Dimantine

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Study period:

11 Apr 1989 to 25 Apr 1989

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Dimethyl(tetradecyl)amine

EC Number:

204-002-4

EC Name:

Dimethyl(tetradecyl)amine

Cas Number:

112-75-4

Molecular formula:

C16H35N

IUPAC Name:

N,N-dimethyltetradecan-1-amine

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: HOECHST AG, Kastengrund, Germany
- Age at study initiation: 3-5 months
- Weight at study initiation: approx. 2.6 kg
- Housing: individually
- Diet (ad libitum): Altromin 2123 Haltungsdiät - Kaninchen (Altromin-GmbH, Lage/Lippe, Germany) and 15 g hay per day
- Water (ad libitum): eionised, chlorinated water

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 50 +/- 20
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye served as internal control

Amount / concentration applied:

0.1 mL

Duration of treatment / exposure:

24 h

Observation period (in vivo):

Ocular reactions were assessed 1, 24, 48 and 72 hours after treatment, and on Days 7 and 14

Number of animals or in vitro replicates:

1

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with warm (37 °C) physiological saline
- Time after start of exposure: 24 h after application, at time points with observed discharge and before treatment with fluorescein

SCORING SYSTEM: according to guidelines

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: examination by fluorescein revealed no effects

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

other: reddening 1 h post application

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

1.7

Max. score:

3

Reversibility:

fully reversible within: 14 days

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

3.7

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritant / corrosive response data:

The iris of the treated eye was reddened 1 h post application. A colourless discharge was also observed at this time point.The conjunctiva showed swelling up to 72 h, with half closed or more than half closed lids, and hyperaemia of blood vessels up to a diffuse crimson discolouration.
Eschar formation was observed on the skin around the eye at >/= 72 h post application, after 7 to 14 days approx. 2 cm of the surrounding area, accompanied by hardening of the skin and total hair loss at the end of the study. After detaching of eschar the skin showed a pergament-like, coarsely porous appearance. The hair roots seemed to be irreversibly damaged.

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye)

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of this test, the substance was not classified formally, but as producing irreversible effects on the eyes (due to severe effects on eye-surrounding skin).

Executive summary:

The eye-irritating properties were examined in a test according to guideline OECD 405 and EU B.5. 0.1 mL of the test substance were applied to the left eye of one New Zealand white rabbit. The untreated eye served as internal control. Effects were evaluated 1 h (after removing the test substance by washing with warm physiological saline), 24, 48 and 72 hours post application and on day 7 and 14.

The iris of the treated eye was reddened 1 h post application. A colourless discharge was also observed at this time point. The conjunctiva showed swelling up to 72 h, with half closed or more than half closed lids, hyperaemia of blodd vessels to a diffuse crimson discolouration. Eschar formation was observed on the skin around the eye at >/= 72 h post application, after 7 to 14 days approx. 2 cm of the surrounding area, accompanied by hardening of the skin and total hair loss at the end of the study. After detaching of eschar the skin showed a pergament-like, coarsely porous appearance. The hair roots seemed to be irreversibly damaged. Fluorescein staining revealed no opacity of the cornea. Due to the severe effects on the skin surrouunding the eye, these results were interpreted as irreversible damage.