Registration Dossier
Registration Dossier
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EC number: 270-695-5 | CAS number: 68476-55-1
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant, guideline study, available as unpublished study report, no restrictions, fully adequate for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Toluene
- EC Number:
- 203-625-9
- EC Name:
- Toluene
- Cas Number:
- 108-88-3
- Molecular formula:
- C7H8
- IUPAC Name:
- toluene
- Details on test material:
- - Name of test material (as cited in study report): CAS 108-88-3, toluene
- Physical state: colourless liquid
- Lot/batch No.: 623889 543
- Stability under test conditions: stable
- Storage condition of test material: room temperature in the dark
- supplier: Merck, Germany
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Albino Himalayan
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: BRL LTD, Basel, Switzerland
- Age at study initiation: approx 6 weeks
- Weight at study initiation: mean 394 g
- Housing: group housing 5 per cage in metal cages with wire mesh floors
- Diet: standard guinea pig diet ad libitum
- Water: ad libitum via automatic system
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 19.5-23.8°C
- Humidity: 34-92%
- Air changes (per hr): 15
- Photoperiod: 12 hrs dark / 12 hrs light
IN-LIFE DATES: From: 22 July 1996 To: 15 August 1996
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- corn oil
- Concentration / amount:
- 10% for intradermal induction, 25 and 50% for challenge
Challengeopen allclose all
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- corn oil
- Concentration / amount:
- 10% for intradermal induction, 25 and 50% for challenge
- No. of animals per dose:
- 20
- Details on study design:
- RANGE FINDING TESTS: intradermal and epidermal irritancy was investigated to select appropriate concentrations for the main study. The selection was based on absence of toxicity and: for induction (intradermal and epidermal) the highest possible concentration that produced moderate irritation and showed no necrosis; for challenge, the maximum non-irritant concentration. Initial concentrations were selected from the series: undiluted, 50%, 20% and 10%, 5%,
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (1 intradermal and 1 epidermal)
- Exposure period: 48 hours for epidermal
- Test groups: Freunds, TS in vehicle, TS in Freunds for intradermal, 0.5 mL TS applied using a Scotchpak-non-woven patch (2 x3 cm) mounted on micropore tape and secured with elastic bandage for epidermal
- Control group: Freunds, vehicle, vehicle in Freunds for intradermal, vehicle for epidermal
- Site: scapular region
- Frequency of applications: intradermal day 1, epidermal day 8
- Concentrations: 10% for intradermal, undiluted for epidermal
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 22
- Exposure period: 24 hours
- Test groups: 0.5mL TS applied using a Scotchpak-non-woven patch (2 x3 cm) mounted on micropore tape and secured with elastic bandage
- Control group: as test
- Site: flank
- Concentrations: 2 (50% and 25%)
- Evaluation (hr after challenge): 24 and 48 hour - Positive control substance(s):
- yes
- Remarks:
- alpha-hexylcinnamicaldehyde
Results and discussion
- Positive control results:
- Following intradermal induction at 5% in distilled water, epidermal induction with neat test material and challenge with 50% solution all 10 animals responded with a skin reaction greater than control animals.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 1.0. Total no. in groups: 20.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 1.0. Total no. in groups: 20.0. Clinical observations: none.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Toluene was not a skin sensitizer in this study.
- Executive summary:
A guinea pig maximisation test in accordance with EU guideline B6 (Skin sensitisation) has been carried out. Twenty guinea pigs were intradermally injected with a 10% concentration and epidermally exposed to the undiluted test substance. Ten control guinea pigs were similarly treated, but with vehicle (corn oil) only. Two weeks later all animals were challenged with 50% (maximum non-irritant concentration) and 25% test solution, and vehicle. A single guinea pig showed a grade 1 reaction (discrete or patchy erythema) in response to the 50% solution. No other skin reactions were observed. It was concluded that toluene was not a skin sensitizer in this study. Toluene does not require classification for sensitisation properties.
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