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EC number: 418-480-9 | CAS number: 138526-69-9 1-BROM-3,4,5-TRIFLUORBENZOL; 1-BROMO-3,4,5-TRIFLUOROBENZENE
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 07-1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- not further specified
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study performed in 1995
Test material
- Reference substance name:
- 1-bromo-3,4,5-trifluorobenzene
- EC Number:
- 418-480-9
- EC Name:
- 1-bromo-3,4,5-trifluorobenzene
- Cas Number:
- 138526-69-9
- Molecular formula:
- Hill formula: C6H2BrF3 CAS formula: C6H2BrF3
- IUPAC Name:
- 5-bromo-1,2,3-trifluorobenzene
- Test material form:
- liquid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: David Hall Ltd., Burton-on-Trent, UK
- Age at study initiation: 8 – 12 weeks
- Weight at study initiation: 360 – 427 g
- Housing: singly or in pairs in solid-floor PP cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 – 23
- Humidity (%): 48 – 68
- Photoperiod (hrs dark / hrs light): 12 hour light - 12 hour dark regime
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- arachis oil
- Concentration / amount:
- 0.1 mL of 25 % (w/v) in arachis oil B.P., 25 % (w/v) in a mixture of Freund's Complete Adjuvant plus distilled water (1:1)
- Day(s)/duration:
- day 0
- 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:
- Filter patch saturated with the undiluted test material
- Day(s)/duration:
- Application on day 7 over 48 hours
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- arachis oil
- Concentration / amount:
- Filter patch saturated with the undiluted test material (100 and 75% (v/v))
- Day(s)/duration:
- day 21 over 24 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Number of animals in test group: 10
Number of animals in negative control group: 5 - Details on study design:
- RANGE FINDING TESTS: The concentrations for the main study were determined by 'sighting tests' in which groups of guinea pigs were treated with various concentrations of test material.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and topical)
- Test groups:
a) Freund's Complete Adjuvant plus distilled water in the ratio 1:1
b) a 25% w/v formulation of the test material in arachis oil B.P.
c) a 25% w/v formulation of the test material in a 1:1 preparation of Freund's Complete Adjuvant plus distilled water.
One week later (Day 7), the same area on the shoulder region used previously for intradermal injections was clipped again and treated with a topical application of the undiluted test material. A filter paper patch saturated with the undiluted test material was applied to the prepared skin and held in place with a strip of surgical adhesive tape covered with an overlapping length of aluminium foil. This occlusive dressing was kept in place for 48 hours.
- Control group:
a) Freund's Complete Adjuvant plus distilled water in the ratio 1:1
b) arachis oil B.P.
c) 50% w/v formulation of arachis oil B.P. in a 1:1 mixture of Freund's Complete Adjuvant/distilled water
The topical applications followed the same procedure as for the test animals except that nothing was applied to the filter paper. Skin reactions were quantified as for the test animals.
B. CHALLENGE EXPOSURE
- No. of exposures: 1 (topical)
- Day(s) of challenge: 21
- Exposure period: 24 h
- Test groups:
A square filter paper patch, saturated with the undiluted test material was applied to the shorn right flank of each animal and was held in place with a strip of surgical adhesive tape. To ensure that the maximum non-irritant concentration was used at challenge, the test material at a concentration of 75% v/v in arachis oil B.P. was similarly applied to a skin site on the left shorn flank. The patches were occluded with an overlapping length of aluminium foil and secured with a strip of elastic adhesive bandage wound in a double layer around the torso of each animal.
After 24 hours, the dressing was carefully cut using blunt-tipped scissors, removed and discarded. The challenge sites were swabbed with cotton wool soaked in diethyl ether to remove residual material. The position of the treatment sites was identified by using a black indelible marker-pen. Prior to the 24-hour observation the flanks were clipped using veterinary clippers to remove regrown hair. - Challenge controls:
- yes
- Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 75 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 75 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 75 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 75 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Group:
- positive control
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
Bodyweight
Bodyweight gains-of guinea pigs in the test group, between Day 0 and Day 24, were comparable to those observed in the control group animals over the same period.
Positive control
SUMMARY OF POSITIVE CONTROL DATA FOR THE MAGNUSSON AND KLIGMAN MAXIMISATION STUDY (NOVEMBER 1993 TO NOVEMBER 1994)
Project |
Date Start |
Date |
Number of Animals |
Positive Control Material |
concentration |
Challenge |
Incidence of |
||
|
|
|
Test |
Control |
|
Intradermal |
Topical |
|
|
039/62 |
19/10/93 |
12/11/93 |
10 Female |
5 Female |
alpha-hexylcinnamaldehyde Tech. |
25% in arachis |
100% |
100% and |
70% (7/10) |
039/70 |
01/03/94 |
25/03/94 |
10 |
5 Female |
2-Mercaptobenzothiazole |
10% in arachis |
50% in 95% |
25% in 95% |
80% (8/10) |
039/85 |
13/07/94 |
06/08/94 |
18 |
10 Female |
Ethyl 4 aminobenzoate 98% |
3% in a 6% acetone in |
25% in 80% |
10% and 5% |
39% (7/18) |
039/108 |
31/10/94 |
24/11/94 |
9 |
5 |
2,4-Dinilrochlorobenzene |
0.1 % in arachis |
1 % in arachis |
0.1% and |
100% (9/9) |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of this study the test item can be assessed as a non sensitiser to guinea pig skin.
- Executive summary:
The purpose of this GLP study performed according to OECD TG 406 was to assess the contact sensitisation potential of the test material in the albino guinea pig. Based on the results of sighting tests, the concentrations of test material for the induction and challenge phases were selected as follows:
Intradermal induction: 25 % (w/v) in arachis oil B.P.
Topical induction: undiluted as supplied
Topical challenge: 100 and 75% (v/v) in arachis oil B.P.
Skin reactions after intradermal induction: Well-defined to moderate to severe erythema was noted at all induction sites at the 24 and 48-hour observations in the test group animals. Very slight erythema was noted at all treatment sites at the 24-hour observation and one treatment site at the 48-hour observation in the control group animals.
Skin reactions after topical induction: Very slight erythema was noted at eight induction sites at the 1-hour observation with no dermal reactions at the 24-hour observation in the test group animals. No dermal reactions were noted at the 1 or 24-hour observations at the treatment sites of the control group animals.
Skin reactions after topical challenge: No skin reactions were noted at the challenge sites of the test or control group animals at the 24 or 48-hour observations at the 100% or 75% concentrations.
Bodyweight gains of guinea pigs in the test group, between days 0 – 24, were comparable to those observed in the control group animals over the same period.
The test item produced a 0 % (0/10) sensitisation rate in guinea pigs.
Based on the results of this study the test item can be assessed as a non sensitiser to guinea pig skin.
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