Propan-2-ol

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Meets generally accepted scientific standards, well documented and 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., Walsh R.D.

Year:

1986

Bibliographic source:

Toxicol. Appl. Pharmacol. 84, 93-114.

Materials and methods

Principles of method if other than guideline:

Not reported

GLP compliance:

no

Type of study:

mouse ear swelling test

Test material

Test material information

Constituent 1

Reference substance name:

Automatically generated during migration to IUCLID 6, no data available

IUPAC Name:

Automatically generated during migration to IUCLID 6, no data available

Details on test material:

propan-1-ol
Analytical purity: > 98 %.

In vivo test system

Test animals

Species:

mouse

Strain:

CF-1

Sex:

female

Details on test animals and environmental conditions:

- Age at study initiation: 6-8 weeks
- Housing: 5/cage
- Diet: ad libitum, (Purina Rodent Laboratory Chow 5001)
- Water: ad libitum
- Aclimation: 7 days (during this period, any animal with red or swollen ear disqualified and was removed from the study)

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

intradermal and epicutaneous

Vehicle:

unchanged (no vehicle)

Induction 2

Concentration / amount:

Induction: 100%
Challenge: 100%

Basis of selection: Based on solubility of n-propanol

Challenge

Challenge 1

Route:

epicutaneous, open

Vehicle:

unchanged (no vehicle)

Challenge 2

Concentration / amount:

Induction: 100%
Challenge: 100%

Basis of selection: Based on solubility of n-propanol

No. of animals per dose:

Test groups: 10
Irritation control: 5

Details on study design:

PRELIMINARY RANGE FINDING TEST

- Number of animals: 2/concentration
- Induction: procedure as described in main study whereby four concentrations were used for induction; no further information
- Challenge: each group was challenged at a different concentration; no further details given
- Evaluation: 24 h after challenge
Results: Concentrations utilized in the main study was the highest with minimal iiritation or non-iiritating to the stomach (for induction) and nonirritating to the ear (for challenge)

MAIN STUDY

IRRITATION CONTROL ANIMALS
INDUCTION EXPOSURE:
- Site of application: Abdomen
- Shaved: yes, before application on Day 0
- FCA (Freund's Complete Adjuvant) pretreatment: Yes, injected intradermally 2x á 0.05 ml after which the abdominal skin was then tape stripped.
- Volume: it is unclear from reporting if control animals were induced with a control substance or not, since test substance was applied undiluted (unchanged)
- Repeation: Yes, tape stripping and topical induction applications were repeated for additional 3 consecutive days

CHALLENGE
- Time schedule: 7 days after induction
- Area of application: left ear, (test substance); right ear (treatment unclear; untreated or if treated what solvent was employed)
- Volume applied: 20 µl
- Concentration: undiluted (100%)
- Evaluation: 24h and 48h after challenge
- Anesthesia: Yes, ether before measurement

TEST GROUP
INDUCTION EXPOSURE:
- Site of application: Abdomen
- Shaved: yes, before application on Day 0
- FCA (Freund's Complete Adjuvant) pretreatment: Yes, injected intradermally 2x á 0.05 ml after which the abdominal skin was then tape stripped.
- Volume (Test substance): 100µl applied topically to the center of the shaved region. Area dried with electric dryer
- Concentration: undiluted (100%)
- Repeation: Yes, tape stripping and topical induction applications were repeated for additional 3 consecutive days

CHALLENGE
- Time schedule: 7 days after induction
- Area of application: left ear, (test substance); right ear (treatment unclear; untreated or if treated what solvent was employed)
- Volume applied: 20 µl
- Concentration: undiluted (100%)
- Evaluation: 24h and 48h after challenge
- Anesthesia: Yes, ether before measurement

Positive control substance(s):

yes

Remarks:

Ethylene diamine, dinitrochlorobenzene and p-phenylenediamine

Results and discussion

In vivo (non-LLNA)

Results

Results 1

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

Induction 100%; challenge 100%

No. with + reactions:

0

Total no. in group:

10

Clinical observations:

no data

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: Induction 100%; challenge 100% . No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no data.

Results 2

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

Induction 100%; challenge 100%

No. with + reactions:

0

Total no. in group:

10

Clinical observations:

no data

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: Induction 100%; challenge 100% . No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no data.

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

not sensitising