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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Administrative data

Description of key information

The registered substance does not induce any signs of skin sensitization in animals when evaluated in the guinea pig maximization test according to OECD TG 406. The sensitization incidence was 0%.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Remarks:
Study was conducted prior availability of validated in vitro systems
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study according to GLP
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The test material has surfactant properties. According to OECD TG 429, false positive findings may be expected in the LLNA with surfactant type chemicals. Subject to this limitation, the use of the OECD TG 406 is adviced.
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River France
- Age at study initiation: approximately 4 weeks
- Housing: group housing, Noryl cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 24° C
- Humidity (%): 40 - 70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hour cycle

Route:
intradermal and epicutaneous
Vehicle:
propylene glycol
Concentration / amount:
Based on a preliminary irritation screening the following test concentrations were selected:
20% (w/v) for intradermal induction
2 % (w/v) for topical induction
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Route:
epicutaneous, occlusive
Vehicle:
propylene glycol
Concentration / amount:
Based on a preliminary irritation screening the following test concentrations were selected: 2 % (w/v) for topical challenge
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
5 control animals
10 test animals
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
2%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 2%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: none.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
2%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 2%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
2%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 2%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
2%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 2%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the above mentioned findings in an adjuvant sensitization test (M&K-test) in guinea pigs and in accordance to Commission Directive 2001/59/EC, C18/C18 unsatd.-Glucamide does not have to be classified and labelled as a skin sensitizer (sensitization incidence = 0%).
Executive summary:

The sensitization potential of C18/18 unsatd.-Glucamide was evaluated in guinea-pig according to the Maximization Test by Magnusson and Kligman. The intradermal induction of sensitization in the test group was performed in the nuchal region with a 20 % dilution of the test item in propylene glycol and in an emulsion of Freund's Complete Adjuvant (FCA)/physiological saline. The epidermal induction of sensitization was conducted for 48 hours under occlusion with the test item at 2 % one week after the intradermal induction. Two weeks after epidermal induction the control and test animals were challenged by epidermal application of the test item at 2% in propylene glycol under occlusive dressing. Cutaneous reactions were evaluated at 24 and 48 hours after removal of the dressing.

No toxic signs were evident in the guinea pigs of the control or test group. No deaths occurred. No skin reactions were observed in the control and test group after the challenge treatment with the test item after the challengte treatment. Based on the results of this study, C18/C18 unsatd.-Glucamide is not considered to be a skin sensitizer (sensitization incidence = 0%).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Glucamide OL is not a skin sensitizer based on the results from a GPMT according to OECD TG 406. Also no sensitizing potential was revealed for structural and biological close analogues. None of the available toxicological data and known exposure conditions indicates concern that Glucamide OL may possess respiratory sensitization properties. Based on all available data the registered substance is not a sensitiser and therefore is not subject for classification and labelling requirements with regard to this endpoint.