Registration Dossier
Registration Dossier
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EC number: 603-094-7 | CAS number: 125904-11-2
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 30 September to 12 November 1986
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- At the time the study was performed, a lower number of treated animals was required for non-adjuvant studies. As the number of induction exposures was higher than the normally used, and response in treated animals was clear, this deviation is considered to not affect the outcome of the study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1981
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- The testing using the guinea pig maximisation test protocol was completed on 30 September 1986. The LLNA 429 was not formally adopted by the OECD until 22 July 2010.
Test material
- Reference substance name:
- Benzene, dibromoethyl Benzene, ethenyl-, ar-bromo derivs.
- EC Number:
- 603-094-7
- Cas Number:
- 125904-11-2
- Molecular formula:
- C8 H6 Br2
- IUPAC Name:
- Benzene, dibromoethyl Benzene, ethenyl-, ar-bromo derivs.
- Test material form:
- liquid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Kuiper's Rabbit Ranch, Gary, Indiana, USA
- Age at study initiation: young adult
- Weight at study initiation (main study): 333 to 445 g
- Housing: individual in wire-mesh cages suspended above cage board
- Diet: Purina Certified Guinea Chow #5026 or Purina Certified Rabbit Chow #5322 supplemented three times a week with fresh apples ad libitum
- Water: tap water from on-site weels ad libitum
- Acclimation period: at least 14 days
ENVIRONMENTAL CONDITIONS
- Temperature: 72 +/- 4 Fahrenheit degrees
- Humidity: 40% or more
- Photoperiod: 12 hours light/12 hours dark
IN-LIFE DATES: 30 September to 12 November 1986
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: acetone
- Concentration / amount:
- 25% for inductions (treated animals only) and 5% for challenge (treated and naive control animals)
0.25 (first 3 inductions) and 0.1% (w/v) in 80% ethanol for inductions (positive control animals) and 0.1% in 80% ethanol for challenge (positive control animals)
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: acetone
- Concentration / amount:
- 25% for inductions (treated animals only) and 5% for challenge (treated and naive control animals)
0.25 (first 3 inductions) and 0.1% (w/v) in 80% ethanol for inductions (positive control animals) and 0.1% in 80% ethanol for challenge (positive control animals)
- No. of animals per dose:
- 6 males and 6 females for the treated group,
3 males and 3 females for the naive and positive control groups - Details on study design:
- A total of 9 Induction exposures were performed on treated animals, each 2-3 days apart.
- Challenge controls:
- Naive control animals remained untreated during the induction phase. They were challenged with Dibromostyrene at 5% in acetone as the treated animals.
- Positive control substance(s):
- yes
- Remarks:
- 1-chloro-2,4-dinitrobenzene
Results and discussion
- Positive control results:
- All positive control animals exhibited sensitization responses at challenge, ranging from slight (grade 1) to severe (grade 3).
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5% in acetone
- No. with + reactions:
- 2
- Total no. in group:
- 12
- Clinical observations:
- very slight reaction (grade +/-)
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5% in acetone. No with. + reactions: 2.0. Total no. in groups: 12.0. Clinical observations: very slight reaction (grade +/-).
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5% in acetone
- No. with + reactions:
- 5
- Total no. in group:
- 12
- Clinical observations:
- very slight reaction (grade +/-)
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5% in acetone. No with. + reactions: 5.0. Total no. in groups: 12.0. Clinical observations: very slight reaction (grade +/-).
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 5% in acetone
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 5% in acetone. No with. + reactions: 0.0. Total no. in groups: 6.0.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 5% in acetone
- No. with + reactions:
- 1
- Total no. in group:
- 6
- Clinical observations:
- very slight reaction (grade +/-)
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 5% in acetone. No with. + reactions: 1.0. Total no. in groups: 6.0. Clinical observations: very slight reaction (grade +/-).
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 1% in 80% ethanol
- No. with + reactions:
- 6
- Total no. in group:
- 6
- Clinical observations:
- grades 1 to 3
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 1% in 80% ethanol. No with. + reactions: 6.0. Total no. in groups: 6.0. Clinical observations: grades 1 to 3.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 1% in 80% ethanol
- No. with + reactions:
- 6
- Total no. in group:
- 6
- Clinical observations:
- grades 1 to 3
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 1% in 80% ethanol. No with. + reactions: 6.0. Total no. in groups: 6.0. Clinical observations: grades 1 to 3.
Any other information on results incl. tables
The Irritation Severity Index was also calculated for each group at each time point. At 24 hours the irritation severity index was 0.1, 0.0 and 1.8 in the treated, negative and positive control groups, respectively. At 48 hours the irritation severity index was 0.2, 0.1 and 1.8 in the treated, negative and positive control groups, respectively.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- The test substance failed to reveal skin sensitization potential at challenge, following 9 exposure inductions, in a Buheler test.
- Executive summary:
In a Buheler test, a group consisting of 6 male and 6 female Hartley albino guinea pigs was induced by topical application of the test substance at 25% in acetone for 9 times, 2 -3 days apart one from the other. The test material induced generally very slight to slight (grade +/- to grade 1) reactions during the induction phase, the incidence and severity of which increased as induction treatment progressed. Other findings of fissuring, desquamation and scabbing were noted during the induction phase. Treated and negative control animals were therefore challenged with the test substance at 5% in acetone applied to a previously unexposed area of skin. Only very slight reactions (grade +/-) were observed in 2 treated and 0 negative control animals at the 1st reading 24 hours after challenge. Very slight reactions (grade +/-) were observed in 5 treated and 1 negative control animals at the 2nd reading 48 hours after challenge. All the positive control animals showed evidence of skin sensitisation at both the 24 and 48 hours readings (grades 1 to 3), demonstrating test system sensitivity and appropriateness of the test method.
On these bases the test substance was considered to not be a skin sensitizer.
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