1,2-dimethoxyethane

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:

other: Methods applied similar to OECD405, report not detailed, no individual data

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

no recovery period, scoring according to FDA

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: FDA Guideline, Register 38 No. 187, 27.09.1973, p 27019

GLP compliance:

no

Remarks:

study performed before GLP guidelines

Test material

Test material information

Constituent 1

Reference substance name:

Monoethylenglykoldimethylether

IUPAC Name:

Monoethylenglykoldimethylether

Constituent 2

Reference substance name:

1,2-dimethoxyethane

EC Number:

203-794-9

EC Name:

1,2-dimethoxyethane

Cas Number:

110-71-4

Molecular formula:

C4H10O2

IUPAC Name:

1,2-dimethoxyethane

Details on test material:

- Name of test material (as cited in study report): Monoethylenglykoldimethylether
- Analytical purity: not stated
- physical state: clear colourless liquid

Test animals / tissue source

Species:

rabbit

Strain:

other: New Zealand

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG own breed
- Weight at study initiation: 1,9-2,7 kg
- Age at study initiation: no data
- Diet: ERKA 8300 (Futtermittelwerk Robert Koch oHG, Hamm/Westf.) ad libitum
- Water ad libitum
- Acclimatization period: no data

ENVIRONMENTAL CONDITIONS
- Housing: single cages

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0,1 ml

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

1 hour post application
7 hours post application
24 hours post application
48 hours post application
72 hours post application

Number of animals or in vitro replicates:

6 rabbits

Details on study design:

The eyes were examined 1, 7, 24, 48 and 72 hours after application of the test substance.
24 hours after treatment the eyes were washed out with physological saline.
At 48 and 72 hours the eyes were also examined after instillation of one drop of 0.01 % fluorescein-sodium solution.

SCORING SYSTEM:

A. CORNEA
Degree of opacity (most dense area used)
No opacity ...................................................................................................................0
Scattered or diffuse areas, details of iris clearly visible........................................1
Easily discernible translucent areas, details of iris slightly obscured................2
Opalescent areas, no details of iris visible , size of pupil barely discernible ....3
Opaque, iris invisible, ulzeration ..............................................................................4

B. Affected area
1 = punctiform up to 1/4 but not 0
2 = more than 1/4 up to 1/2
3 = more than 1/2 up to 3/4
4 = more than 3/4 up t o 4/4

a = A x B x 5 (max 80)

IRIS
Normal ......................................................................................................................... 0
Folds above normal , congestion, swelling, circumcorneal injection (any of all of these or combination of any thereof); iris still reacting to light
(sluggish reaction is positive) ......................... .........................................................1
No reaction to light, haemorrhage, gross destruction (any or all of these) ......2

b = Value x 5 (max. 10)

CONJUNCTIVAE

A. Redness
Blood vessels normal...............................................................................................................0
Blood vessels definitely injected above normal ................................................................. 1
More diffuse, deeper crimson red, individual blood vessels not easily discernible .....2
Diffuse beefy red......................................................................................................................3

B. Chemosi s (refers to palpebral and bulbar conjunctivae)
No swelling .........................................................................................0
Any swelling above normal (includes nictitating membran) ..... 1
Obvious swelling with partial eversion of l i d s ...........................2
Swelling with lids about half closed ................................................3
Swelling with lids half closed to completely closed.......................4

C. Secretion
No secretion......................................................................................................................0
Any secretion above normal...........................................................................................1
Secretion with wetting of palpebra and hair close to palpebra.................................2
Secretion with wetting of palpebra, hair and considerable area around eyes........3

c = (A+B+C) x 2 (max. 20)

For each animal the ratings for cornea (a), iris (b) and conjunctivae (c) were added for the respective time of observation. For each time of observation the mean value was calculated for all animals. The highest determined irritation score for any time of observation was used for classification according following evaluation classes:

0-10..........non irritant
11-25.......slightly irritant
26-56.......moderately irritant
57-110.....severely irritant

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 1 h

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 1 h

Results 2

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 7 h

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 7 h

Results 3

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24 h

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 24 h

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

48 h

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 48 h

Results 5

Irritation parameter:

chemosis score

Basis:

mean

Time point:

72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 6

Irritation parameter:

maximum mean total score (MMTS)

Basis:

mean

Remarks:

all animals

Time point:

other: 1 hour

Score:

29

Max. score:

110

Reversibility:

not specified

Results 7

Irritation parameter:

maximum mean total score (MMTS)

Basis:

mean

Remarks:

all animals

Time point:

other: 7 hours

Score:

24

Max. score:

110

Reversibility:

not specified

Results 8

Irritation parameter:

maximum mean total score (MMTS)

Basis:

mean

Remarks:

all animals

Time point:

24 h

Score:

26

Max. score:

110

Reversibility:

not specified

Results 9

Irritation parameter:

maximum mean total score (MMTS)

Basis:

mean

Remarks:

all animals

Time point:

48 h

Score:

10

Max. score:

110

Reversibility:

not specified

Results 10

Irritation parameter:

maximum mean total score (MMTS)

Basis:

mean

Remarks:

all animals

Time point:

72 h

Score:

3

Max. score:

110

Reversibility:

not fully reversible within: 72 h

Results 11

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

all animals

Time point:

other: 1 hour

Score:

15.8

Max. score:

80

Reversibility:

not fully reversible within: 1 hour

Results 12

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

all animals

Time point:

other: 7 hours

Score:

9.2

Max. score:

80

Reversibility:

not fully reversible within: 7 hours

Results 13

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

all animals

Time point:

24 h

Score:

11.7

Max. score:

80

Reversibility:

not fully reversible within: 24 hours

Results 14

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

all animals

Time point:

48 h

Score:

3.3

Max. score:

80

Reversibility:

not fully reversible within: 48 hours

Results 15

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

all animals

Time point:

72 h

Score:

0

Max. score:

80

Reversibility:

fully reversible within: 72 hours

Results 16

Irritation parameter:

iris score

Basis:

mean

Remarks:

all animals

Time point:

other: 1 hour

Score:

0

Max. score:

10

Reversibility:

other: no abnormality detected

Results 17

Irritation parameter:

iris score

Basis:

mean

Remarks:

all animals

Time point:

other: 7 hours

Score:

1.7

Max. score:

10

Reversibility:

not fully reversible within: 7 hours

Results 18

Irritation parameter:

iris score

Basis:

mean

Remarks:

all animals

Time point:

24 h

Score:

2.5

Max. score:

10

Reversibility:

not fully reversible within: 24 hours

Results 19

Irritation parameter:

iris score

Basis:

mean

Remarks:

all animals

Time point:

48 h

Score:

0

Max. score:

10

Reversibility:

not fully reversible within: 48 hours

Results 20

Irritation parameter:

iris score

Basis:

mean

Remarks:

all animals

Time point:

72 h

Score:

0

Max. score:

10

Reversibility:

fully reversible within: 48 hours

Results 21

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

all animals

Time point:

other: 1 hour

Score:

13

Max. score:

20

Reversibility:

not fully reversible within: 1 hour

Results 22

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

all animals

Time point:

other: 7 hours

Score:

13

Max. score:

20

Reversibility:

not fully reversible within: 7 hours

Results 23

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

all animals

Time point:

24 h

Score:

12

Max. score:

20

Reversibility:

not fully reversible within: 24 hours

Results 24

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

all animals

Time point:

48 h

Score:

6.3

Max. score:

20

Reversibility:

not fully reversible within: 48 hours

Results 25

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

all animals

Time point:

72 h

Score:

3.3

Max. score:

20

Reversibility:

not fully reversible within: 72 h

Any other information on results incl. tables

Detailed results:

Hour	Animal No.	Illumination	Cornea			Iris		Conjunctiva				a+b+c (max.110)	mean
			A Opacity	B Area	a = AxBx5 (max.80)	Value	Valuex5 (max.10)	A Redness	B Chemosis	C Discharge	c = A+B+Cx2
1	I		1	4	20	0	0	1	3	3	14	34	29
	II		1	2	10	0	0	2	2	3	14	24
	III		1	4	20	0	0	2	2	2	12	32
	IV		1	1	5	0	0	1	1	2	8	13
	V		1	4	20	0	0	2	2	3	14	34
	VI		1	4	20	0	0	2	3	3	16	36
7	I		1	4	20	0	0	3	2	3	13	36	24
	II		1	1	5	1	5	2	1	3	12	22
	III		1	4	20	0	0	2	1	2	10	30
	IV		0	0	0	0	0	2	1	1	8	8
	V		1	1	5	0	0	3	1	3	14	19
	VI		1	1	5	1	5	3	3	3	18	28
24	I		1	4	20	1	5	3	2	3	16	41	26
	II		1	1	5	0	0	2	0	0	4	9
	III		0	0	0	0	0	3	2	2	14	14
	IV		1	1	5	0	0	2	0	2	8	13
	V		1	4	20	1	5	3	1	2	12	37
	VI		1	4	20	1	5	3	3	3	18	43
48	I	NAD	1	4	20	0	0	2	1	1	8	28	10
	II	NAD	0	0	0	0	0	1	0	0	2	2
	III	NAD	0	0	0	0	0	1	1	0	4	4
	IV	NAD	0	0	0	0	0	2	1	0	6	6
	V	NAD	0	0	0	0	0	2	1	1	8	8
	VI	NAD	0	0	0	0	0	2	2	2	12	12
72	I	NAD	0	0	0	0	0	1	0	0	2	2	3
	II	NAD	0	0	0	0	0	1	0	0	2	2
	III	NAD	0	0	0	0	0	1	1	1	6	6
	IV	NAD	0	0	0	0	0	1	0	0	2	2
	V	NAD	0	0	0	0	0	1	0	0	2	2
	VI	NAD	0	0	0	0	0	2	1	0	6	6

 

NAD = no abnormality detected

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

With reference the reported scores and the reversibility of the observed effects Ethylene glycol dimethyl ether does not have to be classified as irritant to the eyes according to the criteria laid down in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).
.

Executive summary:

Ethylene glycol dimethyl ether was tested for its eye irritant properties in 6 New Zealand White rabbits.The study was performed according to OECD Guideline 405. The only deviation was the absence of the recovery period of 14 days. Effects on conjunctivae (redness and swelling) were observed in all animals one hour after application. These signs decreased significantly within 72 hours and full reversibility is assumed occur after 14 days recovery.

 

With reference the reported scores and the reversibility of the observed effects Ethylene glycol dimethyl ether does not have to be classified as irritant to the eyes according to the criteria laid down in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).

.