Registration Dossier

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:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
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.