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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
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:
other: 79/831/EWG Annex V
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Study was conducted before the REACH Regulation came into force.

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 group
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.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
0.5%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
test group
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.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
0.75%
No. with + reactions:
1
Total no. in group:
20
Clinical observations:
grade 1 erythema
Remarks on result:
no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
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.