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Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions. No positive control was used to demonstrate the validity and reliability of the method.
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
no positive control was used to demonstrate the validity and reliability of the method
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
The LLNA method was not available at the timepoint of test duration.
Species:
guinea pig
Strain:
other: Pirbright white
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Age at study initiation: 7 weeks
- Weight at study initiation: 340 g
- Housing: animals were housed in groups of 2-3 in Makrolon Type IV cages with standard softwood bedding.
- Diet: pelleted Altromin Maintenance Diet 3022 (Altromin GmbH, Lage, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-25
- Humidity (%): 45-70
- Air changes (per hr): 8
- Photoperiod (hrs dark / hrs light): 12/12
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
Induction: 50%
Challenge: 50%
Rechallenge: 25%
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
Induction: 50%
Challenge: 50%
Rechallenge: 25%
No. of animals per dose:
Range finding test: 3 (in test groups)
Main study: 10 (controls), 20 (in test groups)
Details on study design:
RANGE FINDING TESTS: 3 animals were exposed to 6, 12.5, 25 and 50% of the test substance in distilled water for 6 h. After treatment, treated areas were rinsed with tap water. The highest, technically possible concentration of 50% test substance in distilled water did not produce any skin reactions in the animals.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 h
- Test groups: test substance in distilled water
- Control group: distilled water
- Site: left flank
- Frequency of applications: every 7 days
- Duration: Day 0-21
- Concentrations: 50%

B. CHALLENGE EXPOSURE
- No. of exposures: 2 (challenge and rechallenge)
- Day(s) of challenge: 28 (challenge) and 35 (rechallenge)
- Exposure period: 6 h
- Test groups: test substance in distilled water
- Control group: test substance in distilled water
- Site: bilaterally (left and right cranial flank)
- Concentrations: 50% (challenge) and 25% (rechallenge)
- Evaluation (hr after challenge): 6 h
Challenge controls:
The control group is actually a challenge control.
Positive control substance(s):
no
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
induction: 0%; challenge: 50%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: induction: 0%; challenge: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
induction: 50%; challenge: 50%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: induction: 50%; challenge: 50%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
induction: 0%; challenge: 50%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: induction: 0%; challenge: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
induction: 50%; challenge: 50%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: induction: 50%; challenge: 50%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
rechallenge
Hours after challenge:
24
Group:
negative control
Dose level:
rechallenge: 25%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: negative control. Dose level: rechallenge: 25%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
rechallenge
Hours after challenge:
48
Group:
test chemical
Dose level:
rechallenge: 25%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: rechallenge: 25%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

There are limited data available on the skin sensitisation potential of D-Glucose, reaction products with alcohols C16-18 (even numbered) (excess). In order to fulfil the standard information requirements set out in Annex VII, 8.3, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006, read-across from structurally related substance is conducted.

A detailed justification for the grouping of chemicals and read-across is provided in the technical dossier (see IUCLID Sections 7.1 and 13).

One key study in guinea pigs on the skin sensitisation potential of D-Glucose, reaction products with alcohols C16-18 (even numbered) (excess) (30% C16/C18-APG and 70% C16/C18 fatty alcohols) according to the Buehler method (OECD guideline 406) is available (Henkel, 1993). In this GLP-study, 20 females were exposed to the test substance at a concentration of 50% in water during the induction phase. A control group was treated with the vehicle only. No skin sensitising effects were observed in any treated or control animals after treatment with the test substance at concentrations of 50% at challenge and 25% at rechallenge, respectively. Under the conditions of this study, the test substance was not considered to be a skin sensitiser.

Further studies are available for hexadecan-1-ol (CAS 36653-82-4), octadecan-1-ol (CAS 112-92-5), D-Glucopyranose, oligomeric, C10-16-alkyl glycosides, and D-Glucopyranose, oligomers, decyl octyl glycosides (CAS 68515-73-1), which support a non-sensitising potential of the substance to be registered.

The alcohols hexadecan-1-ol and octadecan-1-ol were tested under similar conditions in a GPMT according to OECD 406 and in compliance with GLP (SafePharm, 1996 a and b). In these experiments, guinea pigs were intradermally and epicutaneously induced with 1% and 50%, respectively, of the test substances in arachis oil and challenged with 25% or 50% of the test substance in arachis oil on respective flanks. No effects on skin were observed after treatment in any of the animals tested. Based on these results, hexadecan-1-ol and octadecan-1-ol were not sensitising to skin.

A GPMT with the category member D-Glucopyranose, oligomeric, C10-16-alkyl glycosides according to OECD 406 is available (Henkel, 1988). The animals were induced intradermally and epicutaneously with 0.1% and 10%, respectively, of the test substance in propylene glycol. At the 24 and 48 h examination, slight irritation was provoked by the challenge treatment with the test substance at 1.25% in 1/20 of the animals of the control groups, but not in the treated groups. At 2.5% challenge concentration, slight erythema were apparent in 3/20 animals of controls and 1/20 of the test group animals at the 24 h reading. At the 48 h examination, slight erythema were observed in 1/20 animals of the control and treated group, respectively. Based on these results, D-Glucopyranose, oligomeric, C10-16-alkyl glycosides had no sensitising effect on guinea pigs under the chosen experimental conditions.

No effects on skin sensitisation were also reported in a LLNA assay with the category member Decyl octyl glycosides at concentrations of 1, 3 and 10%, respectively (Zeneca, 1993). However, documentation of that study was too limited for assessment.

Migrated from Short description of key information:
Skin sensitisation (OECD 406): not sensitising

Justification for selection of skin sensitisation endpoint:
There is only one study available.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:
Justification for selection of respiratory sensitisation endpoint:
Study not required according to Annex VII-X of Regulation (EC) No 1907/2006.

Justification for classification or non-classification

The available data on skin sensitisation of D-Glucose, reaction products with alcohols C16-18 (even numbered) (excess) and for structurally related substances according to Regulation (EC) No 1907/2006, Annex XI, 1.5 do not meet the criteria for classification according to Regulation (EC) No 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.