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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:
supporting study
Study period:
1986
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Contact sensitization assays in guinea pigs: are they predictive of the potential for systemic allergic reactions?
Author:
Vial T. & Descotes J.
Year:
1994
Bibliographic source:
Toxicology 93: 63-75
Reference Type:
publication
Title:
Development and Validation of an Alternative Dermal Sensitization Test: The Mouse Ear Swelling Test (MEST)
Author:
Gad S. C. et al.
Year:
1986
Bibliographic source:
Toxicol. Appl. Pharmacol 84, 93-114

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
no pre-treatment with SDS before topical induction, time of evaluation after challenge not given
GLP compliance:
no
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Study pre-dates validation of LLNA protocol.

Test material

Constituent 1
Reference substance name:
Propan-1-ol
EC Number:
200-746-9
EC Name:
Propan-1-ol
Cas Number:
71-23-8
IUPAC Name:
propan-1-ol

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- No data presented

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Concentration / amount:
100%
Day(s)/duration:
7 days
Route:
epicutaneous, occlusive
Concentration / amount:
100%
Day(s)/duration:
7 days
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
no data
Concentration / amount:
100%
Day(s)/duration:
7 days
No. of animals per dose:
Test group: 15
Control group: 6
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
Intradermal induction:
- No. of exposures: 2
- Test groups: test substance in vehicle, Freund's complete adjuvant (FCA), test substance in FCA
- Control group: Vehicle undiluted, FCA, vehicle in FCA (unclear which vehicle was used)
- Site: No data
- Frequency of applications: No data
- Concentrations: 100%

Topical induction (occlusive):
- Days after intradermal induction: 7
- No. of exposures: 1
- Test groups: Substance in vehicle applied to intradermal injection skin site
- Control group: Undiluted vehicle applied to intradermal injection skin site
- Duration: 48 hours
- Concentrations: 100%

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 21 days after induction
- Exposure period: 24 hours
- Test groups: Substance in vehicle applied to naive skin
- Control group: Undiluted vehicle applied to naive skin
- Concentrations: 100 %
- Evaluation (hr after challenge): No data

OTHER:
If necessary a rechallenge was planned 7 day after challenge.
Positive control substance(s):
yes
Remarks:
Dinitrochlorobenzene (intradermal induction: 0.1 %; topical induction: 0.1 %; challenge: 0.1 %). Vehicle: propylene glycol

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:
15
Clinical observations:
No data
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 15.0. Clinical observations: No data.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
100 %
No. with + reactions:
0
Total no. in group:
6
Clinical observations:
No data
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 6.0. Clinical observations: No data.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
0.1 % in propylene glycol
No. with + reactions:
15
Total no. in group:
15
Clinical observations:
No data
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 0.1 % in propylene glycol. No with. + reactions: 15.0. Total no. in groups: 15.0. Clinical observations: No data.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In a guinea pig maximisation test, propanol was tested negative for skin sensitisation.
Executive summary:

In a dermal sensitisation study (equivalent to OECD 406) with propanol, 15 guinea-pigs of the Hartley strain were tested using the method of Magnusson and Kligman. No dermal reactions were seen after challenging the test animals for 24 hours. In this study, propanol is not a dermal sensitiser.