Registration Dossier

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:
April-May 1984
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions. Substance is tested as a dilution (38-40%). This is not adequate to assess the irritation potential of undiluted Na3NTA.

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes
Remarks:
audited in-house

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Name of test compound: Rexene NTANa3 liquid (38-40%)
Appearance: clear yellow liquid
Date of receipt: 25 April 1984
Storage: ambient temperature

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, UK
- Age at study initiation: 11-13 weeks
- Weight at study initiation: 2.6-3.1 kg
- Housing: individually in metal cages with perforated floors
- Diet (e.g. ad libitum): ad lib
- Water (e.g. ad libitum): ad lib
- Acclimation period: yes but no further info


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


IN-LIFE DATES: From: 30 April To: 7 May 1984

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): undiluted
Duration of treatment / exposure:
single application
Observation period (in vivo):
1 h , and 1, 2, 3, 4 and 7 days
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM:
CORNEA
Degree of Opacity (most dense area used)
No opacity 0
Scattered or diffuse areas, 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 4

IRIS
Normal 0
Folds above normal, congestion, swelling, circumcorneal injection
(any or all 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 excluding cornea and iris)
Vessels normal 0
Vessels definitely injected above normal 1
More diffuse, deeper crimson red, indiviual vessels not easily discernible 2
Diffuse beefy red 3

Chemosis
No swelling 0
Any swelling above normal (includes nictitating membrane) 1
Obvious swelling with partial eversion of lids 2
Swelling with lids about half closed 3
Swelling with lids more than half closed 4


TOOL USED TO ASSESS SCORE: hand-held torch

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24/48/72 h
Score:
1.22
Max. score:
2
Reversibility:
fully reversible within: 4 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24/48/72 h
Score:
0.58
Max. score:
2
Reversibility:
fully reversible within: 3 days
Irritant / corrosive response data:
An initial pain reaction caused all three animals to vocalise immediately following instillation of the test substance. No corneal
damage or iridial inflammation was seen throughout the observation period. A diffuse crimson-red colouration of the conjunctivae
was seen in all three animals 1 hour after instillation and persisted in one animal 48 hours after instillation. Considerable swelling
with partial eversion of the eyelids was seen in two animals 1 hour after instillation only. A copious discharge was seen in all three animals, 1 hour after instillation only. The eyes of all three animals were normal 4 days after instillation. No other lesions were seen.

Any other information on results incl. tables

Summary of ocular reactions

Anim.

No.

Effect

Hours

Days after application

Mean

score cornea

Days

1/2/3

Mean score iritis

Days 1/2/3

Mean score redness Days

1/2/3

Mean score chemosis Days

1/2/3

1

1

2

3

4

7

2973 F

Cornea

Iris

Redness

Chemosis

0

0

2

2

0

0

1

1

0

0

1

1

0

0

1

0

0

0

0

0

0

0

0

0

0

0

1

0.67

2974 F

Cornea

Iris

Redness

Chemosis

0

0

2

2

0

0

1

0

0

0

1

1

0

0

1

0

0

0

0

0

0

0

0

0

0

0

1

0.33

2982 M

Cornea

Iris

Redness

Chemosis

0

0

2

1

0

0

2

1

0

0

2

1

0

0

1

0

0

0

0

0

0

0

0

0

0

0

1.67

0.67

Mean all anim.

0

0

1.22

0.58


Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
Based on the absence of corneal and iridial inflammation and a mean score of 1.22 for redness and 0.58 for chemosis, and the
absence of reactions 4 days after application, the test material, although slightly irritating to the eye, does not need classification
according to OECD-GHS.
Executive summary:

In a primary eye irritation study, 0.1 ml of Na3NTA (38-40%) was instilled into the conjunctival sac of 3 New Zealand White rabbits without subsequent washing. Animals then were observed for 7 days. Irritation was scored by the method of OECD 405.

No corneal and iridial inflammation were reported. The mean score redness was of 1.22 and 0.58 for chemosis. All effects were reversible within 4 days.

In this study, Na3NTA is not an eye irritant.