Registration Dossier

Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
08 August 1980 to 06 September 1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
Acclimation perios is 4 days instead of 5 days.Pre and post study body weight not mentioned in the report.
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
At the time the study was performed the LLNA was not yet established.

Test material

Constituent 1
Chemical structure
Reference substance name:
Propan-2-ol
EC Number:
200-661-7
EC Name:
Propan-2-ol
Cas Number:
67-63-0
Molecular formula:
C3H8O
IUPAC Name:
propan-2-ol
Test material form:
liquid

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Murphy Breeding Laboratories
- Age at study initiation: Not specified
- Weight at study initiation: Not specified
- Housing: housed singly in wire mesh cages
- Diet: Purina Laboratory Guinea Pig chow , ad libitum
- Water: animals were maintained on medicated water containing 4% of sulfaethoxypyridazine for four days and after that they were furnished with non-medicated water, ad libitum
- Acclimation period: atleast 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not specified
- Humidity (%): Not specified
- Air changes (per hr): Not specified
- Photoperiod (hrs dark / hrs light): 12 / 12

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
100 % / 0.4 mL
Day(s)/duration:
6 hours weekly, 3 inductions
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
100 %
Day(s)/duration:
two weeks after second induction / 6 hours
No. of animals per dose:
test group: 20
control group: 10
Details on study design:
RANGE FINDING TESTS:
- Four animals were exposed for 6 hours period to various concentrations of the test substance
- Concentration: 100%, 50%, 25%, 10% v/v solution in distilled water
- Exposure period: 24 hours
- Grading: the patch site were scored for irritation four to five hours after washing

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3 induction exposure
- Exposure period: 6 hours
- Test groups: 0.4 mL of undiluted test substance
- Control group: none
- Site: upper left quadrant of the backs of the test animals
- Frequency of applications: once a week for 3 weeks
- Duration: 6 hours webril patches under occlusion
- Concentrations: 0.4 mL of undiluted test substance

B. CHALLENGE EXPOSURE
- No. of exposures: one 6 hour exposure
- Day(s) of challenge: two weeks after second induction
- Exposure period: 6 hours under occlusion
- Test groups: 0.4 mL of undiluted test substance
- Control group: 0.4 mL of undiluted test substance
- Site: lower left quedrant of the back of the test animals
- Concentrations: 0.4 mL of undiluted test substance
- Evaluation (hr after challenge): 24 and 48 hours after challenge exposure
Challenge controls:
10 animals treated with 100% Isopropyl alcohol
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no animals with positive responses
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no animals with positive responses
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no animals with positive responses
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no animals with positive responses
Key result
Group:
positive control
Remarks on result:
not measured/tested

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item was determined not to be skin sensitising.
Executive summary:

To investigate the skin sensitisating potential of the test item a Buehler test was performed. The test was performed with 20 guinea pigs in the test group and 10 guinea pigs in the control group. Animals of the test group were treated with undiluted test item for a period of 6 hours weekly for 3 induction exposures. The test animals and control animals were challenged with undiluted Isopropyl alcohol. No skin reactions were observed in the test and control animals therefore, it was concluded that the test item is not a skin senstiser.