[No public or meaningful name is available]

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 06 Dec 2016 to 09 Dec 2016

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

1

Reference substance name:

trans-(4-(methylamino)cyclohexyl)methanesulfonic acid

Cas Number:

2124221-12-9

Molecular formula:

C8H17NO3S

IUPAC Name:

trans-(4-(methylamino)cyclohexyl)methanesulfonic acid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Covance Research Products Inc., Denver, PA
- Age at study initiation: The male animal was born on 11 Jun 2016 and the female animals were born on 04 Jun 2016.
- Weight at study initiation: The pre-test body weight range was 3.2 -3.5 kg.
- Housing: The animals were identified by cage notation and a uniquely numbered metal ear tag and individually housed in suspended wire-bottom cages.
- Diet (e.g. ad libitum): Fresh PMI Rabbit Chow (Diet No. 5321) was provided daily.
- Water (e.g. ad libitum): Water was available ad libitum.
- Acclimation period: at least five days

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

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

no

Amount / concentration applied:

0.5 g per site and moistened with 0.4 ml of distilled water to form a pasty consistency.

Duration of treatment / exposure:

3 minutes, 1 hour, 4 hours

Observation period:

72 hours

Number of animals:

one male, two females

Details on study design:

TEST SITE
- Area of exposure: The test article was applied over a 2 x 3 cm gauze patch.
- % coverage:
- Type of wrap if used: Gentle pressure was applied to aid in the distribution of the test article over the prepared site. The dose patch was secured with non-irritating tape and the rabbit was gently held in place.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the test site was gently washed with gauze saturated with distilled water following patch removal.
- Time after start of exposure: 3 minutes, 1 hour, 4 hours

OBSERVATION TIME POINTS
(indicate if minutes, hours or days) Exposure Site 1 of the initial animal was scored for dermal irritation immediately post-exposure and at one hour post-exposure. Sites 2 (one-hour exposure) and 3 (four-hour exposure) were scored for dermal irritation at 1, 24, 48 and 72 hours hours after patch removal.

SCORING SYSTEM:
- Method of calculation: Erythema and edema were scored according to the numerical Draize scale. The skin was also evaluated for ulceration and necrosis or any evidence of tissue destruction.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0.33

Max. score:

1

Reversibility:

fully reversible within: 48 hours

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Other effects:

Systemic Observations: No abnormal physical signs were observed.
Body Weights: One animal gained weight and two animals' weights remained the same by study termination.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test item is not irritating to rabbit skin.

Executive summary:

The study is performed according to OECD Guideline 404 using rabbits. It is concluded the test item is not irritating to rabbit skin.