3,4-dichlorobut-1-ene

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

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1999

Reference 2

Reference Type:

secondary source

Title:

SIDS Initial Assessment Report for 11th SIAM

Author:

OECD SIDS

Year:

2003

Bibliographic source:

UNEP Publications

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

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

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

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: 24, 48, and 72 hours

Score:

0

Max. score:

4

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

other: 24, 48, and 72 hours

Score:

0

Max. score:

4

Results 3

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

Results 4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: 24, 48, and 72 hours

Score:

0

Max. score:

2

Results 5

Irritation parameter:

iris score

Basis:

animal #2

Time point:

other: 24, 48, and 72 hours

Score:

0

Max. score:

2

Results 6

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

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 24, 48, and 72 hours

Score:

0

Max. score:

3

Results 8

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: 24, 48, and 72 hours

Score:

0

Max. score:

3

Results 9

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

other: 24, 48, and 72 hours

Score:

0

Max. score:

3

Results 10

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: 24, 48, and 72 hours

Score:

0

Max. score:

4

Results 11

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

other: 24, 48, and 72 hours

Score:

0

Max. score:

4

Results 12

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.