Reaction mass of N,N-dimethyldecan-1-amide and N,N-dimethyloctanamide

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Well conducted and documented study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: enforcement of the Federal Insecticide, Fungicide, and Rodenticide Act (40 CFR), the Toxic Substances Control Act (40 CFR)

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

with the exception of the nurnber of animals employed for testing

Principles of method if other than guideline:

Due to the suspected irritation potential of this test material, a single animal was initiated on this primary eye irritation study.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Hallcomid M-8-10

IUPAC Name:

Hallcomid M-8-10

Constituent 2

Reference substance name:

Decanamide, N,N-dimethyl-, mixt. with N,N-dimethyloctanamide

Cas Number:

67359-57-3

IUPAC Name:

Decanamide, N,N-dimethyl-, mixt. with N,N-dimethyloctanamide

Details on test material:

- Name of test material (as cited in study report):HALLCOMlD M-8-10
- Substance type: mixture of dimethylamides
- Physical state: liquid, clear, golden-tinted
- Stability under test conditions: stable at room temperature
- Storage condition of test material: room temperature

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source:The animals were purchased from a U.S.D.A approved supplier
- Housing: Animals were housed slngly in wire mesh suspension cages
- Diet (e.g. ad libitum):PURINA LABORATORY RABBIT CHOW (or ether comparable diet), ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: at least 1 day

ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12h each

Preparation of animals:
Within approximately twenty four hours of test material applieation, eyes will be examined using fluorescein dye. One drop of Fluorescein Sodium Ophthalmie Solution U.S.P. or equivalent will be applied directly to the cornea. After flushing out the excess fluorescein with Sodium Chloride Solution
U.S.P. or equivalent, the corneas will be visualized under ultraviolet illumination. Any anlmal exhibltlng pre-existing defects or irritation which could compromise the validity ot the study will not be used.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye serves as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1ml

Duration of treatment / exposure:

24h

Observation period (in vivo):

1h, 24h, 48h, 72h and 4 days

Number of animals or in vitro replicates:

1

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24h

SCORING SYSTEM: draize

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: average of 24h, 48h and 72h reading

Score:

1.7

Max. score:

4

Reversibility:

not fully reversible within: 4 days

Results 2

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: average of 24h, 48h and 72h reading

Score:

1

Max. score:

2

Reversibility:

not fully reversible within: 4 days

Results 3

Irritation parameter:

conjunctivae score

Remarks:

erythema

Basis:

animal #1

Time point:

other: average of 24h, 48h and 72h reading

Score:

2.7

Max. score:

3

Reversibility:

not fully reversible within: 4 days

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: average of 24h, 48h and 72h reading

Score:

4

Max. score:

4

Reversibility:

not fully reversible within: 4 days

Irritant / corrosive response data:

The test material produced corneal opacity, iritis, and conjunctival irritation
persisting for the 4 day duration of this test.
No evidence of corrosion was noted in the animal.

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye)

Remarks:

Migrated information Criteria used for interpretation of results: other: EU GHS

Conclusions:

Irreversible eye effects possible

Executive summary:

The primary ocular irritancy of HALLCOMID M-8-10 was evaluated in compliance with the conditions specified in the regulation for the enforcement of the Federal Insecticide, Fungicide, and Rodenticide Act (40 CFR), the Toxic Substances Control Act (40 CFR), and the OECD Guidelines with the exception of the number of animals employed for testing. One New Zealand White rabbit was exposed to 0.1ml test substance and gradings were scored after 1h, 24h, 48h, 72h and 4 days. Due to the suspected irritation potential of this test material, a single animal was initiated on this primary eye irritation study. Due to the effects exhibited in this single animal, this study was ultimately terminated without testing in additional animals.

The test material produced corneal opacity, iritis, and conjunctival irritation persisting for the 4 day duration of this test when applied without rinsing to the eye of one New Zealand White rabbit. In addition, corneal vascularization becarne apparent at day 4.

Irritation scores in the one animal are: cornea score 1.7, iris score 1, conjunctivia 2.7 and chemosis 4.

No evidence of corrosion was noted in the animal.

Based on this result the substance has to be labelled as Cat 1 irreversible eye effects according to EU GHS EC 1272/2008.