Registration Dossier
Registration Dossier
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EC number: 201-151-7 | CAS number: 78-86-4
Toxicological information
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well documented, according to accepted guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- Year 1981
- Deviations:
- yes
- Remarks:
- results of reliability checks not reported in study report
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Sec-Butylchloride
- IUPAC Name:
- Sec-Butylchloride
- Reference substance name:
- 2-Chlor-butan
- IUPAC Name:
- 2-Chlor-butan
- Reference substance name:
- 2-chlorobutane
- EC Number:
- 201-151-7
- EC Name:
- 2-chlorobutane
- Cas Number:
- 78-86-4
- Molecular formula:
- C4H9Cl
- IUPAC Name:
- 2-chlorobutane
- Test material form:
- other: colourless, clear liquid
- Details on test material:
- - Name of test material (as cited in study report): Sec-butylchlorid, 2-Chlor-butan
- Physical state: liquid
- Lot/batch No.: Not reported
- Storage condition of test material: In the refrigerator at 5°C ± 2°C
Constituent 1
Constituent 2
Constituent 3
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright Bor: DHPW (SPF)
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Firma Winkelmann, Versuchstierzucht Gartenstrabe 30, D-4791 Borchen 1, GERMANY, Animal Virus Research Institut, Pirbright Woking Surrey
- Weight at study initiation: 226 - 352 g
- Housing: Maximum 5 animals per cage
- Diet (e.g. ad libitum): ad libitum, Ssniff-G (pellets, 1.0cm large, 0.5 cm diameter), Ssniff Spezialdiäten GmbH
- Water (e.g. ad libitum): ad libitum, aqua fontana as for human consumption
- Acclimation period: Not less than 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 2 °C
- Humidity (%): 50-85%
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: Oleum arachidis
- Concentration / amount:
- For intradermal injections the concentration of the test substance (TS) was 10% in the vehicle and 10% in Freund's Adjuvant complete (FCA)
For the Dermal treatments the test material was 75% in the vehicle
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Oleum arachidis
- Concentration / amount:
- For intradermal injections the concentration of the test substance (TS) was 10% in the vehicle and 10% in Freund's Adjuvant complete (FCA)
For the Dermal treatments the test material was 75% in the vehicle
- No. of animals per dose:
- 20 test animals and 20 control animals
- Details on study design:
- RANGE FINDING TESTS:
To exclude primary skin irritations two animals/group were treated once dermally in a preliminary study under occlusive conditions with the following concentrations (each 0.5 mL/animal) of the sample: 100% (undiluted), 75%, 50%, and 10% in Oleum arachidis; intradermal: 10% and 5% in Oleum arachidis.
The range finding study found slight erythema at 100% (undiluted) concentrations of the test substance, therefore, for the purposes of the sensitization study the concentration of 50% , which produced only very slight erthyema, was used.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal then epicutaneous)
- Exposure period: 48 hours (epicutaneous)
- Test groups: 1st induction (0.05 mL): TS (10%) + Oleum arachidis; TS (10%) + FCA; FCA (undiluted). 2nd induction (0.5 mL): TS (50%) in Oleum arachidis
- Control group: 1st induction (0.05 mL): FCA (undiluted); FCA + Oleum arachidis (10%); Oleum arachidis (undiluated); . 2nd induction (0.5 mL): Oleum arachidis (undiluted)
- Site: back (skin areas situated bilaterally to the spin)
- Duration: 3 weeks
- Concentrations: same as mentioned above throughout the study
B. CHALLENGE EXPOSURE
- No. of exposures: 1 (epicutaneous)
- Day(s) of challenge: 21
- Exposure period: 24 hours
- Test groups: 0.5 mL of TS (50%) in Oleum arachidis
- Control group: 0.5 mL of Oleum arachidis (undiluted)
- Site: Left clipped flank (Test group); Right clipped flank (control group)
- Concentrations: 50% TS
- Evaluation (hr after challenge): 24 and 48 h after removal of TS
- Challenge controls:
- The control group served to demonstrate that results observed were not attributable to the vehicle used.
- Positive control substance(s):
- not specified
Results and discussion
- Positive control results:
- No data
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None reported
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: None reported.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None reported
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: None reported.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: vehicle control
- Dose level:
- Vehicle only
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None reported
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: vehicle control. Dose level: Vehicle only. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: None reported.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: Vehicle control
- Dose level:
- vehicle only
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None reported
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: Vehicle control. Dose level: vehicle only. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: None reported.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The compound sec-butylchlorid is considered to cause no contact hypersensitivity in guinea-pigs.
- Executive summary:
The compound sec-butylchlorid is considered to cause no contact hypersensitivity in guinea-pigs.
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