Quaternary ammonium compounds, bis(C16-18 and C18-unsatd. alkyl)dimethyl, chlorides

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study according to GLP

Cross-reference

Reason / purpose for cross-reference:

read-across source

Reference

Endpoint:

eye irritation: in vivo

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

For details on endpoint specific justification please see read-across report in section 13 or find a link in cross-reference “assessment report”.

Reason / purpose for cross-reference:

read-across: supporting information

Reason / purpose for cross-reference:

assessment report

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

3.7

Max. score:

4

Reversibility:

not fully reversible within: 14 days

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

4

Max. score:

4

Reversibility:

not fully reversible within: 14 days

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

3.7

Max. score:

4

Reversibility:

not fully reversible within: 14 days

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

not fully reversible within: 14 days

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

not fully reversible within: 14 days

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

not fully reversible within: 14 days

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: 1 h

Score:

1

Max. score:

2

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: at all other time points was iris not discernible through opacity

Irritation parameter:

iris score

Basis:

animal #2

Time point:

other: 1 h

Score:

1

Max. score:

2

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other:

Remarks:

at all other time points was iris not discernible through opacity

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

not fully reversible within: 14 d

Remarks on result:

not determinable

Remarks:

at all other time points was iris not discernible through opacity

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

4

Max. score:

4

Reversibility:

not reversible

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

4

Max. score:

4

Reversibility:

not reversible

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

not reversible

Interpretation of results:

highly irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on the results of this study, the test material was severely irritating to eyes (R41 - risk of serious damage to eyes).

Executive summary:

The study used as source investigated eye irritation. The study results of the source compound were considered applicable to the target compound. Justification and applicability of the read-across approach (structural analogue) is outlined in the read-across report in section 13 or find a link in cross reference “assessment report”.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Quaternary ammonium compounds, bis(hydrogenated tallow alkyl)dimethyl, chlorides

EC Number:

263-090-2

EC Name:

Quaternary ammonium compounds, bis(hydrogenated tallow alkyl)dimethyl, chlorides

Cas Number:

61789-80-8

Molecular formula:

R2Me2N(+)Cl(-) whereas R = mainly C16, 18-alkyl molecular weight range is based on R=14 (lower limit value) and R=18 (higher limit value)

IUPAC Name:

N,N-Dimethyl-N,N-di-n-alkyl(C16-18)-ammoniumchloride

Details on test material:

- Name of test material (as cited in study report): Genamin DSAC (Dioctadecyldimethylammonium chloride)
- Physical state: solid
- Radiochemical purity (if radiolabelling): n.a.
- Specific activity (if radiolabelling): n.a.
- Locations of the label (if radiolabelling): n.a.
- Expiration date of radiochemical substance (if radiolabelling): n.a.
- Stability under test conditions: stable
- Storage condition of test material: darkness, room temperature

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG, Germany
- Age at study initiation: ca. 3 - 5 month
- Weight at study initiation: 2.2 - 3.0 kg
- Housing: individually, stainless steel cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days


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

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

100 mg

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

14 days

Number of animals or in vitro replicates:

3

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

3.7

Max. score:

4

Reversibility:

not fully reversible within: 14 days

Results 2

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

4

Max. score:

4

Reversibility:

not fully reversible within: 14 days

Results 3

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

3.7

Max. score:

4

Reversibility:

not fully reversible within: 14 days

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

not fully reversible within: 14 days

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

not fully reversible within: 14 days

Results 6

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

not fully reversible within: 14 days

Results 7

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: 1 h

Score:

1

Max. score:

2

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: at all other time points was iris not discernible through opacity

Results 8

Irritation parameter:

iris score

Basis:

animal #2

Time point:

other: 1 h

Score:

1

Max. score:

2

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other:

Remarks:

at all other time points was iris not discernible through opacity

Results 9

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

not fully reversible within: 14 d

Remarks on result:

not determinable

Remarks:

at all other time points was iris not discernible through opacity

Results 10

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

4

Max. score:

4

Reversibility:

not reversible

Results 11

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

4

Max. score:

4

Reversibility:

not reversible

Results 12

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

not reversible

Applicant's summary and conclusion

Interpretation of results:

highly irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on the results of this study, the test material Genamin DSAC (97% distearyldimethylammonium chloride) was severely irritating to eyes (R41 - risk of serious damage to eyes).

Executive summary:

In an OECD TG 405 study, 100 mg of the test material Genamin DSAC (dioctadecyldimethylammonium chloride), a whitish waxy solid (purity approximately 97%), was applied to the eye of three New Zealand White rabbit. 24 hours after treatment, the eye was washed with 0.9% NaCl solution.The observation period was 14 days. At the one hour reading, the conjunctiva exhibited slight chemosis and injected blood vessels of the conjunctivae. From 24 hours onwards, the conjuctivae showed swellings with lids more than half closed and a diffuse crimson red colour. In two animals the cornea was opaque with the iris not discernible. The remaining animals exhibited moderate opacity of the cornea and obvious congestion of the iris. Additionally, a clear colourless to whitish-slimy discharge was noted. After 14 days in one animal a deformation of the eyeball was observed. According to the results of the study the test substance Genamin DSAC has to be regarded as irritating (Xi – R41- Risk of serious damage to eyes) in compliance with the criteria laid down in 83/467/EWG.