Registration Dossier

Administrative data

Description of key information

Key study: Test method EU Method B.4. GLP study. The substance is not irritating to the skin.
Key study: Test method EU Method B.5. GLP study. The substance is not irritating to the eye.

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: Test method according to 92/69/EWG, B.4. GLP study.
Qualifier:
according to guideline
Guideline:
other: 92/69/EWG, B.4
Deviations:
not specified
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
SPF animals.
Type of coverage:
semiocclusive
Preparation of test site:
not specified
Vehicle:
other: moistened substance
Controls:
not specified
Amount / concentration applied:
500 mg.
Duration of treatment / exposure:
4 h.
Observation period:
72 h.
Number of animals:
3
Details on study design:
SCORING SYSTEM: B.4 scoring system.
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: Overall at 24, 48 and 72 h.
Score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: Overall at 24, 48 and 72 h.
Score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: Overall at 24, 48 and 72 h.
Score:
0
Irritation parameter:
erythema score
Max. score:
0
Remarks on result:
other: Max. duration: 72 h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: Overall at 24, 48 and 72 h.
Score:
0
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
(score 2)
Time point:
other: Overall at 24, 48 and 72 h.
Score:
0
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
(score 3)
Time point:
other: Overall at 24, 48 and 72 h.
Score:
0
Irritation parameter:
edema score
Max. score:
0
Remarks on result:
other: Max. duration: 72 h; Max. value at end of observation period: 0 (related to all animals)
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 3 days.
Other effects:
During the observation period orange staining occurred on
the treated skin.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance did not caused skin irritation/corrotion in rabbits when 500 g of moistened substance was applied to rabbits for 4 hours under semiocclusive conditions.
Executive summary:

A skin irritation test was performed according to 92/69/EWG, B.4 under GLP conditions. The test moistened substance was applied to 3 rabbits under semiocclusive conditions for 4 hours. The post-exposure observation perdiod was 72 hours. All scores for erythema and oedema were 0 and the changes observed were fully reversible within 3 days, the only remarcable event was that during observation period orange staining occured on the treated skin.

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: Test method according to 92/69/EWG, B.5. GLP study.
Qualifier:
according to guideline
Guideline:
other: 92/69/EWG, B.5
Deviations:
not specified
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
40 mg.
Duration of treatment / exposure:
Eye instillation.
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
Remnants of the test substance were present in the eyes of all animals up to 24 - 48 h after instillation. The test substance could only partly be removed by rinsing the treated eyes immediately after the 24 h observation.

SCORING SYSTEM: B.5 scoring system.

TOOL USED TO ASSESS SCORE: fluorescein (2%).
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: Overall at 24, 48 and 72 h.
Score:
1.67
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: Overall at 24, 48 and 72 h.
Score:
2
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: Overall at 24, 48 and 72 h.
Score:
1.33
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Max. score:
2
Remarks on result:
other: Max. duration: h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: Overall at 24, 48 and 72 h.
Score:
0.33
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: Overall at 24, 48 and 72 h.
Score:
0.67
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: Overall at 24, 48 and 72 h.
Score:
0.33
Irritation parameter:
chemosis score
Max. score:
2
Remarks on result:
other: Max. duration: 24 h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: Overall at 24, 48 and 72 h.
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: Overall at 24, 48 and 72 h.
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: Overall at 24, 48 and 72 h.
Score:
0
Irritation parameter:
cornea opacity score
Max. score:
0
Remarks on result:
other: Max. duration: 0 h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: Overall at 24, 48 and 72 h.
Score:
0
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: Overall at 24, 48 and 72 h.
Score:
0
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: Overall at 24, 48 and 72 h.
Score:
0
Irritation parameter:
iris score
Max. score:
0
Remarks on result:
other: Max. duration: 0 h; Max. value at end of observation period: 0 (related to all animals)
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 15 days.
Other effects:
Instillation of approximately 40 mg substance into one eye of each of three rabbits resulted in irritation of the conjunctivae, which consisted of redness, chemosis and discharge. The irritation had completely resolved within 7 days in one animal and within 15 days in the other two animals.
No iridic irritation or corneal opacity were observed, and treatment of the eyes with 2% fluorescein, 24 hours after test substance instillation revealed no corneal epithelial damage in any of the animals.
There was no evidence of ocular corrosion.
Remnants of the test substance were present in the eyes of all animals up to 24 - 48 h after instillation. The test substance could only partly be removed by rinsing the treated eyes immediately after the 24 h observation.
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
When instillated into eyes of rabbits, the test substance caused irritation of conjunctivae, chemosis and discharge but the irritation completely resolved in 15 days and no iridic irritation or corneal opacitiy were observed.
Executive summary:

A eye irritation test was performed according to 92/69/EWG, B.5. 40 mg of the test substance was instillated into one eye of each three rabbits. The instillationr resulted in irritation of the conjunctivae, which consisted of redness, chemosis and discharge. The irritation had completely resolved within 7 days in one animal and within 15 days in the other two animals. No iridic irritation or corneal opacity were observed, and treatment of the eyes with 2% fluorescein, 24 hours after test substance instillation revealed no corneal epithelial damage in any of the animals.There was no evidence of ocular corrosion.

Remnants of the test substance were present in the eyes of all animals up to 24 - 48 h after instillation. The test substance could only partly be removed by rinsing the treated eyes immediately after the 24-h observation.

No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

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

Additional information

Key study: A skin irritation test was performed according to 92/69/EWG, B.4 under GLP conditions. The test moistened substance was applied to 3 rabbits under semiocclusive conditions for 4 hours. The post-exposure observation perdiod was 72 hours. All scores for erythema and oedema were 0 and the changes observed were fully reversible within 3 days. The test substance was determined to be not irritating to the skin.

Key study: A eye irritation test was performed according to 92/69/EWG, B.5. 40 mg of the test substance was instillated into one eye of each three rabbits. The instillationr resulted in irritation of the conjunctivae, which consisted of redness, chemosis and discharge. The irritation had completely resolved within 7 days in one animal and within 15 days in the other two animals. No iridic irritation or corneal opacity were observed, and treatment of the eyes with 2% fluorescein, 24 hours after test substance instillation revealed no corneal epithelial damage in any of the animals.The test substance was determined to be not irritating to the eye.


Justification for selection of skin irritation / corrosion endpoint:
Only one study available.

Justification for selection of eye irritation endpoint:
Only one study available.

Justification for classification or non-classification

Based on available information, the substance is not classified for irritation/corrosion according to CLP Regulation (EU) No 1272/2008.