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: Adopted according to OECD SIDS (publicly available peer reviewed source). Original document not available.

Data source

Referenceopen allclose all

Reference Type:
secondary source
Title:
SIDS Initial Assessment Report For SIAM 20 (Malonic Acid Diesters: Dimethylmalonate, 108-59-8; Diethylmalonate, 105-53-3), April 19-22, 2005 Paris.
Author:
OECD SIDS
Year:
2005
Bibliographic source:
UNEP Publications
Reference Type:
study report
Title:
Unnamed
Year:
1992

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Purity: ca. 99 %
Impurities from the production process: methanol (ca. 0.3 %) and dimethyl-methylmalonate (ca. 0.2%)
Physical state: liquid, colorless

Test animals / tissue source

Species:
rabbit
Strain:
other: Small white Russian, Chbb: HM, SPF
Details on test animals or tissues and environmental conditions:
Sex: male
Source: Fa. Dr. Karl Thomae GmbH, Biberach
Weight at study initiation: 2 - 3 kg
Number of animals: 3
Control: untreated second eye of the animals

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated second eye
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
24 h
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing
- Time after start of exposure: 24 h

SCORING SYSTEM: Draize scheme

TOOL USED TO ASSESS SCORE: Investigation of intactness of the eyes prior to the experiment and 24 h, 48 h, 72 h, 6 d p.a. with fluorescein.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 6 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 6 days
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24, 48, 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 6 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 6 days
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within: 6 days
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24, 48, 72 h
Score:
0.67
Max. score:
2
Reversibility:
fully reversible within: 6 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: All 3 animals had the same scores.
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24, 48, 72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritant / corrosive response data:
DESCRIPTION OF LESIONS:
1 h p.a. : Medium grade erythema of the conjunctivae and slight corneal opacity as well as excretion of a white exsudate from the treated eyes was observed in all 3 animals. 2 animals had additionally a very slight edema, one a marked edema.
24 h p.a.: All 3 animals showed medium grade erythema and marked edema of the conjunctivae, indications of an irritation of the iris with intact pupil reaction. The cornea was slightly opaque (in 2 animals the whole area was affected, in 1 animal about half of the area). Exsudation was still observed in one animal.
48 h p.a.: The medium grade erythema was unchanged in all animals, while edema was reduced in 2 animals. 2 animals still showed iridal irritation while it was reduced in one animal. In 2 animals corneal opacity had increased slightly. Exsudation was still observed in one animal.
72 h p.a. : The medium grade erythema was unchanged in all animals, while edema was reversed. Iridal irritation was still observed in one animal. Slight corneal opacity was seen in 2 animals covering one and 3 quarts of the surface respectively while in 1 animal corneal opacity was still unchanged.
6 d p.a. : Corneal and iris reactions were reversed completely in all animals, very slight conjunctival irritation and chemosis was observed in 2 animals.
8 d p.a.: All effects were reversible by day 8.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information (Category 2)