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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
9 January 1984 to 23 January 1984
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report date:
1984

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
N-[2-[(2-cyano-4,6-dinitrophenyl)azo]-5-(diethylamino)phenyl]acetamide
EC Number:
246-058-2
EC Name:
N-[2-[(2-cyano-4,6-dinitrophenyl)azo]-5-(diethylamino)phenyl]acetamide
Cas Number:
24170-60-3
Molecular formula:
C19H19N7O5
IUPAC Name:
N-{2-[(2-cyano-4,6-dinitrophenyl)diazenyl]-5-(diethylamino)phenyl}acetamide
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
None
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch number of test material: EN 43'693.12

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Stability under storage conditions: until October 1988

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Age at study initiation: 12 - 14 weeks
- Weight at study initiation: 2110-2240 g
- Housing: Animals were housed individually in metal cages.
- Diet: Rabbit food, NAFAG, No. 814 Tox, NAFAG AG, Gossau, SG (Switzerland) ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%): 30-70
- Air changes (per hr): approximately 15 air changes/h
- Photoperiod (hrs dark / hrs light): 12 hours light/day

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The left eye of each animal remained untreated and served as the control.
Amount / concentration applied:
0.1 g of the test article was applied.
Duration of treatment / exposure:
One single application.
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
3 males
Details on study design:
0.1 g of the test article was placed into the conjunctival sac of the right eye of each animal, after gently pulling away the lower lid from the eyeball. The lids were then held together for about one second in order to prevent loss of the test material.
The left eye remained untreated and served as the control.

Scoring and assessment of local reactions:
The ocular reactions were examined 1, 24, 48, and 72 hours after substance instillation and again during the following observation period.
The ocular irritation scores were evaluated according to the scoring system.
The irritating and/or corrosive potential of the test article (theoretical range: non irritant - extremely irritant) was assessed on the basis of the maximum irritant effect observed
- in one or several of the ocular tissues (conjunctiva, iris, cornea), observed over the range of observation time
- in one or more animals and taking into account the reversibility of the effect.

SCORING SYSTEM: Evaluation score for ocular lesions.

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 area, details of iris slightly obscured: 2*
- Nacrous area, 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 there of, iris still reacting to light (sluggish reaction is positive): 1*
- No reaction to light , haemorrhage, gross destruction (any or a l l 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 nictating membranes
- No swelling: 0
- Any swelling above normal (includes nictating 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*

*Starred figures indicate positive effect.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
3 animal
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Remarks:
3 animal
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
mean
Remarks:
3 animal
Time point:
24/48/72 h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
3 animal
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
The animals were free of findings at the 48 hours scoring. The animals showed a normal body weight development.

Any other information on results incl. tables

CORNEA

Animal No./Sex

19/M

20/M

21/M

After 1 h

1

0

1

After 24 h

0

0

0

After 48 h

0

0

0

After 72 h

0

0

0

IRIS

After 1 h

0

0

0

After 24 h

0

0

0

After 48 h

0

0

0

After 72 h

0

0

0

CONJUNCTIVA redness in bulbar and palpebral membranes

After 1 h

2

2

2

After 24 h

1

0

1

After 48 h

0

0

0

After 72 h

0

0

0

CONJUNCTIVA chemosis in lids and nictating membranes

After 1 h

2

2

2

After 24 h

0

0

0

After 48 h

0

0

0

After 72 h

0

0

0

 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
FAT 36'156/A is considered as non-irritant when applied to the rabbit eye.
Executive summary:

The experiment was performed to determine the potential of FAT 36156/A to induce irritation/corrosion in New Zealand White rabbits according to the OECD Guideline 405. Three male rabbits were used in this study. 0.1 g of the test item was placed into the conjunctival sac of the right eye of each animal, after gently pulling away the lower lid from the eyeball. The lids were held together for about on second in order to prevent the loss of the test material. The left eye remained untreated and served as the control. The ocular reaction was examined 1, 24, 48 and 72 hours after substance instillation.


The test was finished after 3 observations days. The animals showed a normal body weight gain.Two animals showed conjunctival redness of score 1 at 24 h observation period which was reversed at 48 h observation period. No other reactions to treatment were recorded during the whole observation period.


 


Based on the results, FAT 36'156/A is considered as non-irritant when applied to the rabbit eye.