Registration Dossier
Registration Dossier
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EC number: 203-905-0 | CAS number: 111-76-2
Eye irritation
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:
- 2 000
- 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
- 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
Constituent 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.
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