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Toxicological information

Eye irritation

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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

Reference
Name:
Unnamed
Type:
Constituent
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

Resultsopen allclose all
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
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 48 hour
Score:
0
Max. score:
2
Remarks on result:
other: no iritis detected
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
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:
Migrated information 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.