2-chloro-1,1-diethoxyethane

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

For the assessment of ethane, 2-chloro-1,1-diethoxy (chloroacetaldehyde-diethylacetal) a read-across approach to the structural analogue ethane, 2-chloro-1,1-dimethoxy (chloroacetaldehyde-dimethylacetal) has been considered appropriate as both substances have similar physical-chemical properties. The dimethylacetal can be considered as a worst-case-approach as it has a lower molecular weight compared with the diethylacetal. The dimethylacetal has a lower pH in water, a higher water solubility, a higher vapour pressure, boiling point and flammability. Stability and hydrolysis are also comparable with ethane, 2-chloro-1,1-diethoxy resp. ethane, 2-chloro-1,1-dimethoxy reacting with acids releasing chloroacetaldehyde and ethanol resp. methanol. Here also the release of methanol can be - compared to the release of ethanol - considered as a worst-case approach.
Therefore the read-across from the diethoxy-compound to the dimethoxy-compound is considered appropriate.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: OECD Guideline Study

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Species:

rabbit

Strain:

Californian

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Schweizer Hof Untergröningen, Dr. Zimmermann
- Housing: individually in suspended stainless steel cages (2450 cm²)
- Diet: Raiffeisen Alleinfuttermittel 52/P for rabbits; once daily ca. 180g
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22
- Humidity (%): 45-70
- Photoperiod (hrs dark / hrs light): 12/12

Vehicle:

physiological saline

Controls:

yes

Amount / concentration applied:

TEST MATERIAL: Amount applied: 0.1ml per rabbit on the right eye
VEHICLE: physiological saline

Duration of treatment / exposure:

24h

Observation period (in vivo):

14 days

Number of animals or in vitro replicates:

3

Details on study design:

TOOL USED TO ASSESS SCORE: fluorescein

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24h

Score:

0

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 14d

Score:

0

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 1h

Score:

1

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24h

Score:

1.33

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 48h

Score:

1.33

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 72h

Score:

1

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 4th day

Score:

0.33

Reversibility:

fully reversible

Other effects:

body weight gain of all 3 animals

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Acute systematic toxic symptoms could not be observed on any of the animals.

Executive summary:

According to OECD Guideline 405 Chloroacetaldehyde dimethylacetal was tested in 3 male albino rabbits.

After an acclimation period of 5 days 0.1 ml Chloroacetaldehyde dimethylacetal was applied only once on the rabbits’ right eye.

Acute systematic toxic symptoms could not be observed on any of the animals.

None of the animals died during the observation period.

Up from the 6^thday macroscopic changes could be observed on any of the animals.

The left eye acted as the control eye and was observed during the same observation time as the right eye. No signs were noticed.

The animals showed body weight gain during the observation period.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1991

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Ethane, 2-Chloro-1,1-Dimethoxy-

IUPAC Name:

Ethane, 2-Chloro-1,1-Dimethoxy-

Constituent 2

Reference substance name:

97-97-02

IUPAC Name:

97-97-02

Constituent 3

Reference substance name:

2-chloro-1,1-dimethoxyethane

EC Number:

202-624-0

EC Name:

2-chloro-1,1-dimethoxyethane

Cas Number:

97-97-2

Molecular formula:

C4H9ClO2

IUPAC Name:

2-chloro-1,1-dimethoxyethane

Test material form:

other: colourless liquid

Details on test material:

- Name of test material (as cited in study report): Chloroacetaldehyde dimethylacetal
- Physical state: colourless liquid
- Storage condition of test material: room temperature
- Container: brown glass bottle x2

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24 h

Score:

ca. 0

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

14 d

Score:

ca. 0

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 4th day

Score:

ca. 0.33

Reversibility:

fully reversible