4,5-dihydro-2-undecyl-1H-imidazole-1-ethanol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

October 1978

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study on analogue substance used. Method differing from current OECD guideline/EC method (longer application period, occlusive patch), prior to GLP. Limited reporting details available.

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:

other: Consumer Product Safety Commission 16 CFR Ch. II § 1500.41

GLP compliance:

no

Remarks:

Prior to GLP principles

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, coco, reaction products with 2-[(2-aminoethyl)amino]ethanol

EC Number:

267-058-9

EC Name:

Fatty acids, coco, reaction products with 2-[(2-aminoethyl)amino]ethanol

Cas Number:

67784-90-1

IUPAC Name:

Fatty acids, coco, reaction products with 2-[(2-aminoethyl)amino]ethanol

Test animals

Species:

rabbit

Strain:

other: no data, albino rabbits

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: no data
- Housing: animals immobilized in racks for a 24-h period during the application.
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

IN-LIFE DATES: no data

Test system

Type of coverage:

occlusive

Preparation of test site:

other: shaved. One site left intact and one site was abraded

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml per site
- Concentration (if solution): as is

VEHICLE
no vehicle

Duration of treatment / exposure:

24 hours

Observation period:

Observations at the end of the 24-hour contact period and again 48 hours later.

Number of animals:

3 rabbits

Details on study design:

TEST SITE
- Area of exposure: no data
- % coverage: ca. 10%
- Type of wrap if used: webril patches over the treated area and the entire experimental area sealed with Blenderm surgical tape.

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

SCORING SYSTEM: Draize scale

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24-72 hrs

Score:

3.5

Max. score:

4

Reversibility:

no data

Remarks:

(not assessed)

Remarks on result:

other: For intact skin sites

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24-72 hrs

Score:

1.5

Max. score:

4

Reversibility:

no data

Remarks:

(not assessed)

Remarks on result:

other: For intact skin sites

Results 3

Irritation parameter:

primary dermal irritation index (PDII)

Score:

5

Max. score:

8

Reversibility:

no data

Remarks:

(not assessed)

Remarks on result:

other: (intact and abraded skin)

Irritant / corrosive response data:

Severe primary irritant.

Other effects:

no data.

Applicant's summary and conclusion

Interpretation of results:

highly irritating

Remarks:

Migrated information

Conclusions:

Limited details available for interpretation according to current criteria, but severe effects were observed on intact skin sites.