Ethanol, 2-ethoxy-, manufacture of, by-products from

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Study period:

11 Feb 1974 - 18 Feb 1974

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable study report which meets basic scientific principles. Some data missing for one animal.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

, 2 animals only

Principles of method if other than guideline:

Method: BASF-Test. The test substance were applied to the conjunctival sac of one eye in 2 animals. The animals were observed after 10 min, 1 and 3h on the day of treatment and up to 8 days afterwards. Findings were recorded daily. The eyes were not washed out after 24 hour. The report describes findings after 1 and 24 hours and at the end of the observation period. For final evaluation, the findings after 48 and 72 hours from the raw data were taken into account.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-(2-(2-methoxyethoxy)ethoxy)ethanol

EC Number:

203-962-1

EC Name:

2-(2-(2-methoxyethoxy)ethoxy)ethanol

Cas Number:

112-35-6

Molecular formula:

C7H16O4

IUPAC Name:

2-[2-(2-methoxyethoxy)ethoxy]ethanol

Details on test material:

- Name of test material (as cited in study report): Methyltriglykol. Test substance No. 88/289
- Physical state: liquid
- Analytical purity: ca. 95%

Test animals / tissue source

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Gaukler
- Weight at study initiation: 2.94 kg (mean)

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: The adjacent eye served as saline-control.

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.05 ml

Duration of treatment / exposure:

8 days

Observation period (in vivo):

8 days

Number of animals or in vitro replicates:

2

Details on study design:

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

SCORING SYSTEM: The original BASF grading was converted into the numerical grading according to the OECD Draize system.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 1h

Score:

1

Max. score:

3

Reversibility:

fully reversible

Results 2

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 24h

Score:

0

Max. score:

3

Reversibility:

fully reversible

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: 1h

Score:

1

Max. score:

3

Reversibility:

fully reversible

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: 24h

Score:

1

Max. score:

3

Reversibility:

fully reversible

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: 8 days

Score:

0

Max. score:

3

Reversibility:

fully reversible

Irritant / corrosive response data:

No response for any parameter apart from conjunctiva.

Any other information on results incl. tables

Findings animal 1:

Time	erythema	chemosis	opacity	iritis
1h	1	0	0	0
24h	0	0	0	0
48h	0	0	0	0
72h	0	0	0	0
8d	0	0	0	0

Findings animal2

Time	erythema	chemosis	opacity	iritis
1h	1	0	0	0
24h	1	0	0	0
48h	-	-	-	-
72h	-	-	-	-
8d	0	0	0	0

"-" The original readings for animal 2 for timepoints 48h and 72h are missing.

Mean values over 24, 48 and 72 hours:

-------------------------------------

Animal 1: Erythema: 0, Chemosis: 0, Opacity: 0, Iritis: 0

Animal 2: data not available. Information for 24 hrs only: Erythema: 1, Chemosis: 0, Opacity: 0, Iritis: 0

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Executive summary:

In an eye irritation study which broadly followed the OECD guideline but for which only comprehensive data was available for a single animals, 2 -(2 -(2 -methoxyethoxy)ethoxy)ethanol was instilled in the eyes of 2 rabbits, which were then observed for up to 8 days. No washout was used. Minimal effects were observed. No chemosis, corneal opacity or iritis was seen and only mild conjunctival odema which had certainly disappeared within 8 days and possibly sooner. On the basis of this information, this substance has a low potential for eye irritancy and does not warrant classification as an eye irritant.