Registration Dossier
Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 208-749-7 | CAS number: 540-54-5
Toxicological information
Skin sensitisation
Currently viewing:
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
- Justification for type of information:
- Please refer to the read-across justification document attached to section 13 in IUCLID.
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
- Justification for non-LLNA method:
- Test was done before LLNA as first-choice method for in-vivo testing was set into force.
Test material
- Reference substance name:
- 2-chloropropane
- EC Number:
- 200-858-8
- EC Name:
- 2-chloropropane
- Cas Number:
- 75-29-6
- Molecular formula:
- C3H7Cl
- IUPAC Name:
- 2-chloropropane
- Test material form:
- liquid
Constituent 1
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, Animal Virus Research Institut, Pirbright Woking Surrey
- Weight at study initiation: 229 - 340 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 Spezialdiaten 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 75% , which produced only 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 (75%) 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 (75%) in Oleum arachidis
- Control group: 0.5 mL of Oleum arachidis (undiluted)
- Site: Left clipped flank (Test group); Right clipped flank (control group)
- Concentrations: 75% 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:
- 75%
- 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: 75%. 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:
- 75%
- 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: 75%. 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:
- GHS criteria not met
- Conclusions:
- CLP: not classified
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
