considered not to cause any hypersensitivity in guinea-pigs.
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