2-(2-butoxyethoxy)ethanol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Sufficient basic data given to be able to judge as reliable. Only 2 animals used dosing volume only 50ul.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1956

Report date:

1956

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

BASF-Test: One drop (50 microliter) of the test substance was applied to the conjunctival sac of one eye in 2 animals. The non-treated adjacent eye served as control.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-(2-butoxyethoxy)ethanol

EC Number:

203-961-6

EC Name:

2-(2-butoxyethoxy)ethanol

Cas Number:

112-34-5

Molecular formula:

C8H18O3

IUPAC Name:

2-(2-butoxyethoxy)ethanol

Details on test material:

- Name of test material (as cited in study report): Diaethylenglykolmonobutylaether = Butylpolyglykol; Butyldiglykol
- Physical state: clear liquid
- Analytical purity: 98%
- Impurities (identity and concentrations): 2% Triethylene glycol butyl ether

Test animals / tissue source

Species:

rabbit

Strain:

Vienna White

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 microliter (1 drop)

Duration of treatment / exposure:

see observation period; no washing out conducted

Observation period (in vivo):

scoring after 10 min, 1, 3 and 48 h

Number of animals or in vitro replicates:

2

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 48 hour

Score:

0

Max. score:

4

Remarks on result:

other: no corneal opacity detected

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 48 hour

Score:

0

Max. score:

2

Remarks on result:

other: no iritis detected

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 48 hour

Score:

0

Max. score:

3

Remarks on result:

other: conjunctivae redness until 3 h after application; 48 h after application: redness no longer detected

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 48 hour

Score:

0

Max. score:

4

Remarks on result:

other: chemosis until 3 h after application; 48 h after application: chemosis no longer detected

Any other information on results incl. tables

The original BASF grading was converted into the numerical grading according to the OECD Draize system. Findings are shown for two rabbits: rabbit 3465 / rabbit 3463.

Findings after	erythema	edema	symptoms
10 min	1/1	1/1	secretion/secretion
1 hour	1/1	1/1	secretion/secretion
3 hours	1/1	1/1	secretion/no findings
48 hours	0/0	0/0	no findings/no findings

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

Diaethylenglykolmonobutylaether was not irritating to the eyes.

Executive summary:

In an old but reliable acute eye irritation study, 2-(2-butoxyethoxy)ethanol was instilled in the eyes of two rabbits and observations reported 10 minutes, 1, 3 and 48 hours after dosing. No iritis or corneal effects were observed. Only mild conjunctival erythema and chemosis were observed and these effects had disappeared by the 48 hour observation. On this basis, the substance does not appear to have significant eye irritation potential and would not warrant classification. However, it should be noted that the volume of substance instilled was only 50ul.