Registration Dossier

Administrative data

Description of key information

The test material produced a primary irritation index of 4.0 and was classified as a moderate irritant to rabbit skin according to the Draize classification scheme.
The test material produced a maximum group mean score of 6/0 and was classified as a minimal irritant (Class 3 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.

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:
2003
Reliability:
1 (reliable without restriction)
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
The temp. and relative humidity were set to achieve limits of 17 to 23 deg. C and 30 to 70% respectively. The rate of air exchange was at least 15 changes per hour and lighting was controlled.
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Duration of treatment / exposure:
The study was performed to assess the irritancy potential of the test material following single, 3-minute, 1 and 4-hour, semi-occluded applications to the intact rabbit skin.
Observation period:
25
Number of animals:
3 rabbits
Details on study design:
At each test site a quantity of 0.5ml of the test material was introduced under a 2.5cm x 2.5 cm cotton gauze patch and placed in position on the shorn skin. Each patch was secured in positoin with a strip of surgical adhsesive tape. One patch was removed at each of thre time points: 3 minutes, 1 hour and 4 hours after applicatoin. After consideration of the skin reactions produced in the first animal, two additional animals were treated with 0.5ml of test material. one patch was applied to the back of each rabbit , and was allowed to remain in contact with the skin for a period of four hours.
Approximately one hour following the removal of the patches, and 24, 48 and 72 hours later, the test sites were examined for evidence of primary irritaiton and scored.
Irritation parameter:
primary dermal irritation index (PDII)
Time point:
other: 24,72-hour
Score:
ca. 4
Reversibility:
fully reversible within: 14 days
Irritant / corrosive response data:
4-hour Exposure Period:The individual scores for erythema/eshcar and oedema are given in Talbe 1.
Well-defined erythema and slight to moderate oedema were noted at all treated skin sites on hour after patch removal with well-defined erythema and slight oedema at the 24,48 and 72-hour observatoins. Loss of skin elasticity was noted at all treated sites at the 72-hour observation. Severe desquamation, which prevented evaluation of erythema and oedema, was noted at two treated skin sites with moderate desquamation noted at one other treated skin site at the 7-day observation. All treated skin sites appeared notrmal at the 14-day observation.

1-Hour Exposure Period: The individual scores for erythema/escjar amd pede,a are govem om Appendix 1. Well-defined erythema and very slight oedema were npoted at the treated skin site at the 24.48 and 72-hour observations. Loss of skin elasticity was noted at the treated skin site at the 72-hour observation. Slight desquamation was noted at the treated skin site at the 7-day observation. The treated skinsite appeared normal at the 14-day oservation.

3-Minute Exposure Period: The individual scores for erythema/eschar and oedema are given in Appendix 1. No evidence of skin irritation was noted during the study.
Conclusions:

The test material produced a primary irritation index of 4.0 and was classified as a moderate irritant to rabbit skin accordingt to the Draize3 classification scheme. No corrosive effects were noted.
Executive summary:

The study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit.

A single 4 -hour, semi-occluded application of the test material to the intact skin of three rabbits produced well-defined erythema and slight to moderate oedema. Other skin reactions noted were loss of skin elasticity and moderate or sever desquamation. All treated skin sites appeared normal at the14 -day observation. No corrosive effects were noted.

3 -minute and 1 -hour semi-occluded applications of the test material to the intact skin of one rabbit produced no corrosive effects.

Conclusion: The test material produced a primary irritation index of 4.0 and was classified as a moderate irritant to rabbit skin according to the Draize classification scheme.

The test material was also classiifed as irritant accoridng to the EU labeling regulation.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (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:
2003
Reliability:
1 (reliable without restriction)
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
The temp. and relative humidity were set to achieve limits of 17 to 23 deg. C and 30 to 70% respectively. The rate of air exchange was at least 15 changes per hour and lighting was controlled.
Vehicle:
unchanged (no vehicle)
Controls:
other: The left untreated eye was used for control
Amount / concentration applied:
A volume of 0.1m of the test material was placed into the conjunctival sac of the right eye.
Duration of treatment / exposure:
1 hr, 24 hr, 48hr, 72hr
Observation period (in vivo):
Assessment of ocular damage/irritation was made appr. 1 hour and 24, 48 and 72 hours following treatment.
Number of animals or in vitro replicates:
Initially a single rabbit was treated. After consideration of the ocular responses, two additional animlas were treated.
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1hr, 24hr, 48 hr, 72hr
Score:
0
Max. score:
0
Reversibility:
other: no effect
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1hr, 24hr, 48 hr, 72hr
Score:
0
Max. score:
0
Reversibility:
other: no effect
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1hr, 24hr, 48 hr, 72hr
Score:
0
Max. score:
0
Reversibility:
other: no effect
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1hr, 24hr, 48 hr, 72hr
Score:
0
Max. score:
0
Reversibility:
other: no effect
Irritant / corrosive response data:
No conrneal or iridial effects were noted during hte study.
Minimal conjunctival irritation was noted in all treated eyes one hour after treatment.
All treated eye appeared normal at the 24-hour observation.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
A single application of the test material to the non-irrigated eye of three rabbits produced minimal conjuctival irritation. All treated eyes appeared normal at the 24-hour observation
Executive summary:

Introduction: The study was performed to assess the irritancy potential of the test material to the eye of the New Zealand White rabbity. The method was designed to meet the requirenmnets of the following:


• OECD Guidelines for the Testing of Chemicals No. 405 “Acute Eye IrritationlCorrosion” (adopted 24 February 1987)
• Commission Directive 92/69/EEC Method B5 Acute Toxicity (Eye Irritation)

Result. A single application of the test material to the non-irrigated eye of three rabbits produced minimal conjunctival irritation. All treated eyes appeared normal at the 24-hour observation.




• OECD Guidelines for the Testing of Chemicals No. 405 “Acute Eye IrritationlCorrosion” (adopted 24 February 1987)


• Commission Directive 92/69/EEC Method B5 Acute Toxicity (Eye Irritation)


Result. A single application of the test material to the non-irrigated eye of three rabbits produced minimal conjunctival irritation. All treated eyes appeared normal at the 24-hour observation.


Conclusion. The test material produced a maximum group mean score of 6.0 and was classified as a minimal irritant (Class 3 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.


The test material did not meet the criteria for classification as irritant according to EU labelling regulations Commission Directive 93/21/EEC.



The test material did not meet the criteria for classification as irritant according to EU labelling regulations Commission Directive 93/21/EEC.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Justification for selection of skin irritation / corrosion endpoint:
Availability of Kllimish 1 study.

Justification for selection of eye irritation endpoint:
Availability of Kllimish 1 study.

Effects on skin irritation/corrosion: moderately irritating

Justification for classification or non-classification

The test material did not meet the criteria for classification as irritant to eye according to the EU labelling regulations Commission Directive 92/21/EEC.

The test material is classifiied as irritant to skin according to EU labeling regulations Commission Directive 92/21/EEC.