Reaction mass of 2-hydroxy-3-[(1-oxodocosyl) oxy]propyltrimethylammonium chloride and 2-methylpentane-2,4-diol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1981

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

No details on test substance, test animals and environmental conditions.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

no details on test substance, test animals and environmental conditions.

Principles of method if other than guideline:

Not applicable

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-hydroxy-3-[(1-oxodocosyl)oxy]propyltrimethylammonium chloride

EC Number:

274-033-6

EC Name:

2-hydroxy-3-[(1-oxodocosyl)oxy]propyltrimethylammonium chloride

Cas Number:

69537-38-8

Molecular formula:

C28H58NO3.Cl

IUPAC Name:

3-(docosanoyloxy)-2-hydroxy-N,N,N-trimethylpropan-1-aminium chloride

Constituent 2

Reference substance name:

2-methylpentane-2,4-diol

EC Number:

203-489-0

EC Name:

2-methylpentane-2,4-diol

Cas Number:

107-41-5

Molecular formula:

C6H14O2

IUPAC Name:

2-methylpentane-2,4-diol

Test material form:

solid

Remarks:

paste

Details on test material:

- Description: White pasty product
- Date of receipt: 10 September 1980

Specific details on test material used for the study:

Test substance was tested pure and undiluted

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Housing: Animals were caged individually.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye served as control

Amount / concentration applied:

TEST MATERIAL
- Concentration: Undiluted

Duration of treatment / exposure:

Eyes were not washed following instillation of test substance.

Observation period (in vivo):

24 and 72 h after the application of the test substance

Number of animals or in vitro replicates:

6 animals

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): No

SCORING SYSTEM: Skin reactions were evaluated by the method of Draize.

TOOL USED TO ASSESS SCORE: Ocular reactions were read using a binocular magnifying glass.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

6 animals

Time point:

24/48 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

6 animals

Time point:

24/48 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48 h

Score:

0.5

Max. score:

3

Reversibility:

fully reversible within: 48 h

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

5 animals (# 2,3,4,5,6)

Time point:

24/48 h

Score:

0

Max. score:

3

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Results 5

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48 h

Score:

0.5

Max. score:

4

Reversibility:

fully reversible within: 48 h

Remarks on result:

no indication of irritation

Results 6

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

5 animals (# 2,3,4,5,6)

Time point:

24/48 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Test substance caused slight conjunctivitis in one out of six rabbits. After 48 hours these lesions had cleared up.

Other effects:

None

Any other information on results incl. tables

Table 7.3.2/1: Individual and average ocular lesion scores

Rabbit No.	Cornea	Iris	Conjunctivae
			redness	Chemosis
24 hours
13	0	0	1	1
14	0	0	0	0
15	0	0	0	0
16	0	0	0	0
17	0	0	0	0
18	0	0	0	0
48 hours
13	0	0	0	0
14	0	0	0	0
15	0	0	0	0
16	0	0	0	0
17	0	0	0	0
18	0	0	0	0
Mean (24 and 48 h)	0	0	0.08	0.08

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the test conditions, the test substance is not classified as irritant to the eyes according to the criteria of the annex VI of the Regulation EC No. 1272/2008 (CLP) and to the GHS.

Executive summary:

In an eye irritation study, undiluted test substance was instilled into one eye of 6 New Zealand White rabbits while the untreated eye served as control. The eyes were not rinsed after the instillation of test substance. Animals were observed at 24 and 48 h after instillation of test substance into eyes. The reactions in the conjunctivae (redness and chemosis), the iris and the cornea were scored according to the Draize scale.

Test substance caused slight conjunctivitis in one out of six rabbits. The observed conjunctival reactions were disappeared completely within 48 hours. The calculated mean score for 6 animals (24 and 48 h) were 0.08 for redness, 0.08 for chemosis, 0.0 for iris lesions and 0.0 for corneal opacity.

Under the test conditions, the test substance is not classified as irritant to the eyes according to the criteria of the annex VI of the Regulation EC No. 1272/2008 (CLP) and to the GHS.

Although some details on test animals and experimental conditions were missing, this study is considered as acceptable and satisfies the requirement for eye irritation endpoint.