Propanoic acid, 2-hydroxy-, propyl ester, (2S)-

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

publication

Title:

Development and validation of an alternative dermal sensitization test: the mouse ear swelling test (MEST)

Author:

Gad S.C., Dunn B.J., Dobbs D.W., Reilly C. and Walsh R.D.

Year:

1986

Bibliographic source:

Toxicology and applied pharmacology 84, 93-114

Materials and methods

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

No guideline was available at the time the study was performed; the study was part of the development and validation of the mouse ear swelling test (MEST).

- Short description of test conditions:
CF-1 female mice, 6 to 8 weeks old, were shaved and tape stripped at the start of each study. As a standard part of this design, two id injections totalling 0.05 mL of FCA were performed into the stomach induction site of unanaesthetised mice prior to the first induction application. All mice were then topically dosed with 100 µL of test material in solvent or solvent alone (for controls) applied to the center of the shaved region. s returned to its cage. The application was allowed to dry before the animal was returned to its cage.
Tape stripping and topical application of the appropriate solution to the stomach were repeated for three additional consecutive days. Seven days after the final topical application to the stomach, 20 µL of test compound in solution was applied to the left ear of each animal (test and control), and 20 µL of the solvent was applied to the right ear. At both 24 and 48 hr after this challenge, animals were lightly anesthetized with ether and the thicknesses of both ears measured. As an additional guard against false positives, should it be felt necessary, ear thicknesses may also be measured the day before challenge to protect against the small random chance of a naturally occurring “difference” in test or control groups.

GLP compliance:

no

Type of study:

mouse ear swelling test

Justification for non-LLNA method:

Study pre-dates validation of LLNA protocol.

Test material

Test material information

1

Reference substance name:

Propan-1-ol

EC Number:

200-746-9

EC Name:

Propan-1-ol

Cas Number:

71-23-8

Molecular formula:

C3H8O

IUPAC Name:

1-propanol

In vivo test system

Test animals

Species:

mouse

Strain:

CF-1

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: CF-1 female mice from Charles River Breeding Laboratories
- Age at study initiation: 6 to 8 weeks old,
- Weight at study initiation:
- Housing: five per cage in wire-bottom stainless-steel cages
- Diet: ad libitum, Purina Rodent Laboratory Chow 5001
- Water: ad libitum
- Acclimation period: 5 days
- Indication of any skin lesions: animals were screened to remove any from testing that have ears that appear red or swollen (due to infection or mishap).

ENVIRONMENTAL CONDITIONS
- not reported

Study design: in vivo (non-LLNA)

No. of animals per dose:

10-15

Details on study design:

CF-1 female mice, 6 to 8 weeks old, were shaved and tape stripped at the start of each study. As a standard part of this design, two id injections totaling 0.05 mL of FCA were performed into the stomach induction site of unanesthetized mice prior to the first induction application. A 1-cc tuberculin syringe with a 30-gauge needle was used in each of 10 or 15 test mice and 5 or 10 control mice (the larger number being used when there was concern about systemic toxicity a&r the probe study). All mice were then topically dosed with 100 µL of test material in solvent or solvent alone (for controls) applied to the center of the shaved region. The application was allowed to dry before the animal was returned to its cage. Tape stripping and topical application of the appropriate solution to the stomach were repeated for three additional consecutive days. Seven days after the final topical application to the stomach, 20 µL of test compound was applied to the left ear of each animal (test and control), and 20 µL of the solvent was applied to the right ear. At both 24 and 48 hr after this challenge, animals were lightly anesthetized with ether and the thicknesses of both ears measured. As an additional guard against false positives, should it be felt necessary, ear thicknesses may also be measured the day before challenge to protect against the small random chance of a naturally occurring “difference” in test or control groups.

Results and discussion

In vivo (non-LLNA)

Results

Results 1

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

100%

Total no. in group:

10

Remarks on result:

no indication of skin sensitisation

Remarks:

101% ear swelling compared to control

Results 2

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

100%

Total no. in group:

10

Remarks on result:

no indication of skin sensitisation

Remarks:

101 % Ear Swelling compared to control

Any other information on results incl. tables

MEST results for propanol: 0% sensitized and 101% swelling. The substance is no skin sensitizer. The publication lists no sensitisation of propanol in GMPT, Closed patch type tests and Human results.

Applicant's summary and conclusion

Interpretation of results:

other: CLP criteria not met

Conclusions:

The test substance propanol (100%) was found as not sensitising in the non-guideline study (Mouse Ear Swelling Test (MEST)) conducted on CF-1 mice.

Executive summary:

Propanol (100%) was tested in non-guideline in vivo sensitization study (Mouse Ear Swelling Test ) conducted on CF-1 female mice. Prior to topical induction with 100 µL test material, 10 -15 female CF-1 mice were shaved, and tape stripped and intradermally injected twice with 0.05 mL FCA into the stomach induction site.

Tape stripping and topical application of the appropriate solution to the stomach were repeated for three additional consecutive days. Seven days after the final topical application to the stomach, 20 µL of test compound was applied to the left ear of each animal (test and control), and 20 µL of the solvent was applied to the right ear. Measurements of ear thickness were performed at both 24 and 48 hours after challenge. MEST results for propanol indicated no sensitisation in mice (0% sensitized) and ear swelling comparable to controls (101% swelling). Based on the results of this study, the test substance propanol (100%) was not a skin sensitizer.