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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:
key study
Study period:
June to July 2019
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
Study was perfomed for the notification in other egions where authorities do not accept in vitro and/or read-across data.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2019
Report date:
2019

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
July 17, 1992
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Test was done based on an authority study request from another region.

Test material

Constituent 1
Reference substance name:
Guerbet alcohols, C24-26, branched and cyclic
EC Number:
942-520-9
Cas Number:
2041102-78-5
Molecular formula:
not applicable, UVCB
IUPAC Name:
Guerbet alcohols, C24-26, branched and cyclic
Test material form:
liquid

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Breeder: Charles River France Laboratories, Domaine des Oncins B.P. 0109, F 69592 L’ARBRESLE CEDEX, France
- Females (if applicable) nulliparous and non-pregnant: yes]
- Age at study initiation: 4 to 5 weeks
- Weight at study initiation: 270 to 290 g
- Housing: Noryl cages measuring 74.3×54.3×25 cm
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: At least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C±2°C
- Humidity (%): 55%±15%
- Air changes (per hr): Approximately 15 to 25 a
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
other: sesame oil
Concentration / amount:
50 %
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Adequacy of induction:
non-irritant substance, but skin pre-treated with 10% SDS
Challenge
Route:
epicutaneous, occlusive
Vehicle:
other: sesame oil
Concentration / amount:
50%
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
20 (test group)m 10 (control group)
Details on study design:
according to guideline
Challenge controls:
undiluted negative control (sesame oil)
Positive control substance(s):
yes
Remarks:
historical control (alpha-hexylcinnamaldehyde)

Results and discussion

Positive control results:
8/10 animals showed slight/well defined erythema 24 and 48 h after challenge.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
vehicle sesame oil
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
vehicle sesame oil
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
vehicle sesame oil
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
50%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
vehicle sesame oil
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
10 % in acetone
No. with + reactions:
8
Total no. in group:
10
Remarks on result:
positive indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
10 % in acetone
No. with + reactions:
8
Total no. in group:
10
Remarks on result:
positive indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
At the challenge with the test item, no response was apparent in any animal of the test or control group. These results indicate that the test item, Guerbet alcohols, C24-26, branched and cyclic, does not elicit a skin sensitisation response in the guinea pig.
Executive summary:

The potential of the test item, Guerbet alcohols, C24-26, branched and cyclic, to induce and elicit delayed dermal sensitisation was assessed by a guinea pig model using the maximisation test of Magnusson and Kligman.

The concentrations of the test item used in the main study were determined by the results of preliminary screening tests. The main sensitisation test was undertaken using a test group of 20 animals and a control group of 10 animals. In an attempt to induce sensitisation, test animals were intradermally injected with an emulsion of Freund’s complete adjuvant (anterior sites), the test item at 50% concentration (middle sites) in the vehicle and the test item at 50% concentration in an emulsion of Freund’s complete adjuvant (posterior sites).

One week later, animals were boosted by topical application of the undiluted test item over the injection sites. Control group animals were treated in the same manner but the selected vehicle (sesame oil) was used in place of the test item. Two weeks after the second induction stage, all animals were challenged by topical application of both the vehicle (sesame oil) and the test item at concentration of 50% in sesame oil.

At the challenge with the test item, no response was apparent in any animal of the test or control group. No reaction to the vehicle alone was observed in any animal.

These results indicate that the test item, Guerbet alcohols, C24-26, branched and cyclic, does not elicit a skin sensitisation response in the guinea pig.