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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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
Principles of method if other than guideline:
Not reported
GLP compliance:
no
Type of study:
mouse ear swelling test
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)
Route:
intradermal and epicutaneous
Vehicle:
unchanged (no vehicle)
Concentration / amount:
Induction: 100%
Challenge: 100%

Basis of selection: Based on solubility of n-propanol
Route:
epicutaneous, open
Vehicle:
unchanged (no vehicle)
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
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.
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.
Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
not sensitising
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:
Migrated from Short description of key information:
Propan-2-ol is not sensitising

Justification for classification or non-classification