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EC number: 203-691-9 | CAS number: 109-65-9
- 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
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- Nanomaterial pour density
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- 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:
- 18 January 1996 to 12 February 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- O.E.C.D. guideline No. 406, 17th July 1992
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- E.C. Directive No. 92/69/E.E.C., B6, 31st July 1992.
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Available study data is over 12 years old.
Test material
- Reference substance name:
- 1-bromobutane
- EC Number:
- 203-691-9
- EC Name:
- 1-bromobutane
- Cas Number:
- 109-65-9
- Molecular formula:
- C4H9Br
- IUPAC Name:
- 1-bromobutane
- Test material form:
- liquid
- Details on test material:
- name:
protocol and labelling: n-BUTYL BROMIDE
batch number:
protocol and labelling: 5-241-1 / 0-201-1
Elf Atochem filing number: CAL 6777/95
description: colourless liquid
quantity and container: 150 gin one glass flask
date of receipt: 19.12.95
storage conditions: at room temperature and protected from light
purity: 99.8%.
Constituent 1
- Specific details on test material used for the study:
- No further details specified in the study report.
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- Species and strain: Dunkin-Hartley guinea-pigs.
Reason for this choice: species recommended by the international regulations for sensitization studies. The strain used has been shown to produce a satisfactory sensitization response using known positive sensitizers.
Breeder: Centre d'Elevage Lebeau, 78950 Gambais, France.
Number: 30 animals (15 males and 15 nulliparous and non-pregnant females).
Allocation of the animals to the groups: on day -1, the animals were weighed and randomly allocated to two groups: a control group 1 consisting of ten animals (five males and five females) and a treated group 2 consisting of 20 animals (ten males and ten females).
Weight: on day 1, the animals were approximately three months old and had a mean body weight ± standard deviation of 422 ± 20 g for the males and 407 ± 22 g for the females.
Acclimatization: at least five days before the beginning of the study.
Identification of the animals: ear-tattoo.
Environmental conditions
During the acclimatization period and throughout the study, the conditions in the animal room were set as follows:
Temperature: 21 ± 2 °C
Relative humidity: 30 to 70%
Light/dark cycle: 12 h/12 h
Ventilation: about 12 cycles/hour of filtered, non-recycled air.
The temperature and relative humidity were recorded continuously and records retained.
The housing conditions (temperature, relative humidity and ventilation) were checked monthly.
During the acclimatization period and throughout the study, the animals were housed individually in polycarbonate cages (48 cm x 27 cm x 20 cm) equipped with a polypropylene bottle.
Dust-free sawdust was provided as litter (SICSA, 92142 Alfortville, France).
Bacteriological analysis of the sawdust and detection of possible contaminants (pesticides, heavy metals) are performed periodically.
Food and water
During the study, the animals had free access to "106 diet" (U.A.R., 91360 Villemoisson-surOrge, France).
Each batch of food was analysed (composition and contaminants) by the supplier.
Drinking water filtered by a F.G. Millipore membrane (0.22 micron) was provided ad libitum.
Bacteriological and chemical analysis of the water and diet and detection of possible contaminants (pesticides, heavy metals and nitrosamines) are performed periodically.
It was verified that no contaminants in the diet or water at levels likely to influence the outcome of the study were present.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- paraffin oil
- Concentration / amount:
- 25% (w/w)
- Day(s)/duration:
- Day 1/7 days
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100%
- Day(s)/duration:
- Day 8/48 hours
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- 50% (w/w) - left flank
- Day(s)/duration:
- Day 22/48 hours
- Adequacy of challenge:
- highest non-irritant concentration
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- 25% (w/w) - right flank
- Day(s)/duration:
- Day 22/48 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Thirty guinea-pigs were allocated to two groups: a control group 1 (five males and five females) and a treated group 2 (ten males and ten females).
- Details on study design:
- Preliminary test
A preliminary test was conducted in order to determine the concentrations to be tested in the main study.
By intradermal route:
24 hours before treatment, the dorsal region of the animals was clipped, the test substance was prepared in an appropriate vehicle, intradermal administrations of the test substance (0.1 ml) at different concentrations were performed in the dorsal region between the shoulders, cutaneous reactions were evaluated approximately 24, 48 hours and six days after injection.
By cutaneous route:
24 hours before treatment, both flank regions of the animals were clipped, if necessary, the test substance was prepared in an appropriate vehicle, the test substance (0.5 ml for each concentration) was applied to a dry gauze pad of approximately 4 cm2 which was held in place by an occlusive dressing for 24 hours, cutaneous reactions were evaluated approximately 24 and 48 hours after removal of the dressings.
Criteria for selection of concentrations
The following criteria were used:
-the concentrations should be well-tolerated systemically and locally,
-intradermal injections should cause moderate irritant effect (no necrosis or ulceration of the skin),
-topical application for the induction should cause at most weak or moderate skin reactions or be the maximal practicable concentration,
-topical application for the challenge should be the highest concentration which does not cause irritant effect.
Main study
Preparation of the animals
For all animals and before each treatment, the application sites were:
-clipped on days -l and 7 (scapular area 4 cm x 2 cm),
-clipped and shaved on day 21 (each flank 2 cm x 2 cm).
Induction phase by intradermal and cutaneous routes
Intradermal route
On day 1, six injections were made deep into the dermis of a clipped area (4 cm x 2 cm) in the dorsal region between the shoulders, using a needle (diameter: 0.50 x 16 mm, Terumo: C.M.L., 77140 Nemours, France) mounted on a 1 ml glass syringe (0.01 ml graduations, Record: Carrieri, 75005 Paris, France).
Cutaneous route
On day 7, the scapular area was clipped.
As the test substance was shown to be irritant during the preliminary tests, a topical application with sodium laurylsulphate was not necessary on day 7.
On day 8, a topical application to the region of the intradermal injections (4 cm x 2 cm) was performed.
Control group
-application of 0.5 ml of the vehicle.
Treated group
-application of 0.5 ml of the test substance at the chosen concentration.
The test substance and the vehicle were prepared on a dry gauze pad (Semes France, 54183 Heillecourt, France), which was then applied to the dorsal region between the shoulders and held in place for 48 hours by means of an adhesive hypoallergenic dressing (Laboratoires de Pansements et d'Hygiene, 21300 Chenove, France) and an adhesive anallergenic waterproof plaster (Laboratoire des Professions Medicales, 92240 Malakoff, France).
On removal of the dressing, if present, any residual test substance was removed by means of a dry or a moistened gauze pad.
Cutaneous reactions were recorded one hour after removal of the occlusive dressing.
Challenge phase
On day 22, the animals from both groups received an application of 0.5 ml of the test substance at a concentration of 25% (w/w) to the posterior right flank, and 0.5 ml of the test substance at a concentration of 50% (w/w) to the posterior left flank. This application was performed using a 1 ml plastic syringe (0.01 ml graduations, Terumo: C.M.L., 77140 Nemours, France). The test substance and vehicle were prepared on a dry gauze pad (Semes France, 54183 Heillecourt, France), then applied to a 4 cm2 (2 cm x 2 cm) clipped area of the skin. The gauze pad was held in contact with the skin for 24 hours by means of an occlusive, hypoallergenic dressing (Laboratoires de Pansements et d'Hygiene, 21300 Chenove, France) and an adhesive anallergenic waterproof plaster (Laboratoire des Professions Medicales, 92240 Malakoff, France).
On removal of the dressing, if present, any residual test substance was removed by means of a dry or a moistened gauze pad.
CLINICAL EXAMINATIONS
The animals were observed twice a day during the study in order to check for clinical signs and mortality.
BODY WEIGHT
The animals were weighed individually on the day of allocation into the groups, on the first day of the study (day 1), on days 8 and 15 and on the last day of the study.
PATHOLOGY
Necropsy
Macroscopic examination of the main organs was performed on the animal found dead during the study.
At the end of the study, all the surviving animals were killed by CO, inhalation in excess. No necropsy was performed.
Cutaneous samples
No skin samples were taken.
Microscopic examination
No histological examinations were performed. - Positive control substance(s):
- yes
- Remarks:
- 2,4-dinitro chlorobenzene.
Results and discussion
- Positive control results:
- The guinea-pigs which were used in a recent study, showed a satisfactory sensitization response in 100% animals using a positive sensitizer.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50% (w/w) - left flank
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25% (w/w) - right flank
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50% (w/w) - left flank
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25% (w/w) - right flank
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50% (w/w) - left flank
- No. with + reactions:
- 3
- Total no. in group:
- 19
- Clinical observations:
- At the 24-hour reading, very slight erythema (grade 1) was observed in 3/19 and 2/19 animals treated with 50% and 25% (w/w) of the test substance, respectively.
- Remarks on result:
- other: Since skin irritation was noted in the preliminary assay, with the undiluted test substance, these very faint and transient skin reactions were attributed to irritant properties of the test substance.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25% (w/w) - right flank
- No. with + reactions:
- 2
- Total no. in group:
- 19
- Clinical observations:
- At the 24-hour reading, very slight erythema (grade 1) was observed in 3/19 and 2/19 animals treated with 50% and 25% (w/w) of the test substance, respectively.
- Remarks on result:
- other: Since skin irritation was noted in the preliminary assay, with the undiluted test substance, these very faint and transient skin reactions were attributed to irritant properties of the test substance.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50% (w/w) - left flank
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Clinical observations:
- No skin reactions were observed at the 48-hour reading.
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25% (w/w) - right flank
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Clinical observations:
- No skin reactions were observed at the 48-hour reading.
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
PRELIMINARY STUDY
Administration by intradermal route
Several test were performed in order to determine the concentration to be used in the main study.
Animal number |
Concentration of the test substance % (w/w) |
Scoring after treatment |
||
24 hours |
48 hours |
6 days |
||
Male 01 |
10 25 50 |
Irritation Irritation Necrosis |
Irritation Irritation Necrosis |
Irritation Irritation Crusts |
Female 01 |
10 25 50 |
Irritation Irritation Necrosis |
Irritation Irritation Necrosis |
Irritation Irritation Crusts |
Concentration chosen for the main study was 25% (w/w).
Application by cutaneous route
One test was performed in order to check if the undiluted compound was irritant.
Animal number |
Concentration of the test substance % |
|
Scoring after removal of the dressing(1) |
|||
24 hours |
48 hours |
|||||
E |
O |
E |
O |
|||
Male 01 |
100 100 |
RF LF |
1 1 |
0 0 |
1 1 |
0 0 |
Female 01 |
100 100 |
RF LF |
1 1 |
0 0 |
1 1 |
0 0 |
Male 02 |
50 (w/w) 50 (w/w) |
RF LF |
0 0 |
0 0 |
0 0 |
0 0 |
Female 03 |
50 (w/w) 50 (w/w) |
RF LF |
0 0 |
0 0 |
0 0 |
0 0 |
E: Erythema
O: Oedema
RF: Right flank
LF: left flank
(1): No residual test substance was observed.
Concentration chosen for the topical application of the induction phase (day 8) was 100%.
For the challenge application, it was 25% (w/w) for the right flank and 50% (w/w) for the left flank.
MAIN STUDY
Clinical examinations
No clinical signs were observed during the study.
One male of the treated group (No. 14) was found dead on day 18. Spontaneous mortality are often observed in guinea-pigs and this mortality was not attributed to treatment.
The body weight gain of the treated animals was normal when compared to that of the control animals.
Scoring of cutaneous reactions
End of the induction period
On day 10, after topical application of the induction period, signs of irritation were observed at the test site (dorsal region between shoulders) in the control and treated groups.
Challenge application
NO residual test substance was observed after removal of the dressing.
Skin reactions were as follows:
Sex |
Animal number |
Control group |
|||||||
24 hours |
48 hours |
||||||||
Erythema |
Oedema |
Erythema |
Oedema |
||||||
LF |
RF |
LF |
RF |
LF |
RF |
LF |
RF |
||
Male |
01 02 03 04 05 |
0 0 0 0 0 |
0 0 0 0 0 |
0 0 0 0 0 |
0 0 0 0 0 |
0 0 0 0 0 |
0 0 0 0 0 |
0 0 0 0 0 |
0 0 0 0 0 |
Female |
16 17 18 19 20 |
0 0 0 0 0 |
0 0 0 0 0 |
0 0 0 0 0 |
0 0 0 0 0 |
0 0 0 0 0 |
0 0 0 0 0 |
0 0 0 0 0 |
0 0 0 0 0 |
LF: left flank (test substance at a concentration of 50% (w/w))
RF: right flank (test substance at a concentration of 25% (w/w))
Sex |
Animal number |
Treated group |
|||||||
24 hours |
48 hours |
||||||||
Erythema |
Oedema |
Erythema |
Oedema |
||||||
LF |
RF |
LF |
RF |
LF |
RF |
LF |
RF |
||
Male |
06 07 08 09 10 11 12 13 14 15 |
0 0 1 0 0 1 0 0 - 1 |
0 0 1 0 0 0 0 0 - 1 |
0 0 0 0 0 0 0 0 - 0 |
0 0 0 0 0 0 0 0 - 0 |
0 0 0 0 0 0 0 0 - 0 |
0 0 0 0 0 0 0 0 - 0 |
0 0 0 0 0 0 0 0 - 0 |
0 0 0 0 0 0 0 0 - 0 |
Female |
21 22 23 24 25 26 27 28 29 30 |
0 0 0 0 0 0 0 0 0 0 |
0 0 0 0 0 0 0 0 0 0 |
0 0 0 0 0 0 0 0 0 0 |
0 0 0 0 0 0 0 0 0 0 |
0 0 0 0 0 0 0 0 0 0 |
0 0 0 0 0 0 0 0 0 0 |
0 0 0 0 0 0 0 0 0 0 |
0 0 0 0 0 0 0 0 0 0 |
LF: left flank (test substance at a concentration of 50% (w/w))
RF: right flank (test substance at a concentration of 25% (w/w))
-: dead animal
At the 24-hour reading, very slight erythema (grade 1) was observed in 3/19 and 2/19 animals treated with 50% and 25% (w/w) of the test substance, respectively.
No skin reactions were observed at the 48-hour reading.
Since skin irritation was noted in the preliminary assay, with the undiluted test substance, these faint and transient skin reactions were attributed to irritant properties of the test substance.
Pathology
Necropsy
Macroscopic examination of the main organs of the animal No. 14, found dead during the study, revealed no apparent abnormalities.
Microscopic examination
No microscopic examinations were performed.
INDIVIDUAL BODY WEIGHT VALUES
(g)
Groups |
Sex |
Animals |
Days |
|||||||
-1 |
1 |
(1) |
8 |
(1) |
15 |
(1) |
25 |
|||
1 |
Male |
01 02 03 04 05
M SD |
432 436 411 400 418
419 15 |
426 438 414 408 433
424 13 |
87 86 113 91 52
86 22 |
513 524 527 499 485
510 18 |
53 32 11 -6 8
20 23 |
566 556 538 493 493
529 35 |
11 -64 -28 43 -4
-8 40 |
577 492 510 536 489
521 37 |
Female |
16 17 18 19 20
M SD |
394 418 413 395 435
411 17 |
401 404 413 389 438
409 18 |
109 83 70 92 86
88 14 |
510 487 483 481 524
497 19 |
-14 -26 21 -42 6
-11 25 |
496 461 504 439 530
486 36 |
6 72 0 54 -8
25 36 |
502 533 504 493 522
511 16 |
|
2 |
Male |
06 07 08 09 10 11 12 13 14 15
M SD |
418 448 438 397 429 458 409 384 431 385
420 26 |
420 453 434 403 422 453 408 385 435 399
421 23 |
89 53 65 52 30 84 87 53 66 72
65 19 |
509 506 500 455 452 537 495 438 501 471
486 31 |
77 4 51 45 22 35 -20 40 -96 -14
14 49 |
586 510 551 500 474 572 475 478 405 457
501 56 |
-58 41 -21 -3 64 -14 101 26
71
23 51 |
528 551 530 497 538 558 576 504
528
534 25 |
Female |
21 22 23 24 25 26 27 28 29 30
M SD |
395 400 394 442 383 412 432 403 420 361
404 24 |
399 409 396 443 383 426 418 396 428 362
406 24 |
66 73 84 43 70 70 43 81 86 62
68 15 |
465 482 480 486 453 496 461 477 514 424
474 25 |
0 1 14 36 11 -2 -11 33 36 31
15 18 |
465 483 494 522 464 494 450 510 550 455
489 32 |
22 41 16 -3 68 -5 57 22 -31 -7
18 31 |
487 524 510 519 532 489 507 532 519 448
507 26 |
(1) = body weight gain
M = Mean
SD = Standard Deviation
Animal found dead during the study not mentioned
Positive control to check the sensitivity of Dunkin-Hartley guinea-pigs
Test substance: 2,4-dinitro chlorobenzene
Number of animals: ten males and ten females
Induction: 0.1% intradermal route day 1
1% cutaneous route day 8
Challenge application:1% right flank
Paraffin oil left flank
Conclusion
Under the experimental conditions and according to the Magnusson and Kligman method, 2,4-dinitro chlorobenzene at a concentration of 1% (w/w) induced positive skin sensitization reactions in 100% of the guinea-pigs.
INDIVIDUAL REACTIONS: CHALLENGE PHASE
MACROSCOPIC FINDINGS
Group |
Sex |
Animals |
24-hour |
48-hour |
|
|||||||
Erythema |
Oedema |
Erythema |
Oedema |
Conclusion |
||||||||
LF |
RF |
LF |
RF |
LF |
RF |
LF |
RF |
LF |
RF |
|||
Treated |
Male |
81 82 83 84 85 86 87 88 89 90 |
0 0 0 0 0 0 0 0 0 0 |
1/C 2/S 1 2 2/C/S 1 2/A 2 1 2 |
0 0 0 0 0 0 0 0 0 0 |
0 0 0 2 0 0 2 0 0 4 |
0 0 0 0 0 0 0 0 0 0 |
0/C/S 1/C/S 0/C/S 0/C/S 2/C/A 1/C/S 4/A/C 0/C/S 0/S 2/C/S |
0 0 0 0 0 0 0 0 0 0 |
0 0 0 0 0 0 0 0 0 0 |
- - - - - - - - - - |
+ + + + + + + + + + |
Female |
96 97 98 99 100 101 102 103 104 105 |
0 0 0 0 0 0 0 0 0 0 |
2 1 1/C 2 2 2/A 2/S 2 3 1 |
0 0 0 0 0 0 0 0 0 0 |
2 0 0 0 2 0 0 0 2 0 |
0 0 0 0 0 0 0 0 0 0 |
2/C/S 0/S 0/C/S LS 0/C/S LS/A 2/C/S 2/C/S 4/S LS |
0 0 0 0 0 0 0 0 0 0 |
0 0 0 0 0 0 0 0 2 0 |
- - - - - - - - - - |
+ + + + + + + + + + |
-: negative
+: hypersensitizing reactions
C: yellow colouration of the skin due to the test substance
S: dryness of the skin
A: crusts
LS: scoring masked by a marked dryness of the skin
LF: left flank
RF: right flank
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the experimental conditions and according to the maximization method of Magnusson and Kligman, no cutaneous reactions attributable to the sensitization potential of the test substance n-BUTYL BROMIDE were observed in guinea-pigs.
- Executive summary:
At the request of Elf Atochem S.A., Paris-la-Defense, France, the potential of the test substance n-BUTYL BROMIDE to induce delayed contact hypersensitivity was evaluated in guinea-pigs according to the maximization method of Magnusson and Kligman and to O.E.C.D. (No. 406, 17th July 1992) and E.C. (92/69/E.E.C., B6) guidelines. The study was conducted in compliance with the principles of Good Laboratory Practice Regulations.
Methods
Thirty guinea-pigs were allocated to two groups: a control group 1 (five males and five females) and a treated group 2 (ten males and ten females).
On day 1, in the dorsal region between the shoulders, intradermal injections of Freund's complete adjuvant mixed with the test substance (treated group) or the vehicle (control group) were prepared.
On day 8, this same test site was treated by topical application of the test substance (treated group) or the vehicle (control group) and was covered by an occlusive dressing for 48 hours.
After a rest period of 12 days, all animals of the treated and control groups were challenged by a topical application of the test substance. The right flank received the test substance at a concentration of 25% (w/w), the left flank received the test substance at a concentration of 50% (w/w).
Test substance and vehicle were maintained under an occlusive dressing for 24 hours. Skin reactions were evaluated approximately 24 and 48 hours later.
Test substance concentrations were as follows:
Induction (treated group)
-intradermal injections: n-BUTYL BROMIDE at 25% (w/w) in paraffin oil
-topical application: n-BUTYL BROMIDE at 100%.
Challenge (all groups)
-topical application: n-BUTYL BROMIDE at 50% (w/w) in paraffin oil on the left flank,
-topical application: n-BUTYL BROMIDE at 25% (w/w) in paraffin oil on the right flank.
At the end of the study, animals were killed. No skin samples were taken from the challenge application sites.
The sensitivity of the guinea-pigs in C.I.T. experimental conditions were checked in a recent study with a positive sensitizer: 2,4-dinitro chlorobenzene. During induction period, the test substance was applied at 0.1% (day 1) and 1% (day 8) concentrations. At cutaneous challenge application, 1% (w/w) was tested on the right flank.
Results
No clinical signs and no deaths related to treatment were noted during the study.
No well-defined cutaneous reactions were observed after the challenge application.
The guinea-pigs which were used in a recent study, showed a satisfactory sensitization response in 100% animals using a positive sensitizer.
Conclusion
Under the experimental conditions and according to the maximization method of Magnusson and Kligman, no cutaneous reactions attributable to the sensitization potential of the test substance n-BUTYL BROMIDE were observed in guinea-pigs.
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