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Administrative data

Description of key information

skin irritation
rabbit: max. primary irritiation index 0.83 (24h, CFTA 1967): not irritating

eye irritation
rabbit: not-irritating (CFTA 1967)

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)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Principles of method if other than guideline:
no data
GLP compliance:
not specified
Species:
rabbit
Strain:
not specified
Type of coverage:
not specified
Preparation of test site:
not specified
Vehicle:
not specified
Controls:
not specified
Duration of treatment / exposure:
24 hours
Observation period:
48 hours
Number of animals:
6
Irritation parameter:
erythema score
Basis:
animal: no data
Time point:
other: 72 hours
Reversibility:
no data
Remarks on result:
other: Slight erythema was observed when the patch was removed, and the severity decreased in all animal s by 72 hours. There was no apparent difference between abraded and intact skin.
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 72 hours
Score:
<= 0.83
Reversibility:
no data
Other effects:
no data
Interpretation of results:
not irritating
Remarks:
Migrated information
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:
data from handbook or collection of data
Principles of method if other than guideline:
no data
GLP compliance:
not specified
Species:
rabbit
Strain:
not specified
Vehicle:
not specified
Controls:
not specified
Duration of treatment / exposure:
Volume of 0.1 ml was instilled into one eye of 6 albino rabbits . The other eye remained untreated .
Observation period (in vivo):
The eyes were examined at 24, 48, and 72 hours after treatment.
Number of animals or in vitro replicates:
6 albino rabbits
Irritation parameter:
overall irritation score
Basis:
other: no data
Time point:
other: 24, 48, and 72 hours
Remarks on result:
other: no irritation was observed at any timepoint.
Other effects:
no data
Interpretation of results:
not irritating
Remarks:
Migrated information
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

In vivo data generated by the Kolmar Research Center and published by BUA (CFTA 1967) for DEHA do not show a skin or eye irritation potential of the substance. Undiluted test substance was applied for 24 hours to the intact or abraded skin of 6 rabbits. Despite the long exposure time only slight erythema were observed after removal of the patch, severity of which decreased further within the following 72 hours. No difference between intact or abraded skin was detected. The maximum value for the mean primary irritation index was 0.83. Instillation of 0.1ml of DEHA into the eyes of 6 albino rabbits did not elicit a visible response.

Justification for classification or non-classification

The findings in both the skin and eye irritation studies do not meet the critera for classification as a skin irritant or as an eye irritant according to 67/548/EEC or EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.

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