Registration Dossier

Administrative data

Description of key information

Based on read across from PETMP, supported by QSAR, TMPMP is considered not irritating to skin.

Based on read-across from PETMP, TMPMP is considered not irritating to eyes.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Justification for type of information:
see attached category report and justificaton
Reason / purpose:
read-across source
Species:
rabbit
Irritation parameter:
erythema score
Basis:
mean
Remarks:
3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
edema score
Basis:
mean
Remarks:
3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Interpretation of results:
GHS criteria not met
Conclusions:
Based on QSAR prediction and read-across from PETMP, TMPMP is considered not irritating to 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:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
see attached category justification
Reason / purpose:
read-across source
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Number of animals or in vitro replicates:
1+2
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
Only very slight conjunctival reactions, including very slight chemosis (grade 1), very slight redness of the conjunctiva (grade 1) and clear discharge, were observed in all animals on day 1.
No other ocular reactions were observed during the study. Mean scores calculated for each animal over 24, 48 and 72 hours were 0.0, 0.0 and 0.0 for chemosis, redness of the conjunctiva, iris lesions and corneal opacity.
Interpretation of results:
GHS criteria not met
Conclusions:
Based on read-across from PETMP, supported by QSAR, TMPMP is considered not irritating to eyes
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

Based on read across from PETMP, TMPMP is considered not irritating to skin and not irritating to eyes.