Registration Dossier

Administrative data

Description of key information

The skin irritation test was performed according to EU-testing method B.4, using 4 NZW-rabbits. Deviated from Annex V (observations only at 72 hours after initial to administration) but with procedures more severe than Annex V (skin abraded prior to administration, occlusive dressing and 24-hour exposure period). Very slight erythema (grade I) was observed in one animal at 72 hours. The test item was assessed as non-irritant to rabbit skin.
The eye irritation test was performed according to EU-testing method B.5, using 4 NZW-rabbits. Deviated from Annex V (observations only at 24 hours and 7 days after initial to administration). At 24 hours mild conjunctival redness (grade I ) was observed in all animals and mild conjunctival redness (grade I ) in 3 animals) In 2 animals conjunctival redness was still apparent at 7 days, in 1 animal accompanied by discharge. Due to the irreversible conjunctival redness observed in two animals, the test item needs to be classified "Eye dam.1, H318".

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:
August-December 1986
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: no guideline study; not GLP-compliant
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study
Qualifier:
equivalent or similar to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
; deviated from Annex V (observations only at 72 hours after initial to administration) but with procedures more severe than Annex V (skin abraded prior to administration, occlusive dressing and 24-hour exposure period).
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
occlusive
Preparation of test site:
abraded
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 ml
Duration of treatment / exposure:
24 hours
Observation period:
Observation only at 72 hours
Number of animals:
4 animals were used
Details on study design:
Observations only at 72 hours after initial to administration) but with procedures more severe than Annex V (skin abraded prior to administration, occlusive dressing and 24-hour exposure period)
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72 h
Score:
0.2
Max. score:
1
Reversibility:
fully reversible
Irritant / corrosive response data:
The test item produced very mild dermal irritation. Only one of the four animals exhibited very slight (barely perceptible) erythema at 72 hours.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item was found to be non-irritant to rabbit skin.
Executive summary:

The skin irritation test was performed according to EU-testing method B.4, using 4 NZW-rabbits. Deviated from Annex V (observations only at 72 hours after initial to administration) but with procedures more severe than Annex V (skin abraded prior to administration, occlusive dressing and 24-hour exposure period). Very slight erythema (grade I) was observed in one animal at 72 hours. The test item was found to be non-irritant to rabbit 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
Study period:
August-December 1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: no guideline study; not GLP-compliant
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study
Qualifier:
equivalent or similar to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
; deviated from Annex V (observations only at 24 hours and 7 days)
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.1 ml test item was applied
Observation period (in vivo):
Observation at 24 hours and 7 days only
Number of animals or in vitro replicates:
4 animals were used
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0.75
Max. score:
1
Reversibility:
not fully reversible within: 7 d
Remarks on result:
other: redness
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24. 48 and 72 h
Score:
1
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 78 and 72 h
Score:
0.75
Reversibility:
fully reversible
Irritant / corrosive response data:
The test item produced very mild ocular irritation. All four animals exhibited slight conjunctival irritation (redness, chemosis) and iridial changes at 24 hours. By Day 7, two animals were free of ocular irritation; two animals continued to exhibit slight conjunctival irritation.
Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item showed irreversible conjunctival redness in two animals after seven days.
Executive summary:

The eye irritation test was performed according to EU-testing method B.5, using 4 NZW-rabbits. Deviated from Annex V (observations only at 24 hours and 7 days after initial to administration). At 24 hours mild conjunctival redness (score 1) was observed in all animals. In 2 animals conjunctival redness was still apparent at 7 days, in 1 animal accompanied by discharge. In 2 animals conjunctival redness was still apparent at 7 days, in 1 animal accompanied by discharge. Due to the irreversible conjunctival redness observed in two animals, the test item needs to be classified "Eye dam.1, H318".

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for selection of skin irritation / corrosion endpoint:
Reliable data from ELINCS-notification (Klimisch 2)

Justification for selection of eye irritation endpoint:
Reliable data from ELINCS-notification (Klimisch 2)

Effects on eye irritation: irritating

Justification for classification or non-classification

Based on the data available the substance needs to be classified and labelled as follows:

Regulation (EC) No 1272/2008

Eye damage 1

H318: Causes serious eye damage.

Directive 67/548/EEC / 1999/45/EC

Xi, irritant

R41: Risk of serious damage to eyes