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Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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
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
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


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
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
Positive control results:
No data
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.
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Sec-Butylchlorifde has been tested for skin sensitization potential in a Magnusson-Kligman test according to OECD406. No sensitising potential was observed. Thus the substance is considered not sensitizing to skin.


Migrated from Short description of key information:
The compound sec-butylchlorid is considered to cause no contact hypersensitivity in guinea-pigs.

Justification for selection of skin sensitisation endpoint:
Only one valid OECD guideline study available

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

2 -Chlorobutane has been investigated for skin sensitising potential in a Magnusson-Kligman test according to OECD406 and was found not to induce skin sensitisation. Consequently, the substance is not subject to classification according to CLP (Regulation (EC) No 1272/2008) nor according to DSD (Directive 67/548/EEC).

Respiratory sensitisation can not be assessed in an animal experiment and hence no test datat are available. No epidemiological findings regarding respiratory sensitisation were identified in publically available literature and therefore the substance is not classified for respiratory sensitisation due to lack of data.