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Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
July 1990 - August 1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Dimethyl succinate
EC Number:
203-419-9
EC Name:
Dimethyl succinate
Cas Number:
106-65-0
Molecular formula:
C6H10O4
IUPAC Name:
dimethyl succinate
Details on test material:
- Name of test material (as cited in study report): Bernsteinsauredimethylester
- Analytical purity: 99.7%
- Purity test date: 1991-01-21
- Lot/batch No.: OP.15 vom 07.05.90
- Stability under test conditions: Stable
- Storage condition of test material: 4 deg C, protected from light

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG, Kastengrund
- Age at study initiation: 3 - 5 months
- Weight at study initiation: 3.2 - 4.0 kg
- Housing: Metal cages
- Diet (e.g. ad libitum): Altromin 2123 rabbit diet, ad-libitum
- Water (e.g. ad libitum): Deionised water, ad-libitum
- Acclimation period:

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23 deg C
- Humidity (%): 30 - 70%
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark

IN-LIFE DATES: From: 1990-07-31 To: 1990-08-07

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): 100% (undiluted)
Duration of treatment / exposure:
Exposure at a single time point
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): After 24 hours with physiological saline at 37 deg C

SCORING SYSTEM: Accoding to Draize et.al. as described by the OECD test method

TOOL USED TO ASSESS SCORE: fluorescein - slit lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Max. score:
2
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.3
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2.3
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritant / corrosive response data:
Corneal opacity: In 2/3 animals corneal abnormalities were noted. Diffuse areas of opacity (score "1") were noted. In 1/3 animals easily discernible translucent areas (score of "2) with the whole cornea affected. The lesions were fully reversible after 7 days.
Iris inflammation: In 3/3 animals mild changes (score "1") were noted from 1 hour and remained for at least 72 hours.
Conjunctival redness: diffuse crimson colour to a diffuse beefy red (scores "2" and "3") were noted in all animals. The lesions were observed from 1 hour and remained for at least 72 hours. Recovery had occurred within 7 days.
Conjunctival chemosis: Significant swelling with a score of "3" was observed in 3/3 animals after 1 hour. In 2/3 animals swellings in different degrees of severity (scores "1" to "3") were noted from 24 - 72 hours. The lesions then gradually returned to normal and after 7 days no swelling was detectable.

Other effects:
None observed

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
The substance is irritating to the eye
Executive summary:

The potential irritating / corrosive effects following a single administration into the eye of rabbits has been investigated. Methods followed those described in OECD Test Guideline No. 405 and EC Directive 92/69/EEC B.5. A 0.1 mL aliquot was instilled into the conjunctival sac of one eye of each of 3 rabbits. The treated eyes were examined 1, 24, 48 and 72 hours and 7 days following exposure.

 

In all 3 animals reversible corneal lesions (scattered areas of opacity) were observed, present for at least 72 hours in 2 of the 3 animals. In all animals the iris was mildly injected for up to 72 hours after exposure. Well defined to marked redness of the conjunctivae was observed in all 3 animals after 1 hour and remained for a maximum of 72 hours. Marked chemosis of the conjunctivae was seen in all animals for a maximum of 72 hours post exposure. Complete recovery had occurred within 7 days of exposure.