Registration Dossier

Administrative data

Description of key information

skin sensitisation (OECD 406, RL1): not sensitising

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
Justification for type of information:
Please refer to the read-across justification document attached to section 13 in IUCLID.
Reference:
Composition 1
Qualifier:
according to
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 information:
Composition 1
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


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 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
Positive control results:
No data
Reading:
1st reading
Hours after challenge:
24
Group:
test group
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 group
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:
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:
Interpretation of results:
GHS criteria not met
Conclusions:
CLP: not classified
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Skin sensitization

CAS 75-29-6

A guinea pig maximization test was performed according to OECD 406 with 2-chloropropane (reference 7.4.1-1). Based on the results of a range-finding study, the following concentrations were used: For intradermal injections, 10% test substance dissolved in oleum arachidis were selected. For epidermal applications, 75% test substance (dissolved in oleum arachidis) was applied. 20 animals per dose and per control group were treated with 2-chloropropane for 48 h during induction (epicutaneous application) and for 24 h during challenge. No skin reactions were observed for animals in either group. Weight gain was unremarkable throughout the study for all animals. Thus, based on the results of the conducted study, 2-chloroprpane is not considered to exhibit skin sensitizing properties.

 

In conclusion, based on the available data and the analogue approach, 1-chloropropane is not considered as skin sensitizer, which is in agreement to the harmonized classification according to Annex VI of CLP.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the available data and the analogue approach, 1-chloropropane does not meet the classification criteria according to Regulation (EC) 1272/2008.