Reaction mass of (Z)-3-(9-octadecenyloxy)propane-1,2-diol and alpha-(Z)-octadec-9-en-1-yl-omega-hydroxy-di[oxy[(hydroxymethyl)-1,2-ethanediyl]] and alpha-(Z)-octadec-9-en-1-yl-omega-hydroxy-tri[oxy[(hydroxymethyl)-1,2-ethanediyl]]

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

16 -24 October 1995

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: non-GLP study conducted in compliance with OECD Guideline 405 with deviations: age at study initiation and individual animal weights not reported; environmental conditions 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:

1996

Report date:

1996

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

age at study initiation and individual animal weights not reported; environmental conditions not reported

Principles of method if other than guideline:

Not applicable

GLP compliance:

no

Remarks:

COFRAC accreditation on technical ability

Test material

Test material information

Constituent 1

Reference substance name:

Reference substance 001

Cas Number:

9022-76-8

Details on test material:

- Name of test material (as cited in study report): Chimexane NB
- Physical state: Yellow viscous liquid
- Lot/batch No.: M 752
- Analytical purity: 98%
- Date received: 09 October 1995
- Storage condition of test material: Room temperature, away from the light and heat

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: elevage BERTHO, Yffiniac, France
- Weight at study initiation: 2.3 kg (mean)
- Housing: Animals were housed individually on floor grid.
- Diet: Complete pelleted rabbit maintenance diet Energie H326 (COFNA, Tours, France), ad libitum
- Acclimation period: 5 days

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):

9 days

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:
- Ocular reactions were performed with a U. V. and white magnification light. After recording the observations at 24 h, the eyes of all rabbits were examined with the aid of fluorescein.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Remarks:

mean individual score

Time point:

24/48/72 h

Score:

1.3

Max. score:

4

Reversibility:

fully reversible within: 5 days

Results 2

Irritation parameter:

iris score

Basis:

animal #1

Remarks:

mean individual score

Time point:

24/48/72 h

Score:

0.3

Max. score:

2

Reversibility:

fully reversible within: 48 h

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Remarks:

mean individual score

Time point:

24/48/72 h

Score:

3

Max. score:

3

Reversibility:

fully reversible within: 9 days

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Remarks:

mean individual score

Time point:

24/48/72 h

Score:

1.7

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 5

Irritation parameter:

cornea opacity score

Basis:

animal #2

Remarks:

mean individual score

Time point:

24/48/72 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:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible within: 24 h

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #2

Remarks:

mean individual score

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 8

Irritation parameter:

chemosis score

Basis:

animal #2

Remarks:

mean individual score

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 5 days

Results 9

Irritation parameter:

cornea opacity score

Basis:

animal #3

Remarks:

mean individual score

Time point:

24/48/72 h

Score:

0.7

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 10

Irritation parameter:

iris score

Basis:

animal #3

Remarks:

mean individual score

Time point:

24/48/72 h

Score:

0.3

Max. score:

2

Reversibility:

fully reversible within: 48 h

Results 11

Irritation parameter:

conjunctivae score

Basis:

animal #3

Remarks:

mean individual score

Time point:

24/48/72 h

Score:

2.3

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 12

Irritation parameter:

chemosis score

Basis:

animal #3

Remarks:

mean individual score

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritant / corrosive response data:

- One hour after instillation of the substance, redness of the palpebral and bulbar conjunctivae with abundant discharge and slight chemosis were observed.
- Slight iris congestion observed in three rabbits disappeared in less than 48 h.
- 24 h later, conjunctival reactions (redness and chemosis) increased slightly and a partial corneal opacity was noticed in two rabbits, it disappeared in less than 4 days.
- Complete reversibility occurred within about a week in all animals.

Other effects:

No data

Any other information on results incl. tables

Table 7.3.2/1: Results of eye irritation

Animal no.	4582						4583						4584
	Conjunctiva			Iris	Cornea		Conjunctiva			Iris	Cornea		Conjunctiva			Iris	Cornea
	A	B	C	D	E	F	A	B	C	D	E	F	A	B	C	D	E	F
D1 (1 h)	1	2	2	1	0	0	1	3	2	1	0	0	1	3	2	1	0	0
24 h	3	1	3	1	2	1	1	1	2	0	0	0	1	1	3	1	1	1
48 h	1	1	3	0	1	1	1	1	2	0	0	0	1	1	2	0	1	1
72 h	1	1	3	0	1	1	1	0	2	0	0	0	1	1	2	0	0	0
M	1.7	1.0	3.0	0.3	1.3	1.0	1.0	0.7	2.0	0.0	0.0	0.0	1.0	1.0	2.3	0.3	0.7	0.7
D5	1	0	2	0	0	0	0	0	1	0	0	0	1	0	1	0	0	0
D6	1	0	2	0	0	0	0	0	1	0	0	0	1	0	1	0	0	0
D7	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
D8	0	0	1	0	0	0	-	-	-	-	-	-	-	-	-	-	-	-
D9	0	0	0	0	0	0	-	-	-	-	-	-	-	-	-	-	-	-

 

A: Chemosis; B: Discharge; C: Redness; D: Iris lesion; E: Opacity; F: Opacity area; M: Mean

Applicant's summary and conclusion

Interpretation of results:

Category 2A (irritating to eyes)

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the test conditions, Chimexane NB is classified as “R36 irritating to eyes”, according to the Annex VI of the Directive 67/548/EEC and "irritating to eyes (Category 2)" according to the Regulation (EC) N° 1272-2008 (CLP).

Executive summary:

In an eye irritation study conducted according to the OECD Guideline 405, 3 healthy male rabbits of the New Zealand White strain were exposed to 0.1 mL of undiluted test item Chimexane NB in their right eye while the left 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. At 24 h after treatment, fluorescein solution was instilled into the eyes and they were examined under UV-lamp to detect possible corneal damage. The eyes were examined and the changes were observed at 1, 24, 48 and 72 h and up to Day 9 after treatment and graded according to the method of OECD Guideline 405.

One hour after instillation of the substance, redness of the palpebral and bulbar conjunctivae with abundant discharge and slight chemosis were observed. Slight iris congestion observed in three rabbits disappeared in less than 48 h. 24 h later, conjunctival reactions (redness and chemosis) increased slightly and a partial corneal opacity was noticed in two rabbits, it disappeared in less than 4 days. Complete reversibility occurred within about a week in all animals. Mean individual scores at 24, 48 and 72 h after exposure for the 3 animals were 1.3, 0.0, 0.7 for cornea score; 0.3, 0.0, 0.3 for iris score; 3.0, 2.0, 2.3 for conjunctivae score and 1.7, 1.0, 1.0 for chemosis score. In this study, Chimexane NB is an eye irritant on male rabbits.

Under the test conditions, Chimexane NB is classified as “R36 irritating to eyes”, according to the Annex VI of the Directive 67/548/EEC and ‘irritating to eyes (Category 2)’ according to the Regulation (EC) N° 1272-2008 (CLP).