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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Eye irritation

Currently viewing:

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: The study was performed according to methods similar to OECD 405, not accoring to GLP. Details on test substance and results are limited.

Data source

Reference
Reference Type:
publication
Title:
Studies on eye irritation caused by chemicals in rabbits -1. A quantitative structure-activity relationships approach to primary eye irritation of chemicals in rabbit.
Author:
Sugai, S., Murata, K. Kitagaki, T., Tomita, I.
Year:
1990
Bibliographic source:
The Journal of Toxicological Sciences, Vol. 15, 245-262

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Citraconic anhydride
EC Number:
210-459-0
EC Name:
Citraconic anhydride
Cas Number:
616-02-4
Molecular formula:
C5H4O3
IUPAC Name:
3-methyl-2,5-dihydrofuran-2,5-dione
Details on test material:
Name: citraconic anhydride

Test animals / tissue source

Species:
rabbit
Strain:
other: Japanese white rabbits
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Takeo breeder NII-Electronic Library Service
- Age at study initiation: no data
- Weight at study initiation: 2.0-2.2 kg
- Housing:housed in metal cages (39 X 40 X 44 cm)
- Diet (e.g. ad libitum): fed the RC4 diet (Oriental Yeast Co., Tokyo, Japan), ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period:

ENVIRONMENTAL CONDITIONS
- Temperature (°C):25 ± 1°C
- Humidity (%): 55 ± 5%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: no data

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The right eye was served as a blank.
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
single application
Observation period (in vivo):
The eyes were examined and the grade of ocular reaction was recorded 1, 4, 24, 48, 72, 96hr, 7, 14 and 21 days after the treatment of chemicals.
Number of animals or in vitro replicates:
3 females
Details on study design:
REMOVAL OF TEST SUBSTANCE: none

SCORING SYSTEM: Corneal opacity, erythema, chemosis, secreta and iritis were classified according to the Draize score

TOOL USED TO ASSESS SCORE: no data

Results and discussion

In vivo

Results
Irritation parameter:
other:
Basis:
other: all animals
Time point:
other: up to 21 days
Reversibility:
not reversible
Remarks on result:
other: Score III: Corrosive
Irritant / corrosive response data:
The only data given is that the outcome of the test is corrosive for this test substance. This is confirmed by a QSAR.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Criteria used for interpretation of results: expert judgment
Conclusions:
The test substance is corrosive to the eye according to the Draize scoring method: Corneal involvement, irritation or eye damage that persists for more than 21 days after treatment.
Executive summary:

The test substance is corrosive to the eye according to the Draize scoring method: Corneal involvement, irritation or eye damage that persists for more than 21 days after treatment.