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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: 79/831/EWG Annex V
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Chemical structure
Reference substance name:
2-octyldodecan-1-ol
EC Number:
226-242-9
EC Name:
2-octyldodecan-1-ol
Cas Number:
5333-42-6
Molecular formula:
C20H42O
IUPAC Name:
2-octyldodecan-1-ol
Details on test material:
- Name of test material (as cited in study report): 2-Octyldodecanol
- Physical state: liquid
- Analytical purity: no data
- Lot/batch No.:

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Pirbright White
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Winkelmann, Borchen (D)
- Weight at study initiation: 324 g
- Housing: Makrolon cage type IV
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum



ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 50-60
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
unchanged (no vehicle)
Concentration / amount:
intradermal induction: 0.2% test substance plus Freund's adjuvants
epicutaneous induction: 5%
challenge: 0.5 and 0.75% test substance
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
intradermal induction: 0.2% test substance plus Freund's adjuvants
epicutaneous induction: 5%
challenge: 0.5 and 0.75% test substance
No. of animals per dose:
20 per dose/control
Details on study design:
according to 79/831/EWG Annex V
Challenge controls:
Yes
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.5%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.5%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.5%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.5%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.75%
No. with + reactions:
1
Total no. in group:
20
Clinical observations:
grade 1 erythema
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.75%. No with. + reactions: 1.0. Total no. in groups: 20.0. Clinical observations: grade 1 erythema.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.75%
No. with + reactions:
1
Total no. in group:
20
Clinical observations:
grade 1 erythema
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.75%. No with. + reactions: 1.0. Total no. in groups: 20.0. Clinical observations: grade 1 erythema.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Under the conditions of the Magnusson Kligman test design, 2-Octyldodecan-1-ol was not sensitizing to the skin.
Executive summary:

Under the conditions of the Magnusson Kligman test design the test substance was not sensitizing to the skin.