Registration Dossier

Administrative data

Description of key information

GDMA is irritating to eyes (Eye Irrit 2), but not irritating to skin.

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:
1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
yes
Remarks:
24 h exposure, no scoring at 48 h
GLP compliance:
no
Remarks:
GLP was not mandatory at time of study
Specific details on test material used for the study:
not specified
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
24 h
Observation period:
72 h
Number of animals:
6
Irritation parameter:
erythema score
Remarks:
intact skin
Basis:
mean
Remarks:
no scoring at 48 h
Time point:
24/48/72 h
Score:
0.17
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Remarks:
no scoring at 48 h
Time point:
24/48/72 h
Score:
0.08
Max. score:
4
Reversibility:
fully reversible
Interpretation of results:
GHS criteria not met
Conclusions:
GDMA is not irritating to skin. The deficiency of the study (no 48-h score) is more than compensated by the longer exposure time (24 instead of 4 h) and the occlusive exposure conditions.
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:
1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Deviations:
yes
Remarks:
only 7 d observation time
GLP compliance:
no
Remarks:
GLP was not mandatory at the time of the study
Specific details on test material used for the study:
not specified
Species:
rabbit
Strain:
New Zealand White
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
no washing
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
6
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0.39
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks:
one animal showed grade-1 opacity at D7
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0.39
Max. score:
2
Reversibility:
fully reversible within: 3 d
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
2.61
Max. score:
3
Reversibility:
fully reversible within: 7 d
Remarks:
4 animals showed erythema (grade 1-3) at D7
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
2.11
Max. score:
4
Reversibility:
not fully reversible within: 7 d
Remarks:
1 animal showed grade 1 chemosis on D7
Irritant / corrosive response data:
see table below for individual animal data
Rabbit # Time [h] cornea iris conjunctivae  
        redness swelling
1 24 1 1 3 4
  48 1 1 3 4
  72 1 1 3 4
  average 1.00 1.00 3.00 4.00
2 24 1 1 3 2
  48 0 0 3 2
  72 0 0 2 0
  average 0.33 0.33 2.67 1.33
3 24 0 0 3 4
  48 0 0 3 1
  72 0 0 2 0
  average 0.00 0.00 2.67 1.67
4 24 0 0 3 4
  48 1 1 3 2
  72 0 0 2 0
  average 0.33 0.33 2.67 2.00
5 24 1 1 3 4
  48 0 0 3 1
  72 0 0 2 1
  average 0.33 0.33 2.67 2.00
6 24 1 1 3 4
  48 0 0 2 1
  72 0 0 1 0
  average 0.33 0.33 2.00 1.67
Time [h] cornea iris conjunctivae  
      redness swelling
average 24 0.67 0.67 3.00 3.67
score 48 0.33 0.33 2.83 1.83
72 0.17 0.17 2.00 0.83
24+48+72 0.39 0.39 2.61 2.11
Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
GDMA should be classified as Eye Irrit 2 - H319.
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

GDMA does not show significant skin irritation in rabbits exposed for 24 h.

GDMA is shows eye irritation of sufficient severity for classification as Eye Irrit 2. The corneal effects observed in a single animal at Day 7 is assumed to have be reversible if the observation time had been extended to 21 days. Therefore, classification as Eye Dam 1 seems overly conservative.