Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1989-11-06 till 1989-11-20
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Reliable without restrictions; Guideline study (OECD 405) according to GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test matereial (as cited in study report): Acetoguanamine
- Lot/batch No.: 10/08/89 AG
- Purity: 99.2 %

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Froxfield Farms (U.K.) Ltd., Petersfield, Hampshire, England.
- Age at study initiation: 12 to 13 weeks of age
- Weight at study initiation: 2.8 to 3.0 kg
- Housing: individually housed in metal cages with perforated floors
- Diet (e.g. ad libitum): free access to SDS Standard Rabbit Diet
- Water (e.g. ad libitum): free access to tap water
- Acclimation period: yes, but no period of time mentioned

ENVIRONMENTAL CONDITIONS
- Temperature (°C): approx. 19 °C
- Humidity (%): 30-70 %
- Air changes (per hr): 19 air changes per hour
- Photoperiod (hrs dark / hrs light): lightning was controlled to give 12 hours of artificial light (0700-1900 hours) in each 24 hour period.

Test system

Vehicle:
not specified
Controls:
not required
Amount / concentration applied:
Approx. 85 mg of Acetoguanamine, the weight occupying a volume of 0.1 ml.
Duration of treatment / exposure:
Acetoguanamine was placed into the lower everted lid of one eye of each animal. The eyelids were then gently held together for one second before releasing. The contralateral eye remained untreated and served as a control.
Observation period (in vivo):
Examination of the eyes was made after 1 hour and 1, 2, 3, 4 and 7 days after instillation.
Number of animals or in vitro replicates:
three

Results and discussion

In vivo

Other effects:
The numerical scores awarded to the ocular reactions elicited by Acetoguanamine, are given in Table 1.
A corneal opacity developed in one animal 24 h after instillation and was still visible 4 d following instillation. The opacity had resolved 7 days after instillation.
No iridial inflammation was seen throughtout oberservation period.
A diffuse crimson-red colouration of the conjunctivae was observed, 1 h after instillation only, in all three animals.
All conjuctival reactions had resolved 24 or 48 h after instillation.

Any other information on results incl. tables

TABLE 1: Ocular reactions elicited by Acetoguanamine.

Rabbit Number and Sex

Bodyweight

(Day 1)

Region of Eye

One hour

Day after instillation

1

2

3

4

7

812

female

2980 g

Corea

Density

0

0

0

0

0

0

Area

0

0

0

0

0

0

Iris

0

0

0

0

0

0

Conjunctivae

Redness

2

0

0

0

0

0

Chemosis

1

0

0

0

0

0

838

female

2870 g

Corea

Density

0

0

0

0

0

0

Area

0

0

0

0

0

0

Iris

0

0

0

0

0

0

Conjunctivae

Redness

2

0

0

0

0

0

Chemosis

1

0

0

0

0

0

839

female

3000 g

Corea

Density

0

2

1

1

1

0

Area

0

1

1

1

1

0

Iris

0

0

0

0

0

0

Conjunctivae

Redness

2

1

0

0

0

0

Chemosis

1

1

0

0

0

0

SCORING SYSTEM:

Cornea:

Opacity: degree of density (area most dense taken from reading)

0       No ulceration or opacity

1       Scattered or diffuse areas of opacity (other than slight dulling of normal lustre), details of iris clearly visible

2       Easily discernible translucent areas, details of iris slightly obscured

3       Nacrous areas, no details of iris visible, size of pupil barely discernible

4       Opaque cornea, iris not discernible through the opacity

Area of cornea involved:

1       One quarter (or less) but not zero

2       Greater than one quarter, but less then half

3      Greater than half, but less than three quarters

4       Greater than three quarters, up to whole area

Iris:

0       Normal

1       Markedly depened rugae, congestion, swelling, moderate circumcorneal hyperaemia or injection, any of these or combination              of any thereof, iris still reacting to light (sluggish reaction is positive)

2       No reaction to light, haemorrhage, gross destruction (any or all of these)

Conjunctivae:

Redness (refers to palpebral and bulbar conjunctivae cornea and iris)

0       Blood vessels normal

1       Some blood vessels definitely hyperaemic (injected)

2       Diffuse, crimson colour, individual vessels not easily discernible

3       Diffuse, beefy red

Chemosis (lids and/or nictitating membranes)

0       No swelling

1       Any swelling above normal (includes nictitating membranes)

2       Obvious swelling with partial eversion of lids

3       Swelling with lids about half-closed

4      Swelling with lids more than half-closed

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Acetoguanamine elicites transient, corneal opacification and temporary well-defined conjuctival reactions. Nevertheless this effects do not lead to a classification of the test substance.
Executive summary:

In an eye irritation study according to OECD 405 approx. 85 mg of Acetoguanamine, the weight occupying a volume of 0.1 mL was placed into the lower lid of one eye of each of the test animals (three adult New Zealand White rabbits). Examination of the eyes was made after 1 hour, and 1, 2, 3, 4 and 7 days after instillation. Irritation was scored and it was determined that Acetoguanamine elicites only transient, corneal opacification and temporary well-defined conjuctival reactions. Nevertheless this effects do not lead to a classification of the test substance.