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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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: Well conducted study according to recognised OECD test methods.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Tetrahydrophthalic anhydride
EC Number:
247-570-9
EC Name:
Tetrahydrophthalic anhydride
Cas Number:
26266-63-7
IUPAC Name:
3a,4,7,7a-tetrahydro-2-benzofuran-1,3-dione
Details on test material:
- Name of test material (as cited in study report): Tetrahydrophthalsàureanhydrid (THPSA)
- Physical state: Solid
- Analytical purity: > 99.0 %
- Lot/batch No.: Verformung der Nachtschicht vom 02./03.03.1988
- Storage condition of test material: Protected from light and humidity

Test animals / tissue source

Species:
rabbit
Strain:
other: Weiss russen
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Biberach, Germany
- Weight at study initiation: 2.7 kg
- Housing:
- Diet (e.g. ad libitum): K4 rabbit diet, Ssniff Spezialfutter GmbH, ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 21 deg C
- Humidity (%): 55 - 65 %
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hours light / 12hours dark

IN-LIFE DATES: From: 1988-05-27 To: 1988-05-27

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 cm3
Duration of treatment / exposure:
Single exposure
Observation period (in vivo):
1 hour
Number of animals or in vitro replicates:
1
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not done

SCORING SYSTEM: Draize scale as described in OECD test guideline

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 1 hour
Score:
2
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 1 hour
Score:
2
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 1 hour
Score:
3
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 1 hour
Score:
2
Max. score:
2

Any other information on results incl. tables

Study terminated after 1 hour due to severe effects observed

Applicant's summary and conclusion

Interpretation of results:
highly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Tetrahydrophthalic anhydride is highly irritating to the eye
Executive summary:

Acute eye irritation has been investigated according to OECD test guidelines. The eye of a single animal was exposed, resulting in severe ocular reaction. The substance is regarded as being highly irritant to the eye.