Registration Dossier

Administrative data

Description of key information

not irritant to skin (technical product: 50% MPAAU in water) nor to eye 
Respiratory irritation: waived

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:
from 2003-10-22 till 2004-03-27
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study with GLP without deviations.
Justification for type of information:
QSAR not applicable for organic salt compound MPAAU.
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
occlusive
Preparation of test site:
other: clipping
Vehicle:
water
Controls:
other: The untreated other side served as control.
Amount / concentration applied:
0.5 ml technical product
Duration of treatment / exposure:
4 hours
Observation period:
Animals were examined for signs of erythema and oedema at 1, 24, 48 and 72 hours after patch removal.
Number of animals:
3
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect
Irritant / corrosive response data:
none
Other effects:
no effect observed.
Interpretation of results:
GHS criteria not met
Conclusions:
As the mean value for erythema or oedema were "0" for all 3 animals after a test period of 4h and a observation period of 24,48 and 72 h, the test material is be considered as a "non irritant".
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation, other
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from 1983-08-18 till 1983-08-29
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study without GLP.
Justification for type of information:
QSAR and in-vitro methods not available at that time.
QSAR not applicable for organic salt compound MPAAU.
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
May 12, 1981
Deviations:
no
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Vehicle:
unchanged (no vehicle)
Controls:
other: the left eye of the test animals remained untreated
Amount / concentration applied:
0.1 ml of the test item was placed into the conjunctival sac of the right eye of each animal.
Number of animals or in vitro replicates:
3 animals
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1h, 24h, 48h, 72h, 7 days
Score:
0
Max. score:
0
Reversibility:
other: no effect
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1h, 24h, 48h, 72h, 7 days
Score:
0
Max. score:
0
Reversibility:
other: no effect
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 24 h
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 1 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 24 h
Irritant / corrosive response data:
not irritating
Other effects:
The body weight in 2 animals was decreased during the test period.
Interpretation of results:
GHS criteria not met
Conclusions:
The test item is non irritant and not corrosive when applied to the rabbit eye mucosa.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for selection of skin irritation / corrosion endpoint:
GLP study with Klimisch score 1 available.

Justification for selection of eye irritation endpoint:
GLP study with Klimisch score 1 available.

Justification for classification or non-classification

According to the GHS criteria, listed in Annex I, the substance does not have to be classified as a hazardous substance regarding irritation/corrosion.