Imidazolium compounds, 1-[2-(2-carboxyethoxy)ethyl]-1(or 3)-(2-carboxyethyl)-4,5-dihydro-2-norcoco alkyl

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

no specified (1978)

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

Occlusive dressing instead of non-occlusive. Half of the treated area was abraded. The animals were exposed for 24 hours instead of 4 hours and observed for 72 hours instead of 14 days.

GLP compliance:

no

Test material

Test material information

1

Reference substance name:

Imidazolium compounds, 1-[2-(2-carboxyethoxy)ethyl]-1(or 3)-(2-carboxyethyl)-4,5-dihydro-2-norcoco alkyl

EC Number:

272-897-9

EC Name:

Imidazolium compounds, 1-[2-(2-carboxyethoxy)ethyl]-1(or 3)-(2-carboxyethyl)-4,5-dihydro-2-norcoco alkyl

Cas Number:

68919-40-4

Molecular formula:

R_C8 H14 N2 O4 Na With R=Cn H2n+1 n=8, 10, 12, 14, 16, 18

IUPAC Name:

disodium 3-({2-[N-(2-hydroxyethyl)hexadecanamido]ethyl}amino)propanoate 3-[(2-hexadecanamidoethyl)(2-hydroxyethyl)amino]propanoate

Test material form:

solid - liquid: aqueous solution

Details on test material:

- Batch No.: 4324D78

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Batch No.of test material: 4324D78
- Expiration date of the lot/batch: not specified
- Purity test date: not specified

Test animals

Species:

rabbit

Strain:

other: albino rabbit

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: not specified
- Age at study initiation: not specified
- Weight at study initiation: not specified
- Housing: in racks
- Diet (e.g. ad libitum): not specified
- Water (e.g. ad libitum): not specified
- Acclimation period: not specified

ENVIRONMENTAL CONDITIONS
- Temperature (°C): not specified
- Humidity (%): not specified
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): not specified

IN-LIFE DATES: not specified

Test system

Type of coverage:

occlusive

Preparation of test site:

other: clipped and abraded areas

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL on each area (scarified and unscarified)

Duration of treatment / exposure:

24 hours

Observation period:

72 hours

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure:
- % coverage: 10% of the total body area was clipped free of hair the day prior the exposure. The test article was applied to a 2.0 x 2.0 cm clipped area of both intact and abraded skin
- Type of wrap if used: The 2 x 2 patch area was covered with Webril patches and the entire experimental area sealed with Blenderm Surgical Tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing
- Time after start of exposure: 24 hours

OBSERVATION TIME POINTS : 24 and 72 jours

SCORING SYSTEM:
- Method of calculation: Draize

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Remarks:

Intact skin

Basis:

mean

Remarks:

mean score of the 3 animals (individual scores of each animal were not reported in the study report)

Time point:

24 h

Score:

2

Reversibility:

not specified

Remarks:

Skin reactions were still observed after the 72-hours observation period.

Remarks on result:

probability of mild irritation

Results 2

Irritation parameter:

erythema score

Remarks:

intact skin

Basis:

mean

Remarks:

mean score of the 3 animals (individual scores of each animal were not reported in the study report)

Time point:

72 h

Score:

1

Reversibility:

not specified

Remarks:

Skin reactions were still observed after the 72-hours observation period.

Remarks on result:

probability of weak irritation

Results 3

Irritation parameter:

erythema score

Remarks:

abraded skin

Basis:

mean

Remarks:

mean score of the 3 animals (individual scores of each animal were not reported in the study report)

Time point:

24 h

Score:

2

Reversibility:

not specified

Remarks:

Skin reactions were still observed after the 72-hours observation period.

Remarks on result:

probability of mild irritation

Results 4

Irritation parameter:

erythema score

Remarks:

abraded skin

Basis:

mean

Remarks:

mean score of 3 animals (individual scores of each animal were not reported in the study report)

Time point:

72 h

Score:

1

Reversibility:

not specified

Remarks:

Skin reactions were still observed after the 72-hours observation period.

Remarks on result:

probability of weak irritation

Results 5

Irritation parameter:

edema score

Remarks:

intact skin

Basis:

mean

Remarks:

mean score of the 3 animals (individual scores of each animal were not reported in the study report)

Time point:

24 h

Score:

1

Reversibility:

not specified

Remarks:

Skin reactions were still observed after the 72-hours observation period.

Remarks on result:

probability of weak irritation

Results 6

Irritation parameter:

edema score

Remarks:

intact skin

Basis:

mean

Remarks:

means score of the 3 animals (individual scores of each animal were not reported in the study report)

Time point:

72 h

Score:

0

Reversibility:

not specified

Remarks:

Skin reactions were still observed after the 72-hours observation period.

Remarks on result:

no indication of irritation

Results 7

Irritation parameter:

edema score

Remarks:

abraded skin

Basis:

mean

Remarks:

mean score of the 3 animals (individual scores of each animal were not reported in the study report)

Time point:

24 h

Score:

1

Reversibility:

not specified

Remarks:

Skin reactions were still observed after the 72-hours observation period.

Remarks on result:

probability of weak irritation

Results 8

Irritation parameter:

edema score

Remarks:

abraded skin

Basis:

mean

Remarks:

mean score of the 3 animals (individual scores of each animal were not reported in the study report)

Time point:

72 h

Score:

0

Reversibility:

not specified

Remarks:

Skin reactions were still observed after the 72-hours observation period.

Remarks on result:

no indication of irritation

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on an in vivo skin irritation test in rabbits, the registered substance is not be classified as a skin irritant according to CLP and GHS UN criteria.

Executive summary:

The registered substance (product name = MIRANOL C2M Anhydrous Acid) has been tested for acute skin irritation in 3 New Zealand White rabbits. The test article, a liquid, was applied in a single dermal dose of 0.5 ml to a 2.0 x 2.0 cm clipped area of both intact and abraded skin, under an occlusive dressing for a 24-hour exposure period. Cutaneous examinations were performed at 24 hours, at removal of the dressing, and then at 72 hours.

 

Both on intact and abraded skin, the average score calculated over the 3 animals at 24 hours was 2.0 for erythema, and 1.0 at 72 hours. Oedema reaction was observed at 24 hours on both intact or abraded skin areas, but the reaction had cleared by 72 hours. The average score calculated over the 3 animals at 24 hours was 1.0 for both intact skin and abraded skin areas.

 

Considering the maximalized conditions of application (occlusive application during 24 hours), and the mild cutaneous reactions observed under these conditions, it can be concluded that the registered substance is not be classified as a skin irritant according to CLP and GHS UN criteria.