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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:
key study
Study period:
2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study with original study report available.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report date:
2000

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2-butoxyethanol
EC Number:
203-905-0
EC Name:
2-butoxyethanol
Cas Number:
111-76-2
Molecular formula:
C6H14O2
IUPAC Name:
2-butoxyethanol
Details on test material:
- Name of test material (as cited in study report): 2-butoxyethanol
- Physical state: liquid
- Analytical purity: 99.6% (area by gas chromatography)
- Lot/batch No.: source Tanbk B752.
- Date of manufacture 28/2/00
- Storage condition of test material: room temperature under nitrogen.
- Internal reference number 00/0182-1

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann, Borchen
- Strain: Hsd POC NZW (SPF)
- Age at study initiation: Young adults
- Weight at start: 3.07 - 3.52kg
- Housing: singly, no bedding
- Diet (ad libitum): Klibe-Labordiaet (Frovimi Klibe SA, Switzerland), 130g/day
- Water (ad libitum): tap
- Acclimation period: 1 week
- Sex: female.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 13/3/00 To: 3/4/00

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1ml
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
21 days. Observations at 1, 24, 48, 72 hours then 7, 14, 21 days
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes
- Time after start of exposure: Immediately prior to 24 hour reading

SCORING SYSTEM: According to OECD 405 guideline (adopted Feb. 24, 1987) and EEC L 383A, B.5 (Dec. 29, 1992).

TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein: no data.

Prior to treatment, both eyes of the animals were examined for signs of pre-existing irritation, reaction or abnormality which would prevent it from being used on the study. Following single application of the test substance to the conjunctival sac of the right eyelid, the substance was washed out with tap water about 24 h after application (before 24 h reading) and the eyes were examined for signs indicative of irritation after 1, 24, 48 and 72 hours, and further after 7, 14 and 21 days.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: average of 24, 48, 72 hr readings
Score:
0.89
Max. score:
4
Reversibility:
fully reversible within: 21 days
Remarks on result:
other: animal #2 last to show symptoms
Irritation parameter:
iris score
Basis:
mean
Time point:
other: average of 24, 48, 72 hr readings
Score:
0.56
Max. score:
2
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: animals #1 and #2 last to show symptoms
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: average of 24, 48, 72 hr readings
Score:
2.6
Max. score:
3
Reversibility:
fully reversible within: 21 days
Remarks on result:
other: animals #2 and #3 last to show symptoms
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: average of 24, 48, 72 hr readings
Score:
1.8
Max. score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: animal #1 last to show symptoms
Irritant / corrosive response data:
see above and table in remarks on results below.
Other effects:
Blood discharge in animals 2 and 3 at timepoints 24, 48, 72 hours, disappeared by day 7. Suppuration in animals 1 and 2 at time points 8, 72 hours, disappeared by day 7.

Any other information on results incl. tables

Individual animal results:

Animal

Time (hrs)

Opacity

Iritis

Redness

Chemosis

1

24

1

0

2

2

48*

1

0

2

2

72*

1

1

3

2

14 days

0

0

0

0

2

24**

0

1

3

2

48***

1

1

3

2

72***

1

1

3

2

21 days*

0

0

0

0

3

24**

1

1

3

2

48**

1

0

2

1

72**

1

0

2

1

21 days

0

0

0

0

Additional findings:

* suppuration

** discharge of blood

*** suppuration and discharge of blood

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance is irritating to the eye and recovery of lesions is slow but takes place within 21 days when washing is carried out 24 hours after initial exposure.
Executive summary:

In a GLP study performed according to OECD guideline 405, rabbits were instilled with 2 -butoxyethanol. Animals were observed for 21 days. Eye washing was performed about 24 hours after treatmnent, before the 24 hour reading. This practice is optional in the guideline but is considered more representative of human exposure, where lachrymation will create a washing action. One animal exhibited a slight corneal opacity reversible in 21 days. Signs of a slight iris injury was described, reversible in 7 days. A medium to severe irritation of the conjunctivae was also observed and was reversible in 21 days. According to criteria for assessment of ocular lesions, 2 -butoxyethanol can be considered as an eye irritant.

Synopsis: irritant under DSD and a category 2 eye irritant under the EU GHS regulation, based on the severity of the conjunctival effects.