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Description of key information

The skin sensitisation of isopropyl alcohol has been tested in guinea pigs. In a study conducted according to OECD Test Guideline 406, Buehler method, and in compliance with GLP, it was that isopropyl alcohol is not sensitizing via skin.

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:
1980-08-08 to 1980-09-06
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: According to OECD Guideline 406 (Skin Sensitisation)
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
Acclimation period is 4 days instead of 5 days.Pre and post study body weight not mentioned in the report
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
The study was carried out prior to the introduction of the LLNA method.
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 available
- Weight at study initiation: Not available
- Housing: housed singly in wire mesh cages
- Diet (e.g. ad libitum): Purina Laboratory Guinea Pig chow , ad libitum
- Water (e.g. ad libitum): 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 available
- Humidity (%): Not available
- Air changes (per hr): Not available
- Photoperiod (hrs dark / hrs light): 12 hour light /12 hour dark cycle


IN-LIFE DATES: From: 1980-08-08 To: 1980-09-06
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
One group of 20 test animals was treated with 0.4ml of 100% Isopropyl alcohol for a period of 6 hours weekly for 3 induction exposure.
Test group and 10 control animals were challenged with 100% Isopropyl alcohol.
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
One group of 20 test animals was treated with 0.4ml of 100% Isopropyl alcohol for a period of 6 hours weekly for 3 induction exposure.
Test group and 10 control animals were challenged with 100% Isopropyl alcohol.
No. of animals per dose:
20 animals in the test substance group and 10 animals in the vehicle control were treated with 100% Isopropyl alcohol
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 later 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

OTHER: None
Challenge controls:
10 animals treated with 100% Isopropyl alcohol
Positive control substance(s):
no
Positive control results:
There are no positive control data for this study
Reading:
1st reading
Group:
positive control
Remarks on result:
not measured/tested
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
100% Isopropyl alcohol
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no animals with positive responses
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100% Isopropyl alcohol. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no animals with positive responses.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
100% Isopropyl alcohol
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no animals with positive responses
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 100% Isopropyl alcohol. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no animals with positive responses.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
100% Isopropyl alcohol
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no animals with positive responses
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100% Isopropyl alcohol. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no animals with positive responses.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
100% Isopropyl alcohol
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no animals with positive responses
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 100% Isopropyl alcohol. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no animals with positive responses.
Interpretation of results:
GHS criteria not met
Conclusions:
Isopropyl alcohol did not induce sensitization in the guinea pig model.
Executive summary:

One group of 20 test animals was treated with undiluted Isopropyl alcohol 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 Isopropyl alcohol is not a sensitizer.

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

The skin sensitisation potential of propan-2-ol was assessed in a study performed according to OECD Test Guideline 406 and in compliance with GLP in male and female Hartley guinea pigs (Hill Top Research, Inc, 1980). In the study, 10 animals/sex comprised the propan-2-ol test group and 5 animals/sex comprised the control group.  The epicutaneous induction was carried out with 0.4 mL of undiluted propan-2-ol (100% w/w) at the upper left quadrant of the back of the test group animals (3 induction exposures during 3 weeks, each exposure for 6 hours with Webril patches under occlusion).  The challenge exposure also was conducted with 0.4 mL of undiluted propan-2-ol at the lower left quadrant of the back of the test group and control group animals. Skin reactions were observed and recorded 1 hour after dermal induction and 24 and 48 hours after the challenge exposure. No positive skin reactions were observed in all animals 24 or 48 hours after challenge. Under the experimental conditions and according to the epicutaneous method of Buehler, no cutaneous reactions attributable to the sensitisation potential of propan-2-ol were observed in guinea-pigs.  Therefore, the results of this study demonstrated that propan-2-ol showed no evidence of contact skin sensitisation in guinea pigs.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The substance does not meet the criteria for classification and labelling for skin sensitisation according to Regulation (EC) No. 1272/2008.