D-Glucitol, 1-deoxy-1-(methylamino)-, N-C8-10 acyl derivs.

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

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

Test material

Test material information

Constituent 1

Reference substance name:

D-Glucitol, 1-deoxy-1-(methylamino)-, N-[C8-10(even numbered) acyl] derivs.

EC Number:

940-284-1

Cas Number:

1591782-62-5

Molecular formula:

C15H31NO6 C17H35NO6

IUPAC Name:

D-Glucitol, 1-deoxy-1-(methylamino)-, N-[C8-10(even numbered) acyl] derivs.

Test material form:

other: solid

Details on test material:

Chemical Name: D-Glucitol, 1-deoxy-1-(methylamino)-, N-C8-10 acyl derivs.
CAS No.: 85316-98-9 and 85261-20-7 (related to main C-chain lengths of the active material)
Physical State: solid, powder
Colour: colourless
Molecular Weight: 321.42 – 349.47 g/mol
Storage Conditions: room temperature

In vivo test system

Test animals

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: 6 - 7 weeks
- Housing: group housing of max. 5 animals per 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): approximately 15 per hour
- Photoperiod (hrs dark / hrs light): 12 hours

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

intradermal and epicutaneous

Vehicle:

water

Induction 2

Concentration / amount:

Intradermal induction = 0.5%
Dermal Induction = 5%
Dermal challenge = 5%

Challenge

Challenge 1

Route:

epicutaneous, occlusive

Vehicle:

water

Challenge 2

Concentration / amount:

Intradermal induction = 0.5%
Dermal Induction = 5%
Dermal challenge = 5%

No. of animals per dose:

10 animals in test group
5 animals in control group

Challenge controls:

Yes

Positive control substance(s):

yes

Remarks:

alpha-hexylcinnamaldehyde

Results and discussion

Positive control results:

The skin reactions observed in all experimental animals in response to the 20% test substance concentration in the challenge phase indicate that the female guinea pig of the Dunkin Hartley strain is an appropriate and sensitive animal model for the evaluation of the skin sensitization potential of chemicals.

In vivo (non-LLNA)

Results

Results 1

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

5%

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: 5%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.

Results 2

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

5%

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: 5%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.

Results 3

Reading:

1st reading

Hours after challenge:

24

Group:

negative control

Dose level:

5%

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: 5%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: none.

Results 4

Reading:

2nd reading

Hours after challenge:

48

Group:

negative control

Dose level:

5%

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: 5%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: none.

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

There was no evidence that the registration substance had caused skin hypersensitivity in the guinea pig, since no responses were observed in the experimental animals in response to a 5% test substance concentration in the challenge phase. From the results it is concluded that the registration substance is not a skin sensitizer.

Executive summary:

The study was performed according to OECD TG 406 and taking into account the principles of GLP. Selection of test substance concentrations for the main study were based on the results of a preliminary study. In the main study, ten experimental animals were intradermally injected with a 0.5% concentration and epidermally exposed (induction treatment) to a 5% concentration. Five control animals were similarly treated, but with vehicle alone (water). Two weeks after the epidermal application all animals were challenged with a 5% test substance concentration and the vehicle. No skin reactions were evident after the challenge exposure in the experimental and control animals. There was no evidence that the registration substance had caused skin hypersensitivity in the guinea pig, since no responses were observed in the experimental animals in response to a 5% test substance concentration in the challenge phase. The sensitization incidence was 0%. From the results of this study, it is concluded that the registration substance is not a skin senitizer.