Registration Dossier

Administrative data

Description of key information

Skin irritation/corrosion: EPA OPP 81-5 (Acute Dermal Irritation)

Rabbit, 4h semiocclusive treatment of clipped intact skin with 0,5 g NA-11 moistened with 0,9% saline: no effects observed.

Eye irritation: EPA OPP 81-4 (Acute Eye Irritation)

0.03 g NA-11 instilled in rabbit eyes (6 animals), eyes kept unwashed. Observation time points: 1, 24, 48, 72 h after instillation. Slight irritation after application disappeared within 72 hours.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well documented and reported study fully adequate for assessment. The study was conducted according to internationally accepted technical guidelines and in compliance with GLP in a recognized contract research organization.
Qualifier:
according to
Guideline:
EPA OPP 81-5 (Acute Dermal Irritation)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Adult albino rabbits, Hra:(NZW)SPF
- Source:Hazleton Research Products, Inc., Denver PA
- Weight at study initiation: 2032 - 2116 g
- Housing: individually in screen-bottom cages,
- husbandry and housing: addording to "Guide for the Care and Use of Laboratory Animals" (NIH Publication No. 86-23 (revised 1985)).
- Diet (e.g. ad libitum): measured, High Fiber Rabbit Chow® 5326, Purina Mills, Inc.
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days
- Temperature (°C): 18.9-23.3
- Humidity (%):48 to 55

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
physiological saline
Controls:
no
Amount / concentration applied:
- Amount(s) applied (volume or weight with unit): 0,5 g test material (moistened with 0,9% saline)

VEHICLE
- Concentration (if solution): 0,9% saline
Duration of treatment / exposure:
4 hours
Observation period:
30 minutes = 4 hours; 24, 48, and 72 hours after patch removal
Number of animals:
6 (3 male, 3 female)
Details on study design:
TEST SITE
- Area of exposure: 2,5 cm x 2,5 cm
- Type of wrap if used: gauze patch secured with paper tape, loosely overwrapped with Saran Wrap® and secured with Elastoplast® tape to provide a
semiocclusive dressing

REMOVAL OF TEST SUBSTANCE
- Washing (if done): lukewarm water
- Time after start of exposure: 4 h

SCORING SYSTEM:according to the Draize technique (Draize, J.H. 1975)
Irritation parameter:
erythema score
Basis:
mean
Remarks:
over 6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
over 6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
no erythema, no edema observed
Interpretation of results:
other: not irritant
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
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: Well documented and reported study fully adequate for assessment. The study was conducted according to an internationally accepted technical guideline and in compliance with GLP in a recognized contract research organization.
Qualifier:
according to
Guideline:
EPA OPP 81-4 (Acute Eye Irritation)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Species, Strain: albino rabbits, Hra:(NZW)SPF
- Source: Hazleton Research Products, Inc., Denver PA
- Weight prior to dosing (Day 1): 2006 - 2224 g
- Husbandry and housing: individually in screen-bottom cages; according to standards outlined in the "Guide for the Care and Use of Laboratory" (NIH Publication.86-23 (revised 1985)).
- Diet (ad libitum): measured amount of High Fiber Rabbit Chow® 5326, Purina Mills, Inc.,
- Water(ad libitum): ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.9 - 23.3
- Humidity (%): 48 - 70

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1-ml dose, 0.03 g
Duration of treatment / exposure:
Eyes kept unwashed.
Observation period (in vivo):
observations: 1, 24, 48, and 72 hours after treatment
Number of animals or in vitro replicates:
3 male, 3 female rabbits
Details on study design:
SCORING SYSTEM: Irritation was graded and scored according to the Draize technique.

TOOL USED TO ASSESS SCORE: At the 72-hour reading, sodium fluorescein was used to aid in revealing possible corneal injury.

Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
over 6 animals and 4 time points
Time point:
24/48/72 h
Score:
0
Max. score:
320
Irritation parameter:
iris score
Basis:
mean
Remarks:
over 6 animals
Time point:
24 h
Score:
1.7
Max. score:
10
Reversibility:
fully reversible within: 48-72 h
Remarks on result:
other: 3 of 6 animals concerned
Irritation parameter:
iris score
Basis:
mean
Remarks:
over 6 animals
Time point:
48 h
Score:
0.8
Max. score:
10
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: 3 of 6 animals concerned
Irritation parameter:
iris score
Basis:
mean
Remarks:
over 6 animals
Time point:
72 h
Score:
0
Max. score:
10
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
over 6 animals
Time point:
24 h
Score:
6.7
Max. score:
20
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: 2 animals: symptom "discharge" resolved
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
over 6 animals
Time point:
48 h
Score:
6
Max. score:
20
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: redness of conjunctivae remained in all animals, chemosis only in 1 animal
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
over 6 animals
Time point:
72 h
Score:
0
Max. score:
20
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
over 6 animals
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 24 h
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
over 6 animals
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
over 6 animals
Time point:
72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
The test material produced iridal involvement and moderate conjunctival irritation when instilled into the eyes of six albino rabbits.
All ocular irritation cleared within 72 hours after instillation of the test material.
Interpretation of results:
other: not irritating
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

In view of absence of any effects on clipped intact skin treated for 4 hours with NA-11 classification regarding skin irritation or corrosion according to EU classification rules [REGULATION (EC) 1272/2008] is not necessary.

 

The reversible mild irritation of neat NA-11 in rabbit eye does not necessitate classification for eye irritation [REGULATION (EC) 1272/2008].