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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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:
other: Guideline study without detailed documentation
Principles of method if other than guideline:
This test followed the revised Federal Hazardous Substances Act (FHSA) procedure that had been proposed by the FDA (Edwards, 1972), with a 4-hour rather than 24-hour exposure.
GLP compliance:
no
Species:
rabbit
Strain:
not specified
Details on test animals or test system and environmental conditions:
No details provided.
Type of coverage:
occlusive
Preparation of test site:
other: intact and abraded skin
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
No details provided.
Duration of treatment / exposure:
4 hours
Observation period:
at 4, 24, and 48 hours
Number of animals:
No details provided.
Details on study design:
TEST SITE
- Area of exposure: 2 intact sites and 2 abraded sites per animal
- % coverage: not reported
- Type of wrap if used: patch (unspecified)


REMOVAL OF TEST SUBSTANCE
- Washing (if done): not reported
- Time after start of exposure: not reported


SCORING SYSTEM: see below
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 4, 24, 48 hr
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: no irritation observed
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 4, 24, 48 hr
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: no irritation observed
Irritation parameter:
other: tissue destruction
Basis:
mean
Time point:
other: 4, 24, 48 hr
Score:
0
Max. score:
6
Reversibility:
other: not applicable
Remarks on result:
other: no corrosion observed in any (0) of the 6 sites tested
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Not irritating.
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:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable for assessement
Principles of method if other than guideline:
Method: Draize Test
Eye injury in rabbits records the degree of corneal necrosis from various volumes and concentrations of chemical, as detailed by Carpenter and Smyth Am. J. Ophth. 29 :1363, 1946
GLP compliance:
no
Remarks:
pre-dates GLP
Species:
rabbit
Strain:
other: Albino
Vehicle:
unchanged (no vehicle)
Details on study design:
Before instillation, the rabbit eyes were treated with 5% aqueous solution of fluorescein sodium. 20 sec later, the eyes were flushed with distilled water. After a 2 h interval to allow the eye to return to normal, 0.005 ml of the undiluted test substance is applied to the center of the cornea while the lids are retracted. About one minute later, the lids are released. This procedure is necessary to prevent the removal of a portion dose by the very efficient wiping system of the lids before intimate contact has been made with the eye. Eighteen to 24 h later, the eye is examined in strong diffuse daylight, then stained with fluorescein, and the injury scored. Guided by the result and a table of injury grades, additional applications are made until the chemical is assigned. If large volumes are applied, the lids are held closed for one minute before the animal is released.


Grade 1 in the table indicates at most a very small area of necrosis resulting from 0.5 ml of undiluted chemical in the eye ; Grade 5 indicates a so-called severe burn from 0.005 ml and grade 10 indicates a severe burn from 0.5 ml of a 1% solution in water or propylene glycol.

The test substance caused a grade 5 injury to the rabbit eye

Interpretation of results:
highly irritating
Remarks:
Migrated information Criteria used for interpretation of results: not specified
Conclusions:
Highly irritating
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Justification for selection of skin irritation / corrosion endpoint:
best available data. Study record #2 concerns propan-1-ol.

Effects on eye irritation: highly irritating

Justification for classification or non-classification