Registration Dossier

Administrative data

Description of key information

The test was conducted according to OECD guideline 404 in compliance with GLP.

The irritatitive/corrosive effects of the substance were investigated in 3 female rabbits.
Under the experimental conditions employed CA 1139 A induced slight erythema reactions when applied to the clipped albino rabbit skin. The reactions were observed only one hour after removing the bandages. Because the mean values of the recordings 24 to 72 hours after application are scored zero, CA 1139 A can be classified as non-irritating according to the Commission Directive 83/467/EEC.
The test was conducted according to OECD guideline 405 in compliance with GLP.
The eye irritatitive/corrosive effects of the substance were investigated in 3 male rabbits.
Under the experimental conditions employed CA 1139 A induced irritation of the cornea, iris and conjunctiva.
One hour after instillation of the test article mydriasis was noticed in the treated eye of all animals. On day 7 corneal bulging, opacity of the lower part of the cornea and pannus was observed in animal No. 513, whereas in animal No. 753 corneal bulging and vascularisation was seen. On day 7 the two animals were killed for animal protective reasons. In animal No. 663 the eye reactions were not reversible until the end of the observation period on day 21.
On account of the irreversible eye reactions observed, CA 1139 A has to be classified as corrosive according to OECD Guideline No. 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:
May 1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
This study has been performed in compliance with Good Laboratory Practice (GLP) in Switzerland, Procedures and Principles, March 1986, issued by the Federal Department of the Interior and the Intercantonal Office for the Control of Medicaments, Switzerlan
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: gauze patches moistened with 0.5% (w/v) carboxymethylcellulose in 0.1% (w/v) aqueous polysorbate 80
Controls:
other: contralateral flank was used as control
Duration of treatment / exposure:
4 hours
Observation period:
The skin reactions were evaluated 1, 24, 48, and 72 hours after removing the gauze patches according to the OECD scoring system.
Number of animals:
3
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Interpretation of results:
GHS criteria not met
Conclusions:
Because no reactions were observed at 24 hours to 72 hours after removing the bandages, the substance can be classified according to the EEC classification as non-irritant in albino rabbits.
Executive summary:

The test was conducted according to OECD guideline 404 in compliance with GLP.

The irritatitive/corrosive effects of the substance were investigated in 3 female rabbits.

Under the experimental conditions employed CA 1139 A induced slight erythema reactions when applied to the clipped albino rabbit skin. The reactions were observed only one hour after removing the bandages. Because the mean values of the recordings 24 to 72 hours after application are scored zero, CA 1139 A can be classified as non-irritating according to the Commission Directive 83/467/EEC.

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:
May - June 1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
This study has been performed in compliance with Good Laboratory Practice (GLP) in Switzerland, Procedures and Principles, March 1986, issued by the Federal Department of the Interior and the Intercantonal Office for the Control of Medicaments, Switzerlan
Species:
rabbit
Strain:
New Zealand White
Vehicle:
unchanged (no vehicle)
Controls:
other: other (right) eye served as control
Duration of treatment / exposure:
one-time administration
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
3
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 10 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Irritant / corrosive response data:
Animal 2 has to be killed on day 7 due to proteictive reason
Animal 3 has to be killed on day 7 due to proteictive reason

Bodyweights [g]

Animal No.              663 / M                     513 / M                     753 / M

At start of test

2260

2390

2740

After 3 days

2980

2450

2780

After 7 days

3030

2530*

2890*

After 14 days

3150

--

--

After 21 days (end *)

3190

--

--

M = male

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
On account of the irreversible eye reactions observed, CA 1139 A has to be classified as corrosive according to OECD Guideline 405.
Executive summary:

The test was conducted according to OECD guideline 405 in compliance with GLP.

The eye irritatitive/corrosive effects of the substance were investigated in 3 male rabbits.

Under the experimental conditions employed CA 1139 A induced irritation of the cornea, iris and conjunctiva.

One hour after instillation of the test article mydriasis was noticed in the treated eye of all animals. On day 7 corneal bulging, opacity of the lower part of the cornea and pannus was observed in animal No. 513, whereas in animal No. 753 corneal bulging and vascularisation was seen. On day 7 the two animals were killed for animal protective reasons. In animal No. 663 the eye reactions were not reversible until the end of the observation period on day 21.

On account of the irreversible eye reactions observed, CA 1139 A has to be classified as corrosive according to OECD Guideline No. 405.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irreversible damage)

Additional information

Justification for classification or non-classification

Dermal irritation: The mean values of the recordings 24 to 72 hours after application are scored zero. Therefore, the substance can be classified as non-irritant according to Commision Directive 83/467/EEC.

Eye irritation: The substance induced irritation of the cornea, iris and conjunctiva. On account of the irreversible eye reactions observed, CA 1139 A has to be classified as corrosive according to OECD Guideline No. 405.