Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

The substance is subject to EC harmonization (Index No. 607-100-00-9); thus it will be classified according to Regulation EC no. 1272/2008 as an eye irritant, Category 2, and respiratory irritant, STOT-SE, Category 3.

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, precedes establishment of GLP. Documentation is limited.
Qualifier:
equivalent or similar to guideline
Guideline:
other: 16 CFR 1500.41, Federal Hazardous Substances Act, USA
Deviations:
no
Principles of method if other than guideline:
Dermal exposure to intact and abraded skin of rabbits under occlusive patch for 24 hours, with an observation period of 72 hours after application.
GLP compliance:
no
Remarks:
preceeds establishment of GLP
Species:
rabbit
Strain:
other: albino
Details on test animals or test system and environmental conditions:
male and female.
Animals were housed individually in metal cages suspended above the droppings.
Food and water were available ad libitum.
Type of coverage:
occlusive
Preparation of test site:
other: intact and abraded
Vehicle:
other: 25% ethanol
Controls:
no
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
24 hour exposure
Observation period:
72 hours after administration of material
Number of animals:
6 each, abraded and intact skin
Details on study design:
The skin of each rabbit was prepared for treatment by prior close clipping of the hair with an electric clipper. The skin of rabbits in one of the two groups was abraded by producing shallow incisions with a scalpel blade over an area of skin measuring one inch by one inch.
The paste was applied to a rubber dental dam and placed in contact with the prepared abdominal skin of each rabbit. Adhesive tape was placed over the dental dam and the entire abdomen was wrapped with an elastic bandage to insure constant contact of the compound for a 24-hour period.
At the end of the 24 hour period of drug contact, and at 48 and 72 hours, the bandages were removed and the skin reactions were graded.
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24
Score:
0
Max. score:
8
Remarks on result:
other: Duration of exposure was 24 hours.
Irritant / corrosive response data:
BTDA did not produce any irritating properties when applied to the skin of rabbits.
Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
1,3-Isobenzofurandione, 5,5'-carbonylbis- (BTDA) was tested for skin irritation in the intact and abraded skin of albino rabbits, under occlusive conditions, for 24 hours. The results indicate the substance is 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:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: guideline study; precedes establishment of GLP. Documentation is limited.
Qualifier:
according to guideline
Guideline:
other: 16 CFR 1500.42, Federal Hazardous Substances Act, USA
Principles of method if other than guideline:
Test material is placed in one eye of six albino rabbits, and the eyes are examined and graded for ocular irritation 24, 48 and 72 hours after administration.
GLP compliance:
no
Remarks:
preceeds establishment of GLP
Species:
rabbit
Strain:
other: albino
Details on test animals or tissues and environmental conditions:
male and female.
Individually housed in metal cages suspended above the droppings.
Food and water were available ad libitum.
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
3 mg applied to one eye.
Duration of treatment / exposure:
7 days.
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6
Details on study design:
The untreated eye of each rabbit served as the control. Prior to application of the compound and again at the termination of the 7-day observation period, the eyes of each animal were examined with the use of 2% sodium fluorescein and a small-window ultraviolet, quartz, mercury pencil lamp. Other observations for eye irritation were made frequently on the day of application and again at 24, 48 and 72 hours, and at 4 and 7 days thereafter. Eye irritation was graded and recorded according the method of Draize in "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics", 1959.
The treated eye was not washed.
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 h and later
Score:
0.1
Max. score:
8
Reversibility:
fully reversible within: 24 h
Irritant / corrosive response data:
One rabbit showed mild irritation of the exposed eye one hour after instillation of the test material. This reaction appeared normal within 24 hours.
Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
1,3-Isobenzofurandione, 5,5'-carbonylbis- (BTDA) was tested for eye irritation in albino rabbits, and evaluated for up to 7 days. The results indicate the substance is not irritating.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

1,3-Isobenzofurandione, 5,5'-carbonylbis- (BTDA) was tested for eye and skin irritation in albino rabbits. The results indicate the substance is not irritating to either eye or skin. However, an EC harmonized classification exists for eye irritaton, Category 2, at concentrations greater than 1%. It is also classified as a respiratory irritant, Specific Target Organ Toxicity, single exposure, Category 3. Therefore, the substance is classified.


Justification for classification or non-classification

Experimental data indicates the substance has not demonstrated irritation to either eye or skin. However, as the substance is subject to EC harmonization (index # 607 -100 -00 -9), it will be classified according to the Regulation EC No. 1272/2008 as an eye irritant, Category 2, and Specific Target Organ Toxicity, single exposure, Category 3.