Registration Dossier
Registration Dossier
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EC number: 230-991-7 | CAS number: 7397-62-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1988-JAN-26 through 1988-FEB-02
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Butyl glycollate
- EC Number:
- 230-991-7
- EC Name:
- Butyl glycollate
- Cas Number:
- 7397-62-8
- Molecular formula:
- C6H12O3
- IUPAC Name:
- butyl glycolate
- Reference substance name:
- Polysolvan O
- IUPAC Name:
- Polysolvan O
- Reference substance name:
- Glycolic acid-n-butyl ester
- IUPAC Name:
- Glycolic acid-n-butyl ester
- Details on test material:
- - Name of test material (as cited in study report): Polysolvan O (butyl glycollate)
- Physical state: liquid
- Analytical purity: 96%
- Impurities (identity and concentrations): chloro acetic acid n-butyl ester (0.1%), butoxy acetic acid n-butyl ester (3.2%), butanol (<0.1
- Purity test date: certificate No. 115238 dated 04.01.1988
- Lot/batch No.: batch from 29.12.1987
- Storage condition of test material: in the dark at 22°C
Constituent 1
Constituent 2
Constituent 3
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AK, Kastengrund, Germany
- Age at study initiation: about 3 – 5 months
- Weight at study initiation: 2.2 – 2.9 kg
- Housing: single in cages
- Diet (e.g. ad libitum): standard chow (Altromin 2123 Haltungsdiaet Kaninchen, Altromin GmbH, Lage/Lippe, Germany) ad libitum
- Water (e.g. ad libitum): tap water ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Humidity (%): 50 ± 20%
- Photoperiod (hrs dark / hrs light): 12 Hrs light/12 hrs dark
IN-LIFE DATES: From: 1988-Jan-26 to 1988-Feb-02
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): neat
VEHICLE
- none - Duration of treatment / exposure:
- treated eyes were washed after 24 hours.
- Observation period (in vivo):
- up to 7 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): treated eyes were washed 24 h after installation of fluorescent dye and prior to eye examination
- Time after start of exposure: 24 h
SCORING SYSTEM: according to the OECD 405 procedure
TOOL USED TO ASSESS SCORE: Fluorescein under UV light
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.8
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.9
- Max. score:
- 1
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.6
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.6
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Irritant / corrosive response data:
- Overall irritation score (24, 48 and 72 h):
Conjunctival erythema: 2.6 (mean of all animals)
Conjunctival chemosis: 1.6 (mean of all animals)
Iritis: 0.9 (mean of all animals)
Corneal opacity: 1.8 (mean of all animals) - Other effects:
- Not recorded
Any other information on results incl. tables
Individual results:
Time after instillation |
1 h |
24 h |
48 h |
72 h |
7 d |
||||||||||
Animal No. |
1 |
2 |
3 |
1 |
2 |
3 |
1 |
2 |
3 |
1 |
2 |
3 |
1 |
2 |
3 |
Chemosis |
4 |
3 |
4 |
3 |
2 |
1 |
1 |
2 |
1 |
1 |
2 |
1 |
0 |
1 |
0 |
Conjunctivae score |
1 |
2 |
2 |
2 |
3 |
3 |
3 |
3 |
2 |
1 |
3 |
3 |
0 |
2 |
0 |
Iris score |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
0 |
1 |
1 |
0 |
1 |
0 |
Cornea score |
1 |
2 |
1 |
2 |
2 |
2 |
2 |
2 |
2 |
1 |
2 |
1 |
0 |
3 |
0 |
Fluorescine test |
Not done |
4 |
4 |
4 |
Not done |
1 |
4 |
2 |
0 |
2 |
0 |
||||
In addition, eye discharge ranging from colorless – white, discolored conjunctivae including bleeding and vascularisation of the cornea of different degree was observed in individual animals at different time points.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Polysolvan O (butyl glycollate) was highly irritating to the eyes of the rabbits and has to be classified as Eye Dam. 1 (H318: Causes serious eye damage) according to Regulation (EC) No 1272/2008.
- Executive summary:
In a primary eye irritation study, 0.1 mL of the unchanged Polysolvan O (butyl glycollate, 96%) was instilled into the conjunctival sac of the left eye of three young adult New Zealand White rabbits for 24 hours. The right eyes served as controls. After 24 hours of exposure, the eyes were washed out with physiological saline solution prior to scoring. The animals were observed for up to 7 days and the readings were performed at 1, 24, 48, 72 hours and 7 days. Irritation was scored according to the scoring scheme of Draize as recommended procedure by OECD guideline 405.
Various, partly severe signs of ocular irritation were noted in all animals, some of them were not reversible within the 7 day observation period. The mean score for conjunctival erythema was 2.6, conjunctival chemosis was 1.6, iritis was 0.9 and corneal opacity was 1.8. In addition, eye discharge ranging from colorless – white, discolored conjunctivae including bleeding and vascularisation of the cornea of different degree was observed in individual animals at different time points. The symptoms were not completely subsided after 7 days.
Conclusion
Polysolvan O (butyl glycollate, 96%) was examined for its primary eye irritating potential in a valid study conducted according to OECD test guideline No. 405 and under GLP conditions. Polysolvan O (butyl glycollate) was highly irritating to the eyes of the rabbits.
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