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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: Study with basic documentation which meets basic scientific principles.
Principles of method if other than guideline:
Evaluation of skin reactions in rabbits following 24-hr exposure.
GLP compliance:
no
Remarks:
pre-dates GLP
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
not specified
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
Amount(s) applied (volume or weight with unit): 0.01 ml of undiluted sample.
Duration of treatment / exposure:
24 hours
Observation period:
No data
Number of animals:
5
Irritation parameter:
overall irritation score
Basis:
other: No data
Time point:
other: 24h
Score:
1
Max. score:
10
Reversibility:
no data
Irritant / corrosive response data:
Isopropyl acetate received a Grade 1 in this assay (following administration of 0.01 ml ) indicating least visible capillary injection with the undiluted material.
Interpretation of results:
other: no to slight irritation
Remarks:
Criteria used for interpretation of results: expert judgment
Conclusions:
Interpretation must be made in the context of no occlusion during the exposure
Executive summary:

Smyth et al (1954) reported Grade 1 irritation, the least visible capillary injection, following application of undiluted isopropyl acetate to the clipped skin of rabbits for 24 hours. This is interpreted as to indicate "no to slight irritation" potential. However, the study was performed without occlusion.

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:
other: Study with basic documentation.
Principles of method if other than guideline:
Eye injury was recorded in a 10-grade ordinal series and was based upon the degree of corneal necrosis that results from instillation of 0.5 ml of 1% aqueous solution in the eye with results read 24 hours later. Grade 1 is at most a very small area of necrosis resulting from 0.5 ml of undiluted chemical in the eye. Grade 10 indicates a severe burn from 0.5 ml of a 1% solution in water.
GLP compliance:
no
Remarks:
study pre-dates GLP
Species:
rabbit
Strain:
New Zealand White
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
Amount applied: 0.5 ml or less.
Duration of treatment / exposure:
no data
Observation period (in vivo):
no data
Number of animals or in vitro replicates:
no data
Irritation parameter:
other: corneal necrosis
Basis:
other: no data
Score:
2
Max. score:
10
Reversibility:
not specified
Undiluted isopropyl acetate received a Grade 2 score in this assay.
Interpretation of results:
moderately irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
isopropyl acetate received a rating of 2 in this assay.
Executive summary:

Smyth et al (1954) reported Grade 2 corneal necrosis (on a scale of 1 min -10 max) following instillation of undiluted isopropyl acetate into rabbit eyes. This is interpreted to indicate moderate irritation potential.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Justification for selection of skin irritation / corrosion endpoint:
best data available

Justification for selection of eye irritation endpoint:
Best available data.
Smyth et al (1954) reported Grade 2 corneal necrosis (on a scale of 1 min -10 max) following instillation of undiluted isopropyl acetate into rabbit eyes. This is interpreted to indicate moderate irritation potential.

Effects on eye irritation: moderately irritating

Justification for classification or non-classification