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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

H318 Causes serious eye damage.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation / corrosion, other
Remarks:
QSAR
Type of information:
(Q)SAR
Remarks:
QSAR
Adequacy of study:
key study
Study period:
2017
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
results derived from a valid (Q)SAR model and falling into its applicability domain, with adequate and reliable documentation / justification
Justification for type of information:
QSAR
Principles of method if other than guideline:
QSAR
GLP compliance:
no
Irritation / corrosion parameter:
other: QSAR
Run / experiment:
QSAR
Vehicle controls validity:
not specified
Remarks:
QSAR
Negative controls validity:
not specified
Remarks:
QSAR
Positive controls validity:
not specified
Remarks:
QSAR
Remarks on result:
no indication of irritation
Remarks:
QSAR
Interpretation of results:
GHS criteria not met
Conclusions:
The skin irritation potential of the Indole was predicted employing two different in silico approaches: the QSAR statistical model as provided by ACD/Percepta and the decision rule system provided by Toxtree. The two predictors were employed in order to integrate and enhance the reliability of the prediction. Since Toxtree did not provide any specific prediction, based on ACD/Percepta prediction Indole was predicted as NOT SKIN IRRITANT, and the prediction was assessed as moderate reliable.
Executive summary:

The skin irritation potential of the Indole was predicted employing two different in silico approaches: the QSAR statistical model as provided by ACD/Percepta and the decision rule system provided by Toxtree. The two predictors were employed in order to integrate and enhance the reliability of the prediction. Since Toxtree did not provide any specific prediction, based on ACD/Percepta prediction Indole was predicted as NOT SKIN IRRITANT, and the prediction was assessed as moderate reliable.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation, other
Remarks:
Method written by Carpenter and Smyth in 1946.
Type of information:
experimental study
Remarks:
Method written by Carpenter and Smyth in 1946.
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
method Smyth 1962
Principles of method if other than guideline:
Method written by Carpenter and Smyth in 1946. See it in the attachement page 11th of the book.
GLP compliance:
no
Species:
rabbit
Strain:
not specified
Vehicle:
not specified
Irritation parameter:
cornea opacity score
Basis:
other: not specified
Time point:
24 h
Score:
>= 8
Max. score:
10
Reversibility:
not fully reversible within:
Remarks on result:
probability of severe irritation
Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
H318 Eye dam 1. Causes serious eye damage.
Executive summary:

It is classifed as H318 Eye dam 1. Causes serious eye damage.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

Eye dam 1. H318 Causes serious eye damage.