reaction mass of 1-chloro-3-(dodecyloxy)propan-2-ol andalpha-dodecyl-omega-hydroxy-di[oxy[(chloromethyl)-1,2-ethanediyl]] andalpha-dodecyl-omega-hydroxy-tri[oxy[(chloromethyl)-1,2-ethanediyl]]

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

28 November - 09 December 2006

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study conducted in compliance with OECD Guideline 405 with minor deviations: the temperature and relative humidity recorded in the animal room was sometimes outside of the target ranges; individual animal weights not reported.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

the temperature and relative humidity recorded in the animal room was sometimes outside of the target ranges; individual animal weights not reported.

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

version of 29th April 2004

Deviations:

yes

Remarks:

room temperature and relative humidity was sometimes ouside of the target ranges; individual animal weights not reported

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

reaction mass of 1-chloro-3-(dodecyloxy)propan-2-ol and alpha-dodecyl-omega-hydroxy-di[oxy[(chloromethyl)-1,2-ethanediyl]] and alpha-dodecyl-omega-hydroxy-tri[oxy[(chloromethyl)-1,2-ethanediyl]]

Cas Number:

63727-39-9

Molecular formula:

C15H31ClO2 C18H36Cl2O3 C21H41Cl3O4

IUPAC Name:

reaction mass of 1-chloro-3-(dodecyloxy)propan-2-ol and alpha-dodecyl-omega-hydroxy-di[oxy[(chloromethyl)-1,2-ethanediyl]] and alpha-dodecyl-omega-hydroxy-tri[oxy[(chloromethyl)-1,2-ethanediyl]]

Test material form:

other: liquid

Details on test material:

- Physical state: Thick colorless to pale yellow liquid
- Date of receipt: 12 October 2006
- Expiration date of the lot/batch: 04 October 2007
- Storage condition of test material: Room temperature
- pH of the undiluted test item, measured (paper pH), was approximately 1.

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Grimaud frères selection S.A.S., Roussay, France.
- Age at study initiation: 2-4 months
- Weight at study initiation: 2.9 ± 0.2 kg
- Housing: Animals were housed individually in Pajon cages (50 cm x 57 cm x 75 cm).
- Diet: Control Reference 110 pelleted diet (SAFE, Epinay-sur-Orge, France), ad libitum
- Water: Drinking water filtered by a FG Millipore membrane (0.22 µm), ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: Approximately 18 ± 3 °C
- Humidity: 30-70 %
- Air changes: Approximately 12 cycles/h of filtered, non-recycled air
- Photoperiod: 12 h dark / 12 h light

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): Undiluted test item

Duration of treatment / exposure:

No washing was done.

Observation period (in vivo):

1, 24, 48 and 72 h after administration of the test item.

Number of animals or in vitro replicates:

3 males

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: No

SCORING SYSTEM: According to OECD Guideline 405

TOOL USED TO ASSESS SCORE:
- For the evaluation of corneal opacification (presence or absence, affected area), the eyes were examined under a UV lamp after instillation of one or two drops of 0.5% sodium fluorescein solution (a clear fluorescence is visible in the areas of opacification). This evaluation was performed on Day 2 and repeated thereafter whenever necessary.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Remarks:

mean individual score

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 2

Irritation parameter:

iris score

Basis:

animal #1

Remarks:

mean individual score

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Remarks:

mean individual score

Time point:

other: 24, 48 and 72 h

Score:

0.7

Max. score:

3

Reversibility:

fully reversible within: 72 h

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Remarks:

mean individual score

Time point:

other: 24, 48 and 72 h

Score:

0.7

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 5

Irritation parameter:

cornea opacity score

Basis:

animal #2

Remarks:

mean individual score

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 6

Irritation parameter:

iris score

Basis:

animal #2

Remarks:

mean individual score

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #2

Remarks:

mean individual score

Time point:

other: 24, 48 and 72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 h

Results 8

Irritation parameter:

chemosis score

Basis:

animal #2

Remarks:

mean individual score

Time point:

other: 24, 48 and 72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 9

Irritation parameter:

cornea opacity score

Basis:

animal #3

Remarks:

mean individual score

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 10

Irritation parameter:

iris score

Basis:

animal #3

Remarks:

mean individual score

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Results 11

Irritation parameter:

conjunctivae score

Basis:

animal #3

Remarks:

mean individual score

Time point:

other: 24, 48 and 72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 h

Results 12

Irritation parameter:

chemosis score

Basis:

animal #3

Remarks:

mean individual score

Time point:

other: 24, 48 and 72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 h

Irritant / corrosive response data:

- In all the animals, moderate chemosis and moderate redness of conjunctiva (grade 2) were noted on Day 1, then decreased to slight chemosis and slight redness of conjunctiva (grade 1) on Day 2 which persisted until Day 3 in one of them.
- No other ocular reactions were observed.

Other effects:

None

Any other information on results incl. tables

Table 7.3.2/1: Scores for ocular lesions

Rabbit No.	Descriptionof ocular reactions	Scores
		1 h	24 h	48 h	72 h	Mean#
730	Cornea	0	0	0	0	0.0
	Iris	0	0	0	0	0.0
	Conjunctiva: redness	2	1	1	0	0.7
	Conjunctiva: chemosis	2	1	1	0	0.7
750	Cornea	0	0	0	0	0.0
	Iris	0	0	0	0	0.0
	Conjunctiva: redness	2	1	0	0	0.3
	Conjunctiva: chemosis	2	1	0	0	0.3
749	Cornea	0	0	0	0	0.0
	Iris	0	0	0	0	0.0
	Conjunctiva: redness	2	1	0	0	0.3
	Conjunctiva: chemosis	2	1	0	0	0.3

 

#: Mean scores of 24, 48 and 72 h

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the test conditions, the test item is not classified as irritating to eyes according to the criteria of Annex VI to the Directive 67/548/EEC and CLP Regulation (EC) N° (1272-2008).

Executive summary:

In a GLP-compliant eye irritation study conducted according to the OECD Guideline 405, 3 healthy male rabbits of the New Zealand White strain were instilled 0.1 mL of the undiluted test item in their left eye while the right eye remained untreated and served as control. The eyelids were then gently held together for about one second to avoid any loss of test item. Eyes were examined and scored at 1, 24, 48 and 72 h post instillation for each animal for conjunctival redness, conjunctival chemosis, iris and cornea according to the method of OECD Guideline 405.

No death occured during the study. In all the animals, moderate chemosis and moderate redness of the conjunctiva (grade 2) were noted on Day 1, then decreased to slight chemosis and slight redness of conjunctiva (grade 1) on Day 2 which persisted until Day 3 in one of them. No other ocular reactions were observed. Mean individual scores at 24, 48 and 72 h after exposure for the 3 animals were 0, 0, 0 for cornea score; 0, 0, 0 for iris score; 0.7, 0.3, 0.3 for conjunctivae score and 0.7, 0.3, 0.3 for chemosis score. In this study, test item is not an eye irritant on male rabbits.

Under the test conditions, the test item is not classified as irritating to the eyes according to the criteria of the Annex VI to the Directive 67/548/EEC and to the CLP Regulation (EC) N° (1272-2008).