Registration Dossier

Administrative data

Description of key information

No skin irritation was observed in in-vivo testing.

Slight reversible eye irritation was seen in one animal during an in-vivo test.

Testing was performed in the US in 1994 on a 25% actives commercial grade solution. The absence of adverse effects indicates that classification is not required, although if isolated from water, the pure substance may cause mild irritant effects.

The substance is typically manufactured and supplied in water.

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:
4 hours exposure
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Justification for type of information:
US Study performed 1994 with 6 rabbits.
Well documented, but 25% commercial grade solution used for testing
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
6-rabbits for US
GLP compliance:
not specified
Specific details on test material used for the study:
Commercial grade material used at ca 25% solids
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
0.5 ml, undiluted as supplied (ie 25% actives)
Duration of treatment / exposure:
4 hours
Observation period:
Up to 72 hours (all animals with no score at this point)
Number of animals:
6
Irritation parameter:
erythema score
Basis:
animal: 1 animal
Time point:
other: 1 hour
Score:
1
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal: All animals
Time point:
24 h
Score:
0
Max. score:
0
Reversibility:
other: not relevant
Irritation parameter:
edema score
Basis:
animal: All animal
Time point:
24 h
Score:
0
Max. score:
0
Reversibility:
other: not relevant
Irritant / corrosive response data:
Only one animal showed a slight effect at 1 hour after removal of dressings. This resolved prior to next observation at 24 hours.
No other animals showed any adverse effect.
Interpretation of results:
GHS criteria not met
Conclusions:
Although it was uncessary to use 6 animals, the work was performed in accordance with common practice in the US at this period.
Only slight transitory effects were seen in one animal 1 hour after removal of dressings.
The material tested was as supplied as ca 25% actives. The very low irritation of the 25% solution would suggest that the substance need not be classified as irritating to the skin.
The pH of the material was unknown, but current production is for pH 6 - 7.
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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Justification for type of information:
Two rabbits tested following US guidelines from 1994.
A 25% commercial grade material was tests, but in view of the absence of significant effects, it is considered adequate to conclude that the substance is not irritating to eyes.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
Only 2 animals tested. Method considered valid in 1994.
GLP compliance:
not specified
Specific details on test material used for the study:
Commercial grade material with ca 25% actives
Species:
rabbit
Strain:
New Zealand White
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.01 ml applied unchanged
Observation period (in vivo):
Observation period for 3 days.
Number of animals or in vitro replicates:
Two animals
Irritation parameter:
cornea opacity score
Basis:
animal: All animals
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Irritation parameter:
iris score
Basis:
animal: All animals
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Irritation parameter:
chemosis score
Basis:
animal: All animals
Time point:
24/48/72 h
Score:
0
Max. score:
1
Reversibility:
fully reversible within: 24 hours
Irritant / corrosive response data:
One animal showed conjuntival rednees for 48 hours and chemosis immediately after treatment (resolved within 24 hours).
The second animal (unwashed eye) showed no adverse effects.
Interpretation of results:
GHS criteria not met
Conclusions:
Although only two animals were tested, it canbe concluded that the material was not irritating to the eye.
The commercial grade material with ca 25% actives was tested, but in view of the low level of effect seen, it can be concluded that the substance is unlikely to be irritating to the eye.
The pH of the tested material is not known, but the current production material has pH 6 - 7.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Justification for classification or non-classification