[No public or meaningful name is available]

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

Study not GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

N,N,N-trimethyl-C12-14 (even numbered)-alkyl-1-aminium chloride

Molecular formula:

C15H34Cl1N1 (representative molecular formula of C12 chain)

IUPAC Name:

N,N,N-trimethyl-C12-14 (even numbered)-alkyl-1-aminium chloride

Constituent 2

Reference substance name:

Water

EC Number:

231-791-2

EC Name:

Water

Cas Number:

7732-18-5

Molecular formula:

H2O

IUPAC Name:

Dihydrogen oxide

Test material form:

liquid

Specific details on test material used for the study:

- Präpagen 2916 (Hoe S 2916)
- Composition: ca. 40% C12-14 alkylmethylammonium chloride, ca. 1% amine/aminehydrochloride with mentioned C chain, ca. 1% salt, ca. 60% water
- Form: Clear liquid
- Storage: in the dark at 2°C

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG, conventional breeding
- Weight at study initiation: 2.2 - 2.5 kg
- Housing: individual cages in climatised room
- Diet (e.g. ad libitum): ERKA Z 6000 (Robert Koch oHG, Germany)
- Water (e.g. ad libitum): deinosed chlorinated water
Lighting: 12 h daily

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24°C
- Humidity (%): 30-70%

Test system

Controls:

other: Untreated eye served as control

Amount / concentration applied:

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

Duration of treatment / exposure:

24 h

Observation period (in vivo):

7 d

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with physiological saline at 37°C
- Time after start of exposure: 24 h

SCORING SYSTEM: as per OECD guideline

TOOL USED TO ASSESS SCORE: biomicroscope

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 2.1

Max. score:

4

Reversibility:

not fully reversible within: 7 d

Remarks on result:

positive indication of irritation

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 1.3

Max. score:

4

Reversibility:

not fully reversible within: 7 d

Remarks on result:

positive indication of irritation

Results 3

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 2.1

Max. score:

4

Reversibility:

not fully reversible within: 7 d

Remarks on result:

positive indication of irritation

Results 4

Irritation parameter:

conjunctivae score

Remarks:

(swelling)

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 3.2

Max. score:

4

Reversibility:

not fully reversible within: 7 d

Remarks on result:

positive indication of irritation

Results 5

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

not measured/tested

Irritant / corrosive response data:

Corneal opacity was observed in all animals at the 1 h time point and was still present after 7 d when vascularisation of the cornea was also seen in 2/3 rabbits. Effects on the iris appeared after 1 h and increased in intensity until the 7 d timepoint when they were still scored at 2 in all rabbits. Conjunctival redness and swelling was also present from 1 h to the end of the study, with no reversibility of the symptoms. After 7 d, the nictating membrane was milky in all treated eyes. There was also bleeding of the conjunctiva and hair loss in a large area around the eyes.

Any other information on results incl. tables

Individual results are presented in the attachment entitled 'Präpagen eye irritation'.

Applicant's summary and conclusion

Interpretation of results:

other: Category 1 (irreversible effects on the eye) based on CLP criteria

Conclusions:

Under the study conditions, the test substance was considered to be severely irritating to eyes.

Executive summary:

A study was conducted to determine the eye irritation potential of the test substance, C12-14 TMAC (active ingredient 40%) in rabbit, according to OECD 405 Guideline. Three New Zealand White rabbits were exposed to undiluted substance (i.e., 40% test substance) applied as a 0.1 mL drop in the left conjunctival sack. The right eye was untreated and served as control. After 24 h of exposure, the eyes were gently washed with physiological saline solution at 37°C. Observations for corneal opacity, effects on the iris and conjunctival reddening/swelling were made 1, 4, 24, 48 and 72 h after eye washing, then after 7 d. Corneal opacity was observed in all animals at the 1 h time point and was still present after 7 d when vascularisation of the cornea was also seen in 2/3 rabbits. Effects on the iris appeared after 1 h and increased in intensity until the 7 d timepoint when they were still scored at 2 in all rabbits. Conjunctival redness and swelling was also present from 1 h to the end of the study, with no reversibility of the symptoms. After 7 d, the nictating membrane was milky in all treated eyes. There was also bleeding of the conjunctiva and hair loss in a large area around the eyes. Under the study conditions, the test substance was considered to be severely irritating to eyes (Jung and Weigand, 1982).