C,C'-azodi(formamide)

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

22 April - 06 May 1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted in accordance with official test guidelines (US Rederal Register) and in compliance with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

EPA OTS 798.4500 (Acute Eye Irritation)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

C,C'-azodi(formamide)

EC Number:

204-650-8

EC Name:

C,C'-azodi(formamide)

Cas Number:

123-77-3

Molecular formula:

C2H4N4O2

IUPAC Name:

diazene-1,2-dicarboxamide

Details on test material:

- Name of test material (as cited in study report): Unifoam AZ SO-NL
- Substance type: yellow powder
- Physical state: solid
- Analytical purity: 100%
- Purity test date: Not reported
- Lot/batch No.: Not reported
- Expiration date of the lot/batch: Not reported.
- Stability under test conditions: Not reported.
- Storage condition of test material: ambient temperature in the dark
- Other:

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Froxfield Rabbits, Petersfield, Hampshire, ENGLAND
- Age at study initiation: 8 to 15 weeks
- Weight at study initiation: 1.9 to 3.3 kg
- Housing:individually housed in metal cages with perforated floors
- Diet (e.g. ad libitum): SDS Standard Rabbit diet ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: acclimation reported but time period not specified.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19°C
- Humidity (%): 30-70%
- Air changes (per hr): 19
- Photoperiod (hrs dark / hrs light):12/12


IN-LIFE DATES: From: To: no data

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 48 mg (the weight occupying a volume of 0.1ml) placed in the lower everted lid of one eye of each animal.

Duration of treatment / exposure:

The eyelids were gently held together for one second before releasing.

Observation period (in vivo):

1 hour, and 1, 2, 3, 4, and 7 days after instillation.
Observation of the eyes was aided by the use of a handheld torch.

Number of animals or in vitro replicates:

6 females

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no


SCORING SYSTEM:
Cornea
Opacity: degree of density (area most dense taken for reading)
No ulceration or opacity 0
Scattered or diffuse areas of opacity (other than slight dulling of normal lustre), details of iris clearly visible 1*
Easily discernible translucent areas, details of iris slightly obscured 2*
Nacreous areas, no details of iris visible, size of pupil barely discernible 3*
Opaque cornea, iris not discernible through the opacity 4*

Iris
Normal 0
Markedly deepened 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) 1*
No reaction to light, haemorrhage, gross destruction (any or all of these) 2*

Conjunctivae
Redness (refers to palpebral and bulbar conjunctivae cornea and iris) Blood vessels normal 0
Some blood vessels definitely hyperaemic (injected) 1
Diffuse, crimson colour, individual vessels not easily discernible 2*
Diffuse, beefy red 3*

Chemosis (lids and/or nictitating membranes)
No swelling 0
Any swelling above normal (includes nictitating membranes) 1
Obvious swelling with partial eversion of lids 2*
Swelling with lids about half-closed 3*
Swelling with lids more than half-closed 4*

*Interpreted as a positive effect

TOOL USED TO ASSESS SCORE: hand torch

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

6 animals

Time point:

other: 1h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

6 animals

Time point:

other: 1h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

6 animals

Time point:

other: 1h

Score:

0.67

Max. score:

3

Reversibility:

fully reversible within: 48h

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

6 animals

Time point:

other: 1h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 24h

Results 5

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

6 animals

Time point:

other: 24h

Score:

0

Max. score:

4

Results 6

Irritation parameter:

iris score

Basis:

mean

Remarks:

6 animals

Time point:

other: 24h

Score:

0

Max. score:

2

Results 7

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

6 animals

Time point:

other: 24h

Score:

0.5

Max. score:

3

Reversibility:

fully reversible within: 48h

Results 8

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

6 animals

Time point:

other: 24h

Score:

0

Max. score:

4

Results 9

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

6 animals

Time point:

other: 48h

Score:

0

Max. score:

4

Results 10

Irritation parameter:

iris score

Basis:

mean

Remarks:

6 animals

Time point:

other: 48h

Score:

0

Max. score:

2

Results 11

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

6 animals

Time point:

other: 48h

Score:

0

Max. score:

3

Results 12

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

6 animals

Time point:

other: 48h

Score:

0

Max. score:

4

Irritant / corrosive response data:

None of the animals gave a "positive" response. No corneal damage or iridial inflammation were observed. Mild conjunctival irritation was observed in four of the animals, in one animal at the one hour reading only. The reactions in the other three animals had resolved two days after instillation of the test substance. The remaining two animals showed no response to treatment.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Instillation of Unifoam AZ SO-NL into the rabbit eye did not elicit a positve response in any of the six treated animals according to T.S.C.A. test criteria.

Executive summary:

An eye irritation test was performed to determine the potential of the test substance Unifoam AZ SO-NL to cause irritation in the eye (HLS 1988, OCI67/88638D). The study was conducted in accordance with US EPA test guidelines, and in compliance with GLP.

48 mg (the weight equialent to 0.1 mL) of the test substance was instilled into one eye of each of six New Zealand White rabbits. The untreated eye in each rabbit was used as a reference by which to compare the treated eye. Examinations of the eyes were made 1 hour and 1, 2, 3, 4, and 7 days after instillation. Observation of the eyes was aided by the use of a handheld torch.

None of the animals gave a "positive" response. No corneal damage or iridial inflammation were observed. Mild conjunctival irritation was observed in four of the animals, in one animal at the one hour reading only. The reactions in the other three animals had resolved two days after instillation of the test substance. The remaining two animals showed no response to treatment.

Instillation of Unifoam AZ SO-NL into the rabbit eye did not elicit a positive response in any of the six treated animals according to T.S.C.A. test criteria.