Quaternary ammonium compounds, C18-22 (even numbered) alkyltrimethyl, chlorides; Docosyltrimethylammonium chloride; C18-22 TMAC

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From April 23, 2008 to April 24, 2008

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

The body weight of the animal was not determined after sacrifice. Evaluation: Sufficient data was available to assess the possible irritation or corrosion potential of the test substance. The study integrity was not adversely affected by the deviations.

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

yes

Remarks:

The body weight of the animal was not determined after sacrifice. Evaluation: Sufficient data was available to assess the possible irritation or corrosion potential of the test substance. The study integrity was not adversely affected by the deviations.

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2400 (Acute Eye Irritation)

Deviations:

yes

Remarks:

The body weight of the animal was not determined after sacrifice. Evaluation: Sufficient data was available to assess the possible irritation or corrosion potential of the test substance. The study integrity was not adversely affected by the deviations.

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: JMAFF guidelines (2000) including the most recent partial revisions

Deviations:

yes

Remarks:

The body weight of the animal was not determined after sacrifice. Evaluation: Sufficient data was available to assess the possible irritation or corrosion potential of the test substance. The study integrity was not adversely affected by the deviations.

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Quaternary ammonium compounds, C20-22-alkyltrimethyl, chlorides

EC Number:

271-756-9

EC Name:

Quaternary ammonium compounds, C20-22-alkyltrimethyl, chlorides

Cas Number:

68607-24-9

Test material form:

solid

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Harlan France SARL, Gannat, France
- Age at study initiation: 10-12 weeks old
- Weight at study initiation: 2215 g
- Housing: Individually in labeled cages with perforated floors (dimensions 56x44x37.5 cm).
- Diet (e.g. ad libitum): Pelleted diet for rabbits approximately 100 grams per day. Hay was provided at least three times a week
- Water (e.g. ad libitum): Free access to tap water
- Acclimation period: 5 days before start of treatment under laboratory conditions


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.3 – 21.3
- Humidity (%): 45 - 55
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: The other eye remained untreated and served as the reference control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 64.9 mg (volume of approx. 0.1mL)

Duration of treatment / exposure:

24 h

Observation period (in vivo):

1 and 24 hours after instillation of the test substance

Number of animals or in vitro replicates:

1 (male)

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not done

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Remarks:

opacity

Basis:

animal #1

Time point:

other: 1 h

Score:

1

Max. score:

4

Reversibility:

not reversible

Remarks:

Within 24 h

Results 2

Irritation parameter:

cornea opacity score

Remarks:

opacity

Basis:

animal #1

Time point:

24 h

Score:

2

Max. score:

4

Reversibility:

fully reversible

Remarks:

within 24 h

Results 3

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: 1 h

Score:

1

Max. score:

2

Reversibility:

not reversible

Remarks:

within 24 h

Results 4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24 h

Score:

1

Max. score:

2

Reversibility:

not reversible

Remarks:

within 24 h

Results 5

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #1

Time point:

other: 1 h

Score:

3

Max. score:

3

Reversibility:

not reversible

Remarks:

within 24 h

Results 6

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #1

Time point:

24 h

Score:

3

Max. score:

3

Reversibility:

not reversible

Remarks:

within 24 h

Results 7

Irritation parameter:

conjunctivae score

Remarks:

chemosis

Basis:

animal #1

Time point:

other: 1 h

Score:

4

Max. score:

4

Reversibility:

not reversible

Remarks:

within 24 h

Results 8

Irritation parameter:

conjunctivae score

Remarks:

chemosis

Basis:

animal #1

Time point:

24 h

Score:

4

Max. score:

4

Reversibility:

not reversible

Remarks:

within 24 h

Results 9

Irritation parameter:

conjunctivae score

Remarks:

discharge

Basis:

animal #1

Time point:

other: 1 h

Score:

3

Reversibility:

not reversible

Remarks:

within 24 h

Results 10

Irritation parameter:

conjunctivae score

Remarks:

discharge

Basis:

animal #1

Time point:

24 h

Score:

3

Reversibility:

not reversible

Remarks:

within 24 h

Results 11

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

48 h

Remarks on result:

not measured/tested

Results 12

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

72 h

Remarks on result:

not measured/tested

Results 13

Irritation parameter:

iris score

Basis:

mean

Time point:

48 h

Remarks on result:

not measured/tested

Results 14

Irritation parameter:

iris score

Basis:

mean

Time point:

72 h

Remarks on result:

not measured/tested

Results 15

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

48 h

Remarks on result:

not measured/tested

Results 16

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

72 h

Remarks on result:

not measured/tested

Results 17

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

not measured/tested

Irritant / corrosive response data:

Instillation of approximately 65 mg of the test substance (a volume of approximately 0.1 mL) into an eye of one rabbit resulted in effects on the cornea, iris and conjunctivae. The corneal injury consisted of opacity (maximum grade 2) and epithelial damage (100% of the corneal area). Iridial irritation grade 1 was observed and the irritation of the conjunctivae consisted of redness, chemosis and discharge. Grey/white discoloration of the eyelids and nictating membrane (a sign of necrosis) was noted. Erythema and oedema of the outside of the eyelids was noted. Based on the severity of the ocular lesions observed during the study, the animal was sacrificed for ethical reasons immediately after the 24 hours observation and the two further rabbits assigned to the study were not treated.

Other effects:

Remnants of the test substance were present in the eye on Day 1. No staining of (peri) ocular tissues by the test substance was observed. No symptoms of systemic toxicity were observed in the animal until the animal was sacrficed due to severe ocular effects.

Applicant's summary and conclusion

Interpretation of results:

other: Eye Damage 1 (causes serious eye damage) based on CLP criteria

Conclusions:

Under the study conditions, the test substance was considered to be causes serious eye damage to rabbit eyes.

Executive summary:

A study was conducted to determine the eye irritation/corrosion of the test substance, C20-22 TMAC (active: 97.8%), according to OECD Guideline 405 and EU Method B.5, in compliance with GLP. In the study, 65 mg (approx. 0.1mL) of the test substance was instilled into an eye of one rabbit. The test sites were examined for evidence of irritation and scored according to Draize method. Observations were made 1 and 24 h after instillation. Instillation of the test substance resulted in effects on the cornea, iris and conjunctivae. The corneal injury consisted of opacity (maximum grade 2) and epithelial damage (100% of the corneal area). Iridial irritation grade 1 was observed and the irritation of the conjunctivae consisted of redness, chemosis and discharge. Grey/white discoloration of the eyelids and nictating membrane (a sign of necrosis) was noted. Erythema and oedema of the outside of the eyelids was noted. Based on the severity of the ocular lesions observed during the study, the animal was sacrificed for ethical reasons immediately after the 24 h observation and the two further rabbits assigned to the study were not treated. Under the study conditions, the test substance was considered to be causes serious eye damage to rabbit eyes (Stitzinger, 2008).