[No public or meaningful name is available]

Skin irritation / corrosion

Administrative data

Endpoint:

skin corrosion: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

31st August 2016 to 1st September 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

Standard Data required for the purpose of REACH registration

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 430 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test Method (TER))

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

D-fructose and D-glucose and reaction products of D-fructose and D-glucose and hexamethylenediamine

IUPAC Name:

D-fructose and D-glucose and reaction products of D-fructose and D-glucose and hexamethylenediamine

Test material form:

liquid

In vitro test system

Test system:

isolated skin discs

Source species:

rat

Source strain:

Wistar

Details on animal used as source of test system:

One female Wistar (RccHan:WIST) strain rat supplied by Envigo RMS (UK) Limited. 21-23 days old. Hosed in solid-floor polypropylene cage furnished with wood flakes. Free access to mains drinking water and food (2014C Teklad Global rodent diet). Two days of acclimatization.

Justification for test system used:

In accordance with OECD Testing Guideline

Vehicle:

unchanged (no vehicle)

Details on test system:

Skin disk Preparation
After two days of acclimatization the rat was shaved to remove hair from the dorsal surface. The skin was washed with antibiotic wash then washed again after a further 3 days. The animal was killed two days later using ascending concentrations of carbon dioxide followed by cervical dislocation. Little to no hair growth was visible. The dorsal skin was removed as a single pelt. Excess fat was removed and the pelt mounted, epidermal side uppermost, onto a PTFE tub. The tissue was secured with an "O" ring trimmed and sealed with soft paraffin wax. The tube was supported by a clamp inside a labeled 30 mL glass receptacle containing 10 mL electrolyte solution (154 mM MgSO4)

Skin Disc Quality control
Two disks of skin of approximately 0.79 cm2 were taken from the pelt and the TER measured as a quality control procedure. Each disk had to give a resistance value of greater than 10 KΩ in order for the remainder of the pelt to be uses in the assay.

Removal of test material and control
At end of exposure period the test item was removed by washing the skin disc with a jet of warm tap water until no further test item could be removed.

Number of independent testing runs
3 replicates for the test item as well as the positive and negative controls

Decision criteria
The test substance is considered to be non-corrosive to skin if the mean TER value obtained for the test substance after 24 hour contact period is greater than 5 kΩ

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

Test item administered as supplied (no vehicle). A volume of 150 µL was applied to the inner epidermal surface using an automatic pipettor

Negative control : Sterile distilled water. A volume of 150 µL was applied to the inner epidermal surface using an automatic pipettor

Positive control: 10 M HCl. A volume of 150 µL was applied to the inner epidermal surface using an automatic pipettor

Duration of treatment / exposure:

24 hours

Duration of post-treatment incubation (if applicable):

not applicable

Number of replicates:

3

Test animals

Species:

rat

Strain:

Wistar

Details on test animals or test system and environmental conditions:

One female Wistar (RccHan:WIST) strain rat supplied by Envigo RMS (UK) Limited. 21-23 days old. Housed in solid-floor polypropylene cage furnished with wood flakes. Free access to mains drinking water and food (2014C Teklad Global rodent dient). Two days of acclimatization. The diet, drinking water and bedding were routinely analyzed and were considered not to contain any contaminants that would reasonably be expected to affect the purpose or integrity of the study.

The temperature and relative humidity were set to achieve limits of 10 to 25 °C and 30 to 70% respectively. The rate of air exchange was at least fifteen changes per hour and the lighting was controlled by a time switch to give 12 hours continuous light and 12 hours darkness. The animal was provided with environmental enrichment items which were considered not to contain any contaminants of a level that might have affected the purpose or integrity of the study.

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

transcutaneous electrical resistance (in kΩ)

Value:

25.8

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Other effects / acceptance of results:

Negative control: Acceptance criteria 10-25 kΩ. Mean result of 3 replicates 20.9 kΩ (± 1.9)
Positive control: Acceptance criteria 0.5-1.0 kΩ. Mean result of 3 replicates 866.7 Ω (± 89)
Sample test: Mean result of 3 replicates 25.8 kΩ (± 10.8)

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test item was considered unlikely to have the potential to cause corrosion in vivo.

Executive summary:

The skin corrosion potential of pre-reacted hexamethylenediamine and glucose/fructose in high solids binder was evaluated using OECD Guideline 430 ( In vitro skin Corrosion:Transcutaneous Electrical Resistance Test" (adopted 28th July 2015)). The test was GLP compliant.

Triplicate skin samples were treated with 150 µL of pre-reacted hexamethylenediamine and glucose/fructose in high solids binder. additional triplicate skin sample were treated with 150 µL sterile water (negative control) and 150 µL of 10M hydrochloric acid (positive control). All controls were valid and demonstrated the reliability of the test system.

The mean results for the test substance was >5 k Ω (25.8 k Ω ) and as such the test item was considered unlikely to have the potential to cause corrosion in vivo.