Registration Dossier

Administrative data

Description of key information

In vivo skin irritation study in rabbits (OECD 404)

In vivo eye irritation study in rabbits (OECD 405)

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
Study period:
1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
July, 1992
Deviations:
not specified
GLP compliance:
yes (incl. certificate)
Specific details on test material used for the study:
TEST MATERIAL NAME (as stated in study report): TK 12437 (Trade Name: Irgastab CH 302)

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Sponsor; Batch No. 08520495
- Expiration date of the lot/batch: July, 1996
- Purity: within the product specifications

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Dr. K. Thomae GMBH, Chemisch-pharmazeutische Fabrik, D-7950 Biberach/Riss
- Weight at study initiation: 2360 to2560 g
- Housing: individually in metal cages
- Diet (e.g. ad libitum): Standard rabbit pellet - Nafag No. 814, Gossau, Switzerland; ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/-3 °C
- Humidity (%): 30-70 %
- Photoperiod (hrs dark / hrs light): 12 / 12
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
7 days
Number of animals:
3 female animals
Details on study design:
An area of at least 36 cm was shaved on both flanks of the animals approximately 24 hours before treatment. A gauze patch (approx.. 12-16 cm ) bearing 0.5 ml of the test article was applied to the right flank of each animal. A control gauze patch was applied to the contralateral flank. Both patches were moistened before application with distilled water.

The patches were loosely covered with an aluininum foil (approx. 36 cm ) and held in place for 4 hours by an adhesive tape (Isoplast, Isoplast AG, CH-5200 Brugg).

The animals were checked daily for systemic Symptoms and mortality (only findings reported).

The skin reactions were evaluated 1, 24, 48, and 72 hours after removing the gauze patches according to the OECD scoring system.

Bodyweight was recorded at start and on days 3 and 7 of the test.
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.33
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritant / corrosive response data:
see attached data table
Interpretation of results:
GHS criteria not met
Remarks:
Not classified by CLP Criteria
Conclusions:
In a guideline (OECD 404) in vivo skin irritation study, Irgastab CH 302 was not classified as a non-irritant to the skin of albino rabbits.
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
Study period:
1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
February 24, 1987
Deviations:
not specified
GLP compliance:
yes (incl. certificate)
Specific details on test material used for the study:
TEST MATERIAL NAME (as stated in study report): TK 12437 (Trade Name: Irgastab CH 302)

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Sponsor; Batch No. 08520495
- Expiration date of the lot/batch: July, 1996
- Purity: within the product specifications

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:
room temperature
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Dr. K. Thomae GMBH, Chemisch-pharmazeutische Fabrik, D-7950 Biberach/Riss
- Weight at study initiation: 2430 to 2600 g
- Housing: individually in metal cages
- Diet (e.g. ad libitum): Standard rabbit pellet - Nafag No. 814, Gossau, Switzerland; ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+/-3 °C
- Humidity (%): 30-70 %
- Photoperiod (hrs dark / hrs light): 12 / 12
Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
Single dose to left eye. The lids were then held together for about bne second in order to prevent loss of the test article.
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3 male animals
Details on study design:
SCORING SYSTEM: per guideline

TOOL USED TO ASSESS SCORE: slit lamp
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Reversibility:
fully reversible within: 24 hours
Irritant / corrosive response data:
No corneal, or iridal effects were seen in this study. Conjunctival redness was seen in all 3 treated eyes 1 hour after instillation (Grade 2), and in 2 of 3 treated eyes at 24 hours (Grade 1). Grade 1 chemosis was seen in all 3 treated eyes 1 hours after instillation. All eyes were normal at 48 hours post-treatment. See attached data table.
Interpretation of results:
GHS criteria not met
Remarks:
Not classified by CLP criteria
Conclusions:
In a guideline (OECD 405) in vivo eye irritation study, Irgastab CH 302 was not irritating to the rabbit eye. No corneal, or iridal effects were seen in this study. Conjunctival redness was seen in all 3 treated eyes 1 hour after instillation (Grade 2), and in 2 of 3 treated eyes at 24 hours (Grade 1). Grade 1 chemosis was seen in all 3 treated eyes 1 hours after instillation. All eyes were normal at 48 hours post-treatment.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation: individual animal erythema and edema scores (ave 24, 48, 72 h) ranged from 0.33 to 1.33. All reactions were fully reversible within 7 days.

Eye irritation: No corneal, or iridal effects were seen.  Individual animal conjuctival redness and chemosis scores (ave 24, 48, 72 h) ranged from 0 to 0.33.  All reactions were fully reversible within 48 hours.

Justification for classification or non-classification

Based on the available data, Irgastab CH 302 is not classified as a skin or eye irritant according to Regulation (EC) No 1272/2008.