Mixture of acrylic acid 4-[(chlorocarbonyl)oxy]butyl ester and 3-chloropropanoic acid 4-[(chlorocarbonyl)oxy]butyl ester

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP and guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Remarks:

testing lab.

Test material

Test material information

Constituent 1

Reference substance name:

Acryloxibutylchlorformiat

IUPAC Name:

Acryloxibutylchlorformiat

Details on test material:

- Name of the test substance used in the study report: Acryloxibutylchlorformiat
- Purity: ca. 75%

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

A young adult female animal with a body weight of 3.81 kg was used.
Cage (type: stainless steel wire mesh cages with grating, floor area 3000 cm2). The animal was identified via ear tattoo.
The animal was housed in fully air-conditioned rooms with a room temperature of 20 - 24°C and a relative humidity of 30 - 70%. The day/night rhythm was 12 h light and 12 h dark.
The animal was offered a standardized animal laboratory diet (about 130 g/day) as well as tap water (about 250 ml/day).
Acclimatization period: at least one week

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye

Amount / concentration applied:

0.1 ml

Duration of treatment / exposure:

24 h

Observation period (in vivo):

21 d

Number of animals or in vitro replicates:

1

Details on study design:

Both eyes of the animal were examined before instillation of thetes substance for signs of pre-existing irritation, reaction or abnormality which would prevent it from being used on the study.
Weight determination: shortly before instillation
Single instillation into the conjunctival sac of the right eyelid; the test substance was not washed out.
Readings: 1 h, 24 h, 48 h, 72 h, 8 d, 15 d, 21 d
A check for general observations and mortality was made twice each working day and once on weekends and on public holidays.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: 24 - 72 h

Score:

1.3

Max. score:

2

Reversibility:

not reversible

Results 2

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: 24 - 72 h

Score:

0.7

Max. score:

1

Reversibility:

fully reversible within: 21 d

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 24 - 72 h

Score:

3

Max. score:

3

Reversibility:

not reversible

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: 24 - 72 h

Score:

2.3

Max. score:

3

Reversibility:

not reversible

Irritant / corrosive response data:

Corneal opacity grade 2 at study termination.