Registration Dossier

Administrative data

Description of key information

HQEE is not irritating to skin and slightly irritating to the eye.

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:
2 (reliable with restrictions)
Qualifier:
no guideline followed
Principles of method if other than guideline:
O.5 g of substance was applied to the skin of 5 guinea pigs for 24 hours under an occlusive dressing.
GLP compliance:
no
Remarks:
However was subject to Quality Assurance
Species:
guinea pig
Strain:
other: Cr1:(HA) BR Hartley
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Remarks:
Moistened with water
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
24 hours
Observation period:
15 days
Number of animals:
5 Females
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24/48 hours
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 15 days
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Irritant / corrosive response data:
No signs of irritation were observed over the 15 day observation period
Interpretation of results:
other: CLP criteria (Reg 1272/2008) are not met
Conclusions:
HQEE was not irritating to guinea pig 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:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no
Remarks:
However was subject to Quality Assurance
Species:
rabbit
Strain:
New Zealand White
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
100mg
Duration of treatment / exposure:
Not applicable
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6 animals (3 washed and 3 unwashed)
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24/48/72 hours
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24/48/72 hours
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24/48/72 hours
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: The study report only reports the conjunctival effects as "slight". Thus it is not possible to provide the actual scores.
Irritant / corrosive response data:
In unwashed eyes signs of slight irritation consisted of moderate erythema (3/3) and slight oedema (1/3) of the nictitating membranes. All effects were fully reversible by Day 7.

The report does not provide quantitative eye scoring data.

Interpretation of results:
other: CLP criteria (Reg 1272/2008) are not met
Conclusions:
HQEE was slightly irritating to rabbit eye
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

HQEE is not irritating to skin and slightly irritating to the eye in reliable in vivo studies.

Justification for selection of skin irritation / corrosion endpoint: Only one study available. The study is Klimisch 2.

Justification for selection of eye irritation endpoint: Only one study available. The study is Klimisch 2.

Justification for classification or non-classification

HQEE does not cause skin irritation and the degree of eye irritancy is insufficient to meet the classification criteria. Hence HQEE is not classified for skin or eye irritancy.