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Diss Factsheets

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:
weight of evidence
Study period:
27 Nov - 21 Dec 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The DPRA assay resulted in a positive outcome whereas the h-CLAT assay gave a negative result. Taking into account the discrepancy in the results of the in vitro tests and the fact that the chemistry of the registration substance is complex an in vivo test was conducted. The GMPT was preferred over the LLNA due to the likelihood of the latter mentioned test producing false positive results with this type of substance - glyceryl undecylenate.

Test material

Constituent 1
Details on test material:
- Name of test material: undecylenate de glycerol
- Physical state: Pale yellow gel
- Analytical purity: 100%
- Lot/batch No.: 18060502

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories France
- Weight at study initiation: 338.2 - 391.5 g
- Housing: in cages of standard with saw dust bedding
- Diet: FD1 (P) SQC, SDS/DIETEX and V2233-000, SSNIFF feed, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 45-65
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal and epicutaneous
Vehicle:
corn oil
Concentration / amount:
Induction:
Intradermal: 1 %
Epicutaneous: 100%

Challenge: 50%
Challenge
Route:
epicutaneous, occlusive
Vehicle:
corn oil
Concentration / amount:
Induction:
Intradermal: 1 %
Epicutaneous: 100%

Challenge: 50%
No. of animals per dose:
Control groups: 5 males
Treated group: 10 males
Details on study design:
RANGE FINDING TESTS:
In the preliminary study, the concentrations of 0.5%, 1%, 5%, 10%, 25% and 50% were tested for the intradermal injection and the concentrations of 25%, 50% 75% and 100% were tested for the topical application.24 hours after intradermal injection of Glyceryl undecylenate, skin lesions were graded as score 2 (moderate and confluent erythema) at the concentrations of 0.5% and 1% and as score 3 (intense erythema and swelling) at the concentrations of 5% to 50%. One hour after the removal of the occlusive dressing of a topical application of Glyceryl undecylenate for 48 hours, skin lesions were graded as score 1 (discrete or patchy erythema) at the concentrations of 75% and 100%. 24 hours after the removal of the occlusive of a topical application of Glyceryl undecylenate for 24 hours, no visible skin changes were observed at the concentrations of 25% and 50% and skin lesions were graded as score 1 (discrete or patchy erythema) at the concentrations of 75% and 100%. 48 hours after the removal of dressing, no visible skin changes were observed, whatever the concentration tested.

According these results, the concentrations of Glyceryl undecylenate chosen for the main study were:
• 1% for the primary induction (intradermal injection on D1)
• 100% for the second induction (topical application on D9)
• 50% for the challenge (topical application on D22)

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous, respectively)
- Exposure period: single injection (intradermal) and 48 h (epicutaneous)
- Test groups:
Intradermal (3 pairs of injections):
Injection 1: FCA and sterile and pyrogen-free isotonic sodium chloride solution
Injection 2: test substance in corn oil
Injection 3: test substance in a 1:1 mixture (v/v) FCA
Epicutaneous: test substance in corn oil in a 1:1 mixture (w/v) FCA and sterile and pyrogen-free isotonic sodium chloride solution

- Control group:
Injection 1: FCA and sterile and pyrogen-free isotonic sodium chloride solution
Injection 2: corn oil
Injection 3: corn oil in a 1:1 mixture (w/v) FCA and sterile and pyrogen-free isotonic sodium chloride solution
Epicutaneous: vaseline

- Site: shoulder region (intradermal + epicutanous)
- Frequency of applications: every 9 days
- Duration: Days 0-9
- Concentrations: intradermal 1%, epicutaneous 100%

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 22
- Exposure period: 24 h
- Test groups: test substance and vehicle only
- Control group: test substance and vehicle only
- Site: cranial (vehicle) and caudal (test substance)
- Concentrations: 50%
- Evaluation (hr after challenge): 48 and 72

Positive control substance(s):
yes
Remarks:
Hexyl cinnamic aldehyde

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
induction: 0%; challenge: 50%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no abnormal clinical signs were noted
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
induction: 1%; challenge: 50%
No. with + reactions:
9
Total no. in group:
10
Clinical observations:
no abnormal clinical signs were noted
Remarks on result:
positive indication of skin sensitisation
Remarks:
In animals treated with Glyceryl undecylenate, 2/10 animals showed a slight erythema (score 1) and 7/10 animals showed a moderate erythema (score 2) on D24 (i.e. 24 hours after removal of occlusive dressing).
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
induction: 0%; challenge: 50%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no abnormal clinical signs were noted
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
induction: 1%; challenge: 50%
No. with + reactions:
4
Total no. in group:
10
Clinical observations:
no abnormal clinical signs were noted
Remarks on result:
positive indication of skin sensitisation
Remarks:
On D25 (i.e. 48 hours after removal of occlusive dressing), 4/10 animals showed a slight erythema (score 1).
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
no indication
No. with + reactions:
5
Total no. in group:
8
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
no indication
No. with + reactions:
5
Total no. in group:
5
Remarks on result:
positive indication of skin sensitisation

Any other information on results incl. tables

There was no mortality during the course of the study.

There were no abnormal clinical signs in animals treated with the test item, the negative control substance or the positive control substance, during the study. There was no change in body weight gain between predose and D25, whatever the group.

Applicant's summary and conclusion

Interpretation of results:
Category 1A (indication of significant skin sensitising potential) based on GHS criteria
Conclusions:
CLP: skin sensitiser - Sub-category 1A.