Registration Dossier

Administrative data

Description of key information

A valid skin irritation/corrosion study according OECD 404 and a valid eye irritation study according OECD 405 is available. Additional studies for skin and eye irritation from a secondary source are also available - but no score value are quoted.

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: GLP guideline study
Reference:
Composition 0
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Principles of method if other than guideline:
3 white New-Zealand rabbits were treated with 0.5 ml of undiluted test substance. The test item remained under semiocclusion on the skin for 4 hours. Treated animals were inspected for skin effects (erythma, oedema) after removal of patches and after 1, 2, 3 and 7 days. Total observation time was 7 days
GLP compliance:
yes
Test material information:
Composition 1
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Duration of treatment / exposure:
4 hours
Observation period:
7 days
Number of animals:
3 male rabbits
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, and 72 h
Score:
0.9
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, and 72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Interpretation of results:
not irritating
Remarks:
Migrated information
Executive summary:

Method: Three white New-Zealand rabbits were treated with 0.5 ml of undiluted test substance. The test item remained under semiocclusion on the skin for 4 hours. Treated animals were inspected for skin effects (erythma, oedema) after removal of patches and after 1, 2, 3 and 7 days. Total observation time was 7 days

Result: slightly irritating to the skin, but not sufficient for classification

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: GLP guideline study
Reference:
Composition 0
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
100 µl test compound was instilled into the conjunctival sac of one eye of each of 3 rabbits. The lids were then gently held together for about one second. the other eye remained untreated and served as control. The treated eye was washed out with physiological NaCl solution 24 hours after instillation of the test compound
GLP compliance:
yes
Test material information:
Composition 1
Species:
rabbit
Strain:
New Zealand White
Vehicle:
unchanged (no vehicle)
Controls:
not required
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
14 days
Number of animals or in vitro replicates:
3 male rabbits
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, and 72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable - score = 0 at any time point
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, and 72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, and 72 h
Score:
0.9
Max. score:
4
Reversibility:
fully reversible within: 7 days

The test substance was slight to moderately irritating to the eye. According Directive 67/548 EEC a classification is not required - however according GHS a classification a Eye Irrit.2; H319 is justified based on a cornea score > 1and a conjunctiva score > 2.

Executive summary:

100 µl test compound was instilled into the conjunctival sac of one eye of each of 3 rabbits. The lids were then gently held together for about one second. the other eye remained untreated and served as control. The treated eye was washed out with physiological NaCl solution 24 hours after instillation of the test compound.

The test substance was slight to moderately irritating to the eye. According Directive 67/548 EEC a classification is not required - however according GHS a classification as Eye Irrit.2; H319 is justified, based on a cornea score>1and a conjunctiva score>2.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

In the key-studyfor skin irritation/corrosion, three white New-Zealand rabbits were treated with 0.5 ml of undiluted test substance. The test item remained under semiocclusion on the skin for 4 hours. Treated animals were inspected for skin effects (erythma, oedema) after removal of patches and after 1, 2, 3 and 7 days. Total observation time was 7 days. For each animal the DRAIZE scores recorded approx. 24, 48, and 72 hours after application. An erythema score of 0.9 for erythema and 0.7 for edema were reported. Skin effects were fully reversible after 7 days and 72 hours, respectively.

In the key-study for eye irritation, 100 µl test compound was instilled into the conjunctival sac of one eye of each of 3 rabbits. The lids were then gently held together for about one second. the other eye remained untreated and served as control. The treated eye was washed out with physiological NaCl solution 24 hours after instillation of the test compound. The irritation scores / mean irritation scores were calculated for cornea, iris, erythema and swelling (chemosis) of the conjunctivae were calculated according to Draize at 24, 48 and 72 hours.

A cornea score > 1, an iris score = 0 was determined. The conjunctiva score was > and the chemosis was = 0.9. All effects were reversible within 14 or 7 days.


Justification for selection of skin irritation / corrosion endpoint:
The most reliable study was used as key study and for classification.

Justification for selection of eye irritation endpoint:
The most reliable study was used as key study and for classification.

Effects on eye irritation: irritating

Justification for classification or non-classification

m-chloroaniline was slightly irritating to the skin, but the measured score values were not sufficient for classification.

The test substance was slight to moderately irritating to the eye. According Directive 67/548 EEC a classification is not required - however according GHS a classification as Eye Irrit.2; H319 is justified, based on a cornea score>1and a conjunctiva score>2.