Registration Dossier
Registration Dossier
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EC number: 402-030-3 | CAS number: 624-86-2
Toxicological information
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guidelines with acceptable restrictions (no concurrent nor historical positive controls, no data on substance purity)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- (no concurrent nor historical positive controls, no data on substance purity)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- A well-conducted and fully reported sens study conducted in 1987 is available that can be used for the purposes of classification and labelling as well as risk assessment. Conducting further testing is not considered adequate.
Test material
- Reference substance name:
- O-ethylhydroxylamine
- EC Number:
- 402-030-3
- EC Name:
- O-ethylhydroxylamine
- Cas Number:
- 624-86-2
- Molecular formula:
- C2 H7 N O
- IUPAC Name:
- O-ethylhydroxylamine
- Details on test material:
- - CTL reference number: Y05460/002/001
- Name of test substance as cited in report: Substance H109360
- Identification of test sample as cited in report: 50% (w/v) aqueous solution (45% Substance H109360 and approximately 5% ethanol)
- Appearance: clear aqueous solution
- Lot #: EFI-100
- Analytical purity: not specified
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: The Animal Breeding Unit, Imperial Chemical Industries PLC, Pharmaceuticals Division, Alderley Park, Macclesfield, Cheshire, UK.
- Weight at study initiation: 317-375 g
- Housing: individually in suspended cages (37cm length x 32cm width x 20cm height)
- Age at study initiation: not specified
- Diet: ad libitum: Labsure RGP Guinea Pig diet
- Water: ad libitum, via automatic system
- Acclimation period: minimum of 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-22
- Humidity (%): 40-50
- Air changes (per hr): 20-30
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- - Intradermal induction: 3%
- Epicutaneous induction: 10%
- Challenge: undiluted and 30%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- - Intradermal induction: 3%
- Epicutaneous induction: 10%
- Challenge: undiluted and 30%
- No. of animals per dose:
- - Control: 10
- Test groups: 20 - Details on study design:
- JUSTIFICATION FOR CHOICE OF CONCENTRATIONS
- Based on results of range finding test
RANGE FINDING TESTS (RFT): Intradermal injection
- No. of animals: at least 2 animals/dose
- Concentrations: upto 10% (up to 4 doses)
- Vehicle: Water
RANGE FINDING TESTS (RFT): Epicutanous application
- No. of animals: at least 2 animals/dose
- Vehicle: water
MAIN STUDY
A INDUCTION EXPOSURE
Intradermal injection
- Site: scapular region (5 x 5 cm)
- Test substance group: (Top): Freund's complete adjuvant (FCA) plus water 1:1
- Test substance group: (Middle): The test article in vehicle
- Test substance group: (bottom): Freund's complete adjuvant and test article in vehicle (1:1)
- Control group (Top): Freund's complete adjuvant (FCA) plus vehicle 1:1
- Control group (middle): Vehicle
- Control group (bottom): Freund's complete adjuvant plus vehicle (1:1)
- Concentrations: 3%
- Volume per injection: 0.05-0.1 ml
Epicutaneous induction exposure
- Time schedule: 7 days after intradermal injection
- Site: same as intradermal injection
- Method of test substance application: on 2 x 4 cm filter paper
- Type of coverage: occlusive (adhesive elastic bandage (approximate size 20-30cm x 5cm))
- Concentrations: 10%
- vehicle: water
- Volume applied: 0.2-3.0 ml applied on filter paper
- Duration: 48 hours
B. CHALLENGE EXPOSURE (test group and control animals treated alike)
- Time schedule: 14 days after termination of induction exposure
- Site: left flank (test substance; undulited) right flank (30% in vehicle)
- Area of application: 1 x 1-2 cm
- Concentrations: undiluted test sample and 30% in vehicle
- Vehicle: water
- Volume applied: 0.5 ml/animal
- Type of coverage: Occlussive coverage with a strip of adhesive bandage (approximate size 25-40cm x 1 .5cm) and secured with self-adhesive PVC tape
- Duration: 24 hours
- Evaluation (hr after challenge): 24 and 48 hours after termination of exposure
SCORINGS SYSTEM:
- 0: no reaction
- 1: scattered mild redness
- 2: moderate diffuse redness
- 3: intense redness and swelling - Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- undiluted
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- not reported
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: undiluted . No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: not reported.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- undiluted
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- not reported
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: undiluted. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: not reported.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 30%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- not reported
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 30%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: not reported.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 30%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- not reported
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 30%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: not reported.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- undiluted
- No. with + reactions:
- 3
- Total no. in group:
- 19
- Clinical observations:
- not reported
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: undiluted. No with. + reactions: 3.0. Total no. in groups: 19.0. Clinical observations: not reported.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- undiluted
- No. with + reactions:
- 2
- Total no. in group:
- 19
- Clinical observations:
- not reported
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: undiluted. No with. + reactions: 2.0. Total no. in groups: 19.0. Clinical observations: not reported.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 30%
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Clinical observations:
- not reported
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 30%. No with. + reactions: 0.0. Total no. in groups: 19.0. Clinical observations: not reported.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 30%
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Clinical observations:
- not reported
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 30%. No with. + reactions: 0.0. Total no. in groups: 19.0. Clinical observations: not reported.
Any other information on results incl. tables
One test animal was not included in the final assessment as the bandage had slipped during the challenge application (no erythema was seen on this animal.
3/19 animals of the test substance group (approx.16%) was regarded as sensitized. This is below the threshold of 30% required for classification according to the 67/548/EEC Annex VI.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
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