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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report date:
1975

Materials and methods

Principles of method if other than guideline:
Buehler-Test with 20 animals which were induced by three 6 h applications within three weeks. Two weeks later the challenge application was done.
GLP compliance:
no
Type of study:
Buehler test

Test material

Constituent 1
Chemical structure
Reference substance name:
Decanoic acid
EC Number:
206-376-4
EC Name:
Decanoic acid
Cas Number:
334-48-5
Molecular formula:
C10H20O2
IUPAC Name:
decanoic acid

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
not specified

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: 40% ethanol for induction; acetone for challenge
Concentration / amount:
Induction: 5%
Challenge: 5%
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: 40% ethanol for induction; acetone for challenge
Concentration / amount:
Induction: 5%
Challenge: 5%
No. of animals per dose:
Test group: 20
Control group: 10
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: once a week for three weeks
- Exposure period: 6 hours
- Test groups: 20 animals
- Control group: 10 animals
- Concentrations: 5%


B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: two weeks after last induction
- Exposure period: 6 h
- Test groups: 20 animals
- Control group: 10 animals
- Concentrations: 5%
- Evaluation (hr after challenge): 24 and 48 hours after application

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
5%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
an occasional very slight degree of irritation was seen
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: an occasional very slight degree of irritation was seen.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
5%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
an occasional very slight degree of irritation was seen
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: an occasional very slight degree of irritation was seen.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
an occasional very slight degree of irritation was seen
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: an occasional very slight degree of irritation was seen.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
an occasional very slight degree of irritation was seen
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: an occasional very slight degree of irritation was seen.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information