Oxydiethylene bis(chloroformate)

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Meets national standard methods of that time with acceptable restrictions. As severe eye irritation was noted with a smaller dose than required according to the test guideline it is assumed that a GLP guideline study would not produce a different result.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1968

Report date:

1968

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

application volume 50 µl

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Oxydiethylene bis(chloroformate)

EC Number:

203-430-9

EC Name:

Oxydiethylene bis(chloroformate)

Cas Number:

106-75-2

Molecular formula:

C6H8Cl2O5

IUPAC Name:

oxydiethane-2,1-diyl dichlorocarbonate

Details on test material:

- Name of test material (as cited in study report): Diglycoldichlorkolensäureester
- Physical state: liquid
- Analytical purity: no data
- Other: pH 1; Melting point +4 °C; Boiling point 199 °C

Test animals / tissue source

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Gaukler, offenbach, Germany
- Weight at study initiation: 2.22 kg (male), 2.17 kg (male)

ENVIRONMENTAL CONDITIONS
no data

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.05 ml

Duration of treatment / exposure:

no washing

Observation period (in vivo):

8 days

Number of animals or in vitro replicates:

2

Details on study design:

Administration: into the conjunctival sac
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing

SCORING SYSTEM: descriptive scoring systen comparable to te daize scheme

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: #1+2

Time point:

24/48/72 h

Score:

3

Max. score:

3

Reversibility:

not fully reversible within: 8 days

Results 2

Irritation parameter:

iris score

Basis:

animal: #1+2

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

not fully reversible within: 8 days

Results 3

Irritation parameter:

chemosis score

Basis:

animal: #1+2

Time point:

48 h

Score:

2.8

Max. score:

3

Reversibility:

not fully reversible within: 8 days

Irritant / corrosive response data:

Severe eye irritation, corneal opacity and corrosion of mucous membranes was noted 1 and 24 h after treatment. A thick suppurative layer even at day 8 prevented a full examination of eye reactions, but indicated irreversible changes and eye loss.

Any other information on results incl. tables

Descriptive scores of the raw data have been converted to Draize numerical scores.

Animal	Reading	Opacity	Iritis	Redness	Chemosis	Comment
1	1 h	3	0	1	2
2	1 h	3	0	1	2
1	24 h	3	0	1	3
2	24 h	3	0	1	2
1	48 h	3	0	?	3	suppuration
2	48 h	3	2	?	3	suppuration
1	72 h	3	2	?	3	Suppuration, difficult to evaluate
2	72 h	3	2	?	3	Suppuration, difficult to evaluate
1	8 d	3	2	?	3	Suppuration, difficult to evaluate
2	8 d	3	2	?	2	Suppuration, difficult to evaluate
mean	24 - 72 h	3	1.0	?	2.8

Severe eye irritation, corneal opacity and corrosion of mucous membranes was noted 1 and 24 h after treatment. A thick suppurative layer even at day 8 prevented a full examination of eye reactions, but indicated irreversible changes and eye loss.

Applicant's summary and conclusion

Interpretation of results:

highly irritating

Remarks:

Migrated information

Conclusions:

Severe eye irritation, corneal opacity and corrosion of mucous membranes was noted 1 and 24 h after treatment. A thick suppurative layer on even on day 8 prevented a full examination of eye reactions, but indicated irreversible changes and eye loss.