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EC number: 212-079-0 | CAS number: 760-23-6
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- September 12-16, 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline study. Adopted according to OECD SIDS (public available peer reviewed source). The original source is available and has been reviewed.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Reference Type:
- secondary source
- Title:
- SIDS Initial Assessment Report for 11th SIAM
- Author:
- OECD SIDS
- Year:
- 2 003
- Bibliographic source:
- UNEP Publications
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)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 3,4-dichlorobut-1-ene
- EC Number:
- 212-079-0
- EC Name:
- 3,4-dichlorobut-1-ene
- Cas Number:
- 760-23-6
- Molecular formula:
- C4H6Cl2
- IUPAC Name:
- 3,4-dichlorobut-1-ene
- Details on test material:
- - Name of test material (as cited in study report): 3,4-dichlorobut-1-ene
- Substance type: product
- Physical state: liquid
- Analytical purity: approx. 99%
- Lot/batch No.: PE 482
- Storage condition of test material: room temperature
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: LPT Laboratory of Phamacology and Toxicology KG, D-24601 Löhndorf/Post Wankendorf, Germany
- Age at study initiation: approx-4.5 months
- Weight at study initiation: 2.1-2.3 kg
- Housing: For 8 hours following test substance application, the animals were kept singly in special restrainers which allowed free movement of the head but prevented a complete body turn and wiping of the eyes.
During the acclimatisation period and after the 8-hour period in restainres, the rabbits were kept separately in cages with dimensions of 425 mm x 600 mm x 380 mm.
- Diet (e.g. ad libitum): Altromin 2023, (Altromin GmbH, D-32791 Lage/lippe). The feed was available ad libitum before and after the exposure period.
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 20 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 50 ± 20
- Photoperiod (hrs dark / hrs light): 12/ 12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the left eye, which remained untreated, served as control
- Amount / concentration applied:
- undiluted
Amount applied: 0.1 mL - Duration of treatment / exposure:
- 1 test day and follow-up period of 72 hours
- Observation period (in vivo):
- 1, 24, 48, and 72 hours after administration.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing was performed
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: slit lamp / fluorescein
A dose of 0.1 mL 3,4-dichlorobut-1-ene was administered into the conjunctival sac of the right eye of rabbits after gently pulling the lower lid away from the eyeball. The lid was then gently held together for about one second in order to prevent loss of test material.
The left eye, which remained untreated, served as control.
After the administration the animals were kept separately in special restrainers which allowed free movement of the head but prevented a complete body turn, wiping of the eyes by the paws and excluded irritation of the eyes by excrements and urine.
EXAMINATION OF THE EYES: the eyes were examined ophthalmoscopically with a slit lamp prior to the administration and also 1, 24, 48 and 72 hours after the administration. The eye reactions were observed and registered.
24 hours after administration the eyes were treated additionally with fluorescein and examined.
Based on the most recent guidelines the eye reactions were monitored until the changes observed had completely subsided, however for not more than 21 days after application. Animals that do not reveal any lesions anymore for 24 hours following the first 72 hours of observation were sacrificed.
GENERAL CRITERIA: body weight of all animals was measured at the beginning of the study.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 0.67
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Corneal opacity (grade 1) was observed in animal no. 3 1 to 48 hours after instillation. The fluorescein test performed after 24 hours revealed corneal staining in animal no. 3 (1/4 of the corneal surface). An irritation of the iris (grade 1) was observed in animal no. 3 1 to 48 hours after instillation.
Conjunctival redness (grade 1) was observed in all three animals 1 hour after instillation. There were no systemic intolerance reactions. All the effects were reversible within 72 hours.
Any other information on results incl. tables
Table 1. Acute eye irritation of 3.4 -dichlorobut-1 -ene by instillation into the conjunctival sac of the rabbits
| Rabbit No. | Scoring [h] | Cornea | Iris | Conjuctiva/Redness | Conjuctiva/Chemosis |
| 1 | 1 | 0 | 0 | 0 | 0 |
| 24 | 0 | 0 | 0 | 0 | |
| 48 | 0 | 0 | 0 | 0 | |
| 72 | 0 | 0 | 0 | 0 | |
| Mean (24, 48, 72 h) | 0 | 0 | 0 | 0 | |
| 2 | 1 | 0 | 0 | 0 | 0 |
| 24 | 0 | 0 | 0 | 0 | |
| 48 | 0 | 0 | 0 | 0 | |
| 72 | 0 | 0 | 0 | 0 | |
| Mean (24, 48, 72h) | 0 | 0 | 0 | 0 | |
| 3 | 1 | 1 | 1 | 0 | 0 |
| 24 | 1 | 1 | 0 | 0 | |
| 48 | 1 | 1 | 0 | 0 | |
| 72 | 0 | 0 | 0 | 0 | |
| Mean (24, 48, 72 h) | 0.67 | 0.67 | 0 | 0 |
Based on the test results 3,4-dichlorobut-1-ene is not irritating to eyes, and therefore is not be classified according to DSD and CLP criteria
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: according to DSD and CLP criteria
- Executive summary:
Bayer (1999)
Acute eye irritation was conducted by instillation of the 0.1 mL 3,4-dichlorobut-1-ene into the conjuctival sac of rabbits (OECD guideline 405; EC guideline B.5).
The eyes were examined 1, 24, 48, and 72 hours after the administration with a slit lamp. 24 hours after administration the eyes were treated additionally with fluorescein and examined. The eye reactions were observed and scored with Draize score system.
Corneal opacity (grade 1) was observed in animal no. 3 1 to 48 hours after instillation. The fluorescein test performed after 24 hours revealed corneal staining in animal no. 3 (1/4 of the corneal surface). An irritation of the iris (grade 1) was observed in animal no. 3 1 to 48 hours after instillation.
Conjunctival redness (grade 1) was observed in all three animals 1 hour after instillation. There were no systemic intolerance reactions. All the effects were reversible within 72 hours.
Based on the test results 3,4-dichlorobut-1-ene is not irritating to eyes, and therefore is not be classified according to DSD and CLP criteria.
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